Background: Intraoperative hypercapnia reduces the time to emergence from volatile anesthetics, but few clinical studies have explored the effect of hypercapnia on the emergence time from intravenous (IV) anesthesia. We investigated the effect of inducing mild hypercapnia during the recovery period on the emergence time after total IV anesthesia (TIVA). Methods: Adult patients undergoing transurethral lithotripsy under TIVA were randomly allocated to normocapnia group (end-tidal carbon dioxide [ETCO2] 35–40 mmHg) or mild hypercapnia group (ETCO2 50-55 mmHg) during the recovery period. The primary outcome was the extubation time. The spontaneous breathing-onset time, voluntary eye-opening time, and hemodynamic data were collected. Changes in the cerebral blood flow velocity in the middle cerebral artery were assessed using transcranial Doppler ultrasound. Results: In total, 164 patients completed the study. The extubation time was significantly shorter in the mild hypercapnia (13.9 ± 5.9 min, P = 0.024) than in the normocapnia group (16.3 ± 7.6 min). A similar reduction was observed in spontaneous breathing-onset time (P = 0.021) and voluntary eye-opening time (P = 0.008). Multiple linear regression analysis revealed that the adjusted ETCO2 level was a negative predictor of extubation time. Middle cerebral artery blood flow velocity was significantly increased after ETCO2 adjustment for mild hypercapnia, which rapidly returned to baseline, without any adverse reactions, within 20 min after extubation. Conclusions Mild hypercapnia during the recovery period significantly reduces the extubation time after TIVA. Increased ETCO2 levels can potentially enhance rapid recovery from IV anesthesia.

Background: Intraoperative hypercapnia reduces the time to emergence from volatile anesthetics, but few clinical studies have explored the effect of hypercapnia on the emergence time from intravenous (IV) anesthesia. We investigated the effect of inducing mild hypercapnia during the recovery period on the emergence time after total IV anesthesia (TIVA). Methods: Adult patients undergoing transurethral lithotripsy under TIVA were randomly allocated to normocapnia group (end-tidal carbon dioxide [ETCO2] 35–40 mmHg) or mild hypercapnia group (ETCO2 50-55 mmHg) during the recovery period. The primary outcome was the extubation time. The spontaneous breathing-onset time, voluntary eye-opening time, and hemodynamic data were collected. Changes in the cerebral blood flow velocity in the middle cerebral artery were assessed using transcranial Doppler ultrasound. Results: In total, 164 patients completed the study. The extubation time was significantly shorter in the mild hypercapnia (13.9 ± 5.9 min, P = 0.024) than in the normocapnia group (16.3 ± 7.6 min). A similar reduction was observed in spontaneous breathing-onset time (P = 0.021) and voluntary eye-opening time (P = 0.008). Multiple linear regression analysis revealed that the adjusted ETCO2 level was a negative predictor of extubation time. Middle cerebral artery blood flow velocity was significantly increased after ETCO2 adjustment for mild hypercapnia, which rapidly returned to baseline, without any adverse reactions, within 20 min after extubation. Conclusions Mild hypercapnia during the recovery period significantly reduces the extubation time after TIVA. Increased ETCO2 levels can potentially enhance rapid recovery from IV anesthesia.

Background: Intraoperative hypercapnia reduces the time to emergence from volatile anesthetics, but few clinical studies have explored the effect of hypercapnia on the emergence time from intravenous (IV) anesthesia. We investigated the effect of inducing mild hypercapnia during the recovery period on the emergence time after total IV anesthesia (TIVA). Methods: Adult patients undergoing transurethral lithotripsy under TIVA were randomly allocated to normocapnia group (end-tidal carbon dioxide [ETCO2] 35–40 mmHg) or mild hypercapnia group (ETCO2 50-55 mmHg) during the recovery period. The primary outcome was the extubation time. The spontaneous breathing-onset time, voluntary eye-opening time, and hemodynamic data were collected. Changes in the cerebral blood flow velocity in the middle cerebral artery were assessed using transcranial Doppler ultrasound. Results: In total, 164 patients completed the study. The extubation time was significantly shorter in the mild hypercapnia (13.9 ± 5.9 min, P = 0.024) than in the normocapnia group (16.3 ± 7.6 min). A similar reduction was observed in spontaneous breathing-onset time (P = 0.021) and voluntary eye-opening time (P = 0.008). Multiple linear regression analysis revealed that the adjusted ETCO2 level was a negative predictor of extubation time. Middle cerebral artery blood flow velocity was significantly increased after ETCO2 adjustment for mild hypercapnia, which rapidly returned to baseline, without any adverse reactions, within 20 min after extubation. Conclusions Mild hypercapnia during the recovery period significantly reduces the extubation time after TIVA. Increased ETCO2 levels can potentially enhance rapid recovery from IV anesthesia.

