Effect of intraoperative noise isolation on postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery: protocol for a randomized controlled trial
Abstract Background Postoperative nausea and vomiting (PONV) are common complications following general anesthesia, particularly in gynecological laparoscopic surgeries. This study aims to evaluate the effect of intraoperative noise isolation on PONV incidence. Method This single-center, prospective...
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2025-01-01
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| Series: | BMC Anesthesiology |
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| Online Access: | https://doi.org/10.1186/s12871-025-02924-3 |
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| author | Chong Fu Fan Xia Zihan Yan Han-bing Xu Wei-ming Zhao Yi-shan Lei Chang Xu Wen-wen Huo Duo-duo Tao Juan Wang Xi-sheng Shan Ke Peng Hong Liu Fu-hai Ji Hua-yue Liu |
| author_facet | Chong Fu Fan Xia Zihan Yan Han-bing Xu Wei-ming Zhao Yi-shan Lei Chang Xu Wen-wen Huo Duo-duo Tao Juan Wang Xi-sheng Shan Ke Peng Hong Liu Fu-hai Ji Hua-yue Liu |
| author_sort | Chong Fu |
| collection | DOAJ |
| description | Abstract Background Postoperative nausea and vomiting (PONV) are common complications following general anesthesia, particularly in gynecological laparoscopic surgeries. This study aims to evaluate the effect of intraoperative noise isolation on PONV incidence. Method This single-center, prospective, randomized controlled trial will enroll 192 adult patients undergoing laparoscopic gynecological surgery. Patients will be randomly assigned in a 1:1 ratio and stratified by age into either the control group (Group C), without noise-cancelling headphones, or a noise reduction group (Group NR), using noise-cancelling headphones from anesthesia induction until the end of surgery. All patients will receive intraoperative dexamethasone and ondansetron prophylaxis. The primary outcome is the incidence of PONV within 48 h post-surgery. Secondary outcomes include PONV severity at 24 and 48 h, antiemetic use, pain scores, need for rescue analgesia, Quality of Recovery-15 (QoR-15) scores, Richards-Campbell Sleep Questionnaire (RCSQ) scores, hemodynamic interventions, extubation time, length of stay in PACU and hospital, adverse events (hypertension, hypotension, bradycardia, tachycardia, desaturation after extubation, postoperative shivering, emergence agitation, allergic reactions, severe arrhythmias arrhythmia, cardiac arrest, hypothermia), patient satisfaction, and postoperative complications based on the Postoperative Morbidity Survey (POMS). Analyses will be conducted using modified intention-to-treat (mITT) and per-protocol (PP) populations. Discussion We hypothesize that intraoperative use of noise-cancelling headphones will reduce PONV incidence in patients undergoing gynecological laparoscopic surgery. The findings could enhance postoperative care protocols for thoracoscopic gynecological procedures. Trial registration Chinese Clinical Trial Registry (ChiCTR2400087460). |
| format | Article |
| id | doaj-art-16cbd02c3b4f4f86b9b9ab36d53f93b7 |
| institution | Kabale University |
| issn | 1471-2253 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Anesthesiology |
| spelling | doaj-art-16cbd02c3b4f4f86b9b9ab36d53f93b72025-02-02T12:40:05ZengBMCBMC Anesthesiology1471-22532025-01-0125111010.1186/s12871-025-02924-3Effect of intraoperative noise isolation on postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery: protocol for a randomized controlled trialChong Fu0Fan Xia1Zihan Yan2Han-bing Xu3Wei-ming Zhao4Yi-shan Lei5Chang Xu6Wen-wen Huo7Duo-duo Tao8Juan Wang9Xi-sheng Shan10Ke Peng11Hong Liu12Fu-hai Ji13Hua-yue Liu14Department of Anesthesiology, First Affiliated Hospital of Soochow UniversityDepartment of Anesthesiology, First Affiliated Hospital of Soochow UniversitySuzhou Medical College, Soochow UniversityDepartment of Anesthesiology, First Affiliated Hospital of Soochow UniversityDepartment of Anesthesiology, First Affiliated Hospital of Soochow UniversityDepartment of Anesthesiology, First Affiliated Hospital of Soochow UniversityDepartment of Anesthesiology, First Affiliated Hospital of Soochow UniversityDepartment of Anesthesiology, First Affiliated Hospital of Soochow