Effects of opioid-free anaesthesia on postoperative nausea and vomiting in patients undergoing video-assisted thoracoscopic surgery (OFA-PONV trial): study protocol for a randomised controlled trial

被引:1
作者
Yan, Xiang [1 ]
Liang, Chen [2 ]
Jiang, Jia [1 ]
Ji, Ying [3 ]
Wu, Anshi [1 ]
Wei, Changwei [1 ]
机构
[1] Capital Med Univ, Beijing ChaoYang Hosp, Dept Anaesthesiol, 8 Gongren Tiyuchang Nanlu, Beijing, Peoples R China
[2] Medieco Grp Co Ltd, Dept Med Stat, Beijing, Peoples R China
[3] Capital Med Univ, Beijing ChaoYang Hosp, Dept Thorac Surg, Beijing, Peoples R China
关键词
Anaesthesia; Opioid; Nausea; Vomiting; Video-assisted; Surgery; PARAVERTEBRAL BLOCK; SCORE; GUIDELINES; STATEMENT; RECOVERY;
D O I
10.1186/s13063-023-07859-z
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
BackgroundPostoperative nausea and vomiting (PONV) is a common complication after general anaesthesia and is associated with morbidity and prolonged length of stay. Growing evidence suggest that opioid-free general anaesthesia (OFA) may reduce PONV in various surgical settings. We aim to evaluate the efficacy of OFA on the incidence of PONV compared with opioid-based anaesthesia among adults undergoing thoracoscopic surgery.MethodsThis is a prospective, single-centre, randomised controlled trial comparing OFA and opioid-based anaesthesia for thoracoscopic surgery. A total of 168 adults will be randomised with a 1:1 ratio to receive either opioid-free anaesthesia or opioid-based anaesthesia. The primary outcome will be the incidence of PONV within 24 h after operation. The secondary outcomes will include the severity of PONV, quality of recovery, pain at rest, 6-min walking test, and health-related quality of life after operation.DiscussionThe benefit-risk of OFA for patients after operation is contradictory in previous studies, so further study is required. This trial will focus on the effect of OFA on the incidence of PONV in patients undergoing thoracoscopic surgery. This trial adopts uniformed PONV and perioperative pain management, standardised randomised and blind, clear-cut inclusion and exclusion criteria, and standardised scales to assess the severity of PONV after surgery, the quality of postoperative recovery, and the health status at 6 months. The findings of this study will help to provide references to promote early recovery of patients after lung surgery.Trial registrationClinicalTrials.gov NCT05411159. Registered on 9 June 2022.
引用
收藏
页数:8
相关论文
共 29 条
[1]   THE POSTANESTHESIA RECOVERY SCORE REVISITED [J].
ALDRETE, JA .
JOURNAL OF CLINICAL ANESTHESIA, 1995, 7 (01) :89-91
[2]   Opioid-free anesthesia compared to opioid anesthesia for lung cancer patients undergoing video-assisted thoracoscopic surgery: A randomized controlled study [J].
An, Guangquan ;
Zhang, Yiwen ;
Chen, Nuoya ;
Fu, Jianfeng ;
Zhao, Bingsha ;
Zhao, Xuelian .
PLOS ONE, 2021, 16 (09)
[3]   Evidence-based analysis of risk factors for postoperative nausea and vomiting [J].
Apfel, C. C. ;
Heidrich, F. M. ;
Jukar-Rao, S. ;
Jalota, L. ;
Hornuss, C. ;
Whelan, R. P. ;
Zhang, K. ;
Cakmakkaya, O. S. .
BRITISH JOURNAL OF ANAESTHESIA, 2012, 109 (05) :742-753
[4]   A simplified risk score for predicting postoperative nausea and vomiting -: Conclusions from cross-validations between two centers [J].
Apfel, CC ;
Läärä, E ;
Koivuranta, M ;
Greim, CA ;
Roewer, N .
ANESTHESIOLOGY, 1999, 91 (03) :693-700
[5]   Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS®) Society and the European Society of Thoracic Surgeons (ESTS) [J].
Batchelor, Timothy J. P. ;
Rasburn, Neil