Background: Intraoperative hypercapnia reduces the time to emergence from volatile anesthetics, but few clinical studies have explored the effect of hypercapnia on the emergence time from intravenous (IV) anesthesia. We investigated the effect of inducing mild hypercapnia during the recovery period on the emergence time after total IV anesthesia (TIVA). Methods: Adult patients undergoing transurethral lithotripsy under TIVA were randomly allocated to normocapnia group (end-tidal carbon dioxide [ETCO2] 35–40 mmHg) or mild hypercapnia group (ETCO2 50-55 mmHg) during the recovery period. The primary outcome was the extubation time. The spontaneous breathing-onset time, voluntary eye-opening time, and hemodynamic data were collected. Changes in the cerebral blood flow velocity in the middle cerebral artery were assessed using transcranial Doppler ultrasound. Results: In total, 164 patients completed the study. The extubation time was significantly shorter in the mild hypercapnia (13.9 ± 5.9 min, P = 0.024) than in the normocapnia group (16.3 ± 7.6 min). A similar reduction was observed in spontaneous breathing-onset time (P = 0.021) and voluntary eye-opening time (P = 0.008). Multiple linear regression analysis revealed that the adjusted ETCO2 level was a negative predictor of extubation time. Middle cerebral artery blood flow velocity was significantly increased after ETCO2 adjustment for mild hypercapnia, which rapidly returned to baseline, without any adverse reactions, within 20 min after extubation. Conclusions Mild hypercapnia during the recovery period significantly reduces the extubation time after TIVA. Increased ETCO2 levels can potentially enhance rapid recovery from IV anesthesia.

Objective:To analyze the international status and level of clinical trial quality in China, and explore the advantages and value of scientific regulation of clinical research quality in China.Methods:The data is sourced from the relevant reports publicly released by the National Medical Products Administration (NMPA), the inspection reports and announcements published by the Center for Food and Drug Inspection of the NMPA, the inspection data displayed on the official website of the U.S. Food and Drug Administration (FDA), as well as clinical diagnosis and treatment guidelines issued by the National Comprehensive Cancer Network (NCCN) of United States and the Chinese Society of Clinical Oncology (CSCO) (data as of July 21, 2023). This data provides an analysis of the regulatory status of the implementation of clinical drug trials in China, inspection data, and the approval and market entry of new oncology drugs and feedback from their practical application.Results:The clinical trial quality inspection systems of China and the United States are generally aligned, with similar inspection subjects, focus areas, and public disclosure pathways. However, each has its characteristics in terms of inspection targets and types. The quality of clinical trial data in China has been continuously improving. Between 2009-2015 and 2016-July 2023, China underwent 25 and 20 FDA Bioresearch Monitoring (BIMO) inspections, respectively. The inspection results showing "No Action Indicated" (NAI) improved from 48.0% to 85.0%, while "Voluntary Action Indicated" (VAI) decreased from 44.0% to 15.0%. Official Action Indicated (OAI) measures were required in 2009 and 2012. Compared to the 2009-2015 period, there has been a clear upward trend in the quality of clinical trial data since 2016. From 2016 to July 2023, the number of new oncology drugs developed by Chinese pharmaceutical companies and included in professional guidelines has steadily increased. Specifically, 37 drugs (58.7%) were included in the 2022 edition of the CSCO guidelines, and 15 drugs (23.8%) were included in the 2023 edition of the NCCN guidelines, with 10 of these drugs featured in both guidelines.Conclusions:The implementation quality of clinical trials in China has gained a certain level of international recognition and competitiveness. This progress is attributed to national macro-level guidance, a unique institutional model, and clinical practices aligned with international standards. In the future, it will be necessary to further strengthen the scientific regulatory system and enhance clinical research capabilities to continue advancing the high-quality development of clinical trials.