UniversityDepartment of Ear, Nose, and Throat, The First Affiliated Hospital of Soochow UniversityDepartment of Obstetrics and Gynecology, the First Affiliated Hospital of Soochow UniversityDepartment of Anesthesiology, First Affiliated Hospital of Soochow UniversityDepartment of Anesthesiology, First Affiliated Hospital of Soochow UniversityDepartment of Anesthesiology and Pain Medicine, University of California Davis HealthDepartment of Anesthesiology, First Affiliated Hospital of Soochow UniversityDepartment of Anesthesiology, First Affiliated Hospital of Soochow UniversityAbstract Background Postoperative nausea and vomiting (PONV) are common complications following general anesthesia, particularly in gynecological laparoscopic surgeries. This study aims to evaluate the effect of intraoperative noise isolation on PONV incidence. Method This single-center, prospective, randomized controlled trial will enroll 192 adult patients undergoing laparoscopic gynecological surgery. Patients will be randomly assigned in a 1:1 ratio and stratified by age into either the control group (Group C), without noise-cancelling headphones, or a noise reduction group (Group NR), using noise-cancelling headphones from anesthesia induction until the end of surgery. All patients will receive intraoperative dexamethasone and ondansetron prophylaxis. The primary outcome is the incidence of PONV within 48 h post-surgery. Secondary outcomes include PONV severity at 24 and 48 h, antiemetic use, pain scores, need for rescue analgesia, Quality of Recovery-15 (QoR-15) scores, Richards-Campbell Sleep Questionnaire (RCSQ) scores, hemodynamic interventions, extubation time, length of stay in PACU and hospital, adverse events (hypertension, hypotension, bradycardia, tachycardia, desaturation after extubation, postoperative shivering, emergence agitation, allergic reactions, severe arrhythmias arrhythmia, cardiac arrest, hypothermia), patient satisfaction, and postoperative complications based on the Postoperative Morbidity Survey (POMS). Analyses will be conducted using modified intention-to-treat (mITT) and per-protocol (PP) populations. Discussion We hypothesize that intraoperative use of noise-cancelling headphones will reduce PONV incidence in patients undergoing gynecological laparoscopic surgery. The findings could enhance postoperative care protocols for thoracoscopic gynecological procedures. Trial registration Chinese Clinical Trial Registry (ChiCTR2400087460).https://doi.org/10.1186/s12871-025-02924-3Postoperative nausea and vomitingPostoperative outcomesGynecological laparoscopic surgeryNoise isolation |
| spellingShingle | Chong Fu Fan Xia Zihan Yan Han-bing Xu Wei-ming Zhao Yi-shan Lei Chang Xu Wen-wen Huo Duo-duo Tao Juan Wang Xi-sheng Shan Ke Peng Hong Liu Fu-hai Ji Hua-yue Liu Effect of intraoperative noise isolation on postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery: protocol for a randomized controlled trial BMC Anesthesiology Postoperative nausea and vomiting Postoperative outcomes Gynecological laparoscopic surgery Noise isolation |
| title | Effect of intraoperative noise isolation on postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery: protocol for a randomized controlled trial |
| title_full | Effect of intraoperative noise isolation on postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery: protocol for a randomized controlled trial |
| title_fullStr | Effect of intraoperative noise isolation on postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery: protocol for a randomized controlled trial |
| title_full_unstemmed | Effect of intraoperative noise isolation on postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery: protocol for a randomized controlled trial |
| title_short | Effect of intraoperative noise isolation on postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery: protocol for a randomized controlled trial |
| title_sort | effect of intraoperative noise isolation on postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery protocol for a randomized controlled trial |
| topic | Postoperative nausea and vomiting Postoperative outcomes Gynecological laparoscopic surgery Noise isolation |
| url | https://doi.org/10.1186/s12871-025-02924-3 |
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