Objective:To investigate the clinical efficacy of reconstruction with the hallux tissue flap for the fingertip defects of thumb and fingers based on the concept and technique of full reconstruction.Methods:From September 2022 to February 2023, the patients with thumb and fingertip defects who were reconstructed using the concept and technology of full reconstruction in Xuzhou Renci Hospital were respective analysised. Based on the degree of defect in the nail bed, bone, and soft tissue of the hand, a hallux osteo-onychocutaneous flap or hallux nail flap was designed and harvested from the same side of the toe, and free transplantation was performed to reconstruct the damaged fingertip. The wounds in the donor site that could not be sutured primarily were treated with dressing change. The surgical complications, the appearance of the reconstructed finger and donor site, Semmes-Weinstein monofilament (SWM) examination, 2-point discrimination (2PD) measurement, and patient satisfaction were regularly recorded. According to the functional evaluation criteria for thumb and finger reconstruction issued by the Hand Surgery of the Chinese Medical Association, the function of the reconstructed fingers was evaluated as excellent (13-15 points), good (9-12 points), fair (5-8 points), and poor (≤4 points). The patients were investigated whether they were satisfied with the outcomes.Results:A total of 8 patients (9 fingers) including 5 males and 3 females were enrolled. The average age was 32.4 years (range, 22-46 years). There were 1 thumb, 2 index fingers, 5 middle fingers, and 1 ring finger. 7 cases (8 fingers) were repaired with the hallux osteo-onychocutaneous flap, and 1 case (1 finger) was repaired with the hallux nail flap. All the reconstructed fingers survived uneventfully, and the recipient site healed primarily, and the donor site healed after dressing change, without infection and other complications. All the 8 patients (9 fingers) were followed up for 3-7 months. The nail plate of the donor site naturally grew and recovered nearly normal. Depression formation was observed at part of the deck junction of the recipient site, and scars were left in the pulp and fibular side of the hallux. At the final follow-up, the reconstructed fingers recovered protective sensation and tactile sense, and the 2PD of the reconstructed fingers was 9 mm and 10 mm in two cases. The SWM score was 3.60-4.31, mean 3.96. The results were the monofilament specifications and indicating the protective sensation was diminished. Functional evaluation of reconstructed fingers: 9 fingers in 8 cases scored 13-14 points, all reaching an excellent level. All patients were satisfied with the surgical results.Conclusion:Based on the concept and technology of full reconstruction, the fingertip defects of the thumb and finger can recover close to normal with the hallux tissue flap in the short-term, while ensuring the overall shape and function of the hallux donor area, achieving a balance between the donor and recipient areas, and achieving satisfactory clinical results.

Objective:To explore the application effect of microsurgical thinning optimized anterolateral thigh flap in the repair of limb tumor wounds.Methods:A retrospective analysis was conducted on the clinical data of patients with limb tumors at the Microsurgery and Reconstruction Department of Xuzhou Renci Hospital from January 2019 to January 2021. All patients underwent surgical resection of the lesions and were repaired with microsurgical thinning optimized anterolateral thigh flap. The outpatient follow-up was conducted after surgery. One year after surgery, limb function and appearance were evaluated using the Musculoskeletal Tumor Society (MSTS) bone tumor limb salvage surgery limb energy scale and efficacy satisfaction score. The total score is 30 points, and a higher score indicates better function. The limb appearance was evaluated using a satisfaction score scale, with a total score of 5-10 points being satisfactory, 0-4 points being average, and -5 to -1 points considered unsatisfactory. Descriptive methods were used for statistical analysis, and normally distributed measurement data were expressed as Mean±SD.Results:A total of 11 patients were included, comprising 7 males and 4 females, aged between 19 and 55 years, with an average age of 31.5 years. Among them, there were 3 cases of dermatofibrosarcoma protuberans, 4 cases of invasive fibroma, 1 case of mucinous fibrosarcoma, 2 cases of malignant fibrous histiocytoma, and 1 case of squamous cell carcinoma of the skin. The tumor lesion ranged from 5.5 cm × 8.0 cm to 9.0 cm × 19.0 cm, and the tumor resection range during surgery was from 6.5 cm × 9.0 cm to 10.0 cm × 20.0 cm. The size of the skin flap ranged from 7.5 cm × 11.0 cm to 10.0 cm × 22.5 cm. The average thickness of the flap before thinning was 2.2 cm (1.6-3.5 cm), and the average thickness after thinning was 1.2 cm (0.9-1.7 cm). One case of superficial necrosis occurred at the edge of the flap measuring 1.5 cm × 2.0 cm after surgery, and the wound healed after dressing changes. One case of arterial crisis occurred 48 hours after surgery, and thrombus formation was detected at the distal end of the anastomosis during exploration. After reanastomosis, blood flow was restored. The remaining flaps survived well, and the incisions healed in one stage. The average postoperative follow-up period was 14.5 months (12-18 months) with no tumor recurrence. The MSTS score for limb function was (25.2±2.1) points, and the satisfaction score for limb appearance efficacy was (7.4±1.6) points, with a satisfaction rate of 10 out of 11.Conclusion:The application of microsurgical thinning optimized anterolateral thigh flap in the plastic surgery of limb tumors can restore satisfactory limb function and appearance, making it an ideal surgical method.

Objective:To analyze the international status and level of clinical trial quality in China, and explore the advantages and value of scientific regulation of clinical research quality in China.Methods:The data is sourced from the relevant reports publicly released by the National Medical Products Administration (NMPA), the inspection reports and announcements published by the Center for Food and Drug Inspection of the NMPA, the inspection data displayed on the official website of the U.S. Food and Drug Administration (FDA), as well as clinical diagnosis and treatment guidelines issued by the National Comprehensive Cancer Network (NCCN) of United States and the Chinese Society of Clinical Oncology (CSCO) (data as of July 21, 2023). This data provides an analysis of the regulatory status of the implementation of clinical drug trials in China, inspection data, and the approval and market entry of new oncology drugs and feedback from their practical application.Results:The clinical trial quality inspection systems of China and the United States are generally aligned, with similar inspection subjects, focus areas, and public disclosure pathways. However, each has its characteristics in terms of inspection targets and types. The quality of clinical trial data in China has been continuously improving. Between 2009-2015 and 2016-July 2023, China underwent 25 and 20 FDA Bioresearch Monitoring (BIMO) inspections, respectively. The inspection results showing "No Action Indicated" (NAI) improved from 48.0% to 85.0%, while "Voluntary Action Indicated" (VAI) decreased from 44.0% to 15.0%. Official Action Indicated (OAI) measures were required in 2009 and 2012. Compared to the 2009-2015 period, there has been a clear upward trend in the quality of clinical trial data since 2016. From 2016 to July 2023, the number of new oncology drugs developed by Chinese pharmaceutical companies and included in professional guidelines has steadily increased. Specifically, 37 drugs (58.7%) were included in the 2022 edition of the CSCO guidelines, and 15 drugs (23.8%) were included in the 2023 edition of the NCCN guidelines, with 10 of these drugs featured in both guidelines.Conclusions:The implementation quality of clinical trials in China has gained a certain level of international recognition and competitiveness. This progress is attributed to national macro-level guidance, a unique institutional model, and clinical practices aligned with international standards. In the future, it will be necessary to further strengthen the scientific regulatory system and enhance clinical research capabilities to continue advancing the high-quality development of clinical trials.

Objective:To investigate the clinical efficacy of reconstruction with the hallux tissue flap for the fingertip defects of thumb and fingers based on the concept and technique of full reconstruction.Methods:From September 2022 to February 2023, the patients with thumb and fingertip defects who were reconstructed using the concept and technology of full reconstruction in Xuzhou Renci Hospital were respective analysised. Based on the degree of defect in the nail bed, bone, and soft tissue of the hand, a hallux osteo-onychocutaneous flap or hallux nail flap was designed and harvested from the same side of the toe, and free transplantation was performed to reconstruct the damaged fingertip. The wounds in the donor site that could not be sutured primarily were treated with dressing change. The surgical complications, the appearance of the reconstructed finger and donor site, Semmes-Weinstein monofilament (SWM) examination, 2-point discrimination (2PD) measurement, and patient satisfaction were regularly recorded. According to the functional evaluation criteria for thumb and finger reconstruction issued by the Hand Surgery of the Chinese Medical Association, the function of the reconstructed fingers was evaluated as excellent (13-15 points), good (9-12 points), fair (5-8 points), and poor (≤4 points). The patients were investigated whether they were satisfied with the outcomes.Results:A total of 8 patients (9 fingers) including 5 males and 3 females were enrolled. The average age was 32.4 years (range, 22-46 years). There were 1 thumb, 2 index fingers, 5 middle fingers, and 1 ring finger. 7 cases (8 fingers) were repaired with the hallux osteo-onychocutaneous flap, and 1 case (1 finger) was repaired with the hallux nail flap. All the reconstructed fingers survived uneventfully, and the recipient site healed primarily, and the donor site healed after dressing change, without infection and other complications. All the 8 patients (9 fingers) were followed up for 3-7 months. The nail plate of the donor site naturally grew and recovered nearly normal. Depression formation was observed at part of the deck junction of the recipient site, and scars were left in the pulp and fibular side of the hallux. At the final follow-up, the reconstructed fingers recovered protective sensation and tactile sense, and the 2PD of the reconstructed fingers was 9 mm and 10 mm in two cases. The SWM score was 3.60-4.31, mean 3.96. The results were the monofilament specifications and indicating the protective sensation was diminished. Functional evaluation of reconstructed fingers: 9 fingers in 8 cases scored 13-14 points, all reaching an excellent level. All patients were satisfied with the surgical results.Conclusion:Based on the concept and technology of full reconstruction, the fingertip defects of the thumb and finger can recover close to normal with the hallux tissue flap in the short-term, while ensuring the overall shape and function of the hallux donor area, achieving a balance between the donor and recipient areas, and achieving satisfactory clinical results.

Objective:To explore the application effect of microsurgical thinning optimized anterolateral thigh flap in the repair of limb tumor wounds.Methods:A retrospective analysis was conducted on the clinical data of patients with limb tumors at the Microsurgery and Reconstruction Department of Xuzhou Renci Hospital from January 2019 to January 2021. All patients underwent surgical resection of the lesions and were repaired with microsurgical thinning optimized anterolateral thigh flap. The outpatient follow-up was conducted after surgery. One year after surgery, limb function and appearance were evaluated using the Musculoskeletal Tumor Society (MSTS) bone tumor limb salvage surgery limb energy scale and efficacy satisfaction score. The total score is 30 points, and a higher score indicates better function. The limb appearance was evaluated using a satisfaction score scale, with a total score of 5-10 points being satisfactory, 0-4 points being average, and -5 to -1 points considered unsatisfactory. Descriptive methods were used for statistical analysis, and normally distributed measurement data were expressed as Mean±SD.Results:A total of 11 patients were included, comprising 7 males and 4 females, aged between 19 and 55 years, with an average age of 31.5 years. Among them, there were 3 cases of dermatofibrosarcoma protuberans, 4 cases of invasive fibroma, 1 case of mucinous fibrosarcoma, 2 cases of malignant fibrous histiocytoma, and 1 case of squamous cell carcinoma of the skin. The tumor lesion ranged from 5.5 cm × 8.0 cm to 9.0 cm × 19.0 cm, and the tumor resection range during surgery was from 6.5 cm × 9.0 cm to 10.0 cm × 20.0 cm. The size of the skin flap ranged from 7.5 cm × 11.0 cm to 10.0 cm × 22.5 cm. The average thickness of the flap before thinning was 2.2 cm (1.6-3.5 cm), and the average thickness after thinning was 1.2 cm (0.9-1.7 cm). One case of superficial necrosis occurred at the edge of the flap measuring 1.5 cm × 2.0 cm after surgery, and the wound healed after dressing changes. One case of arterial crisis occurred 48 hours after surgery, and thrombus formation was detected at the distal end of the anastomosis during exploration. After reanastomosis, blood flow was restored. The remaining flaps survived well, and the incisions healed in one stage. The average postoperative follow-up period was 14.5 months (12-18 months) with no tumor recurrence. The MSTS score for limb function was (25.2±2.1) points, and the satisfaction score for limb appearance efficacy was (7.4±1.6) points, with a satisfaction rate of 10 out of 11.Conclusion:The application of microsurgical thinning optimized anterolateral thigh flap in the plastic surgery of limb tumors can restore satisfactory limb function and appearance, making it an ideal surgical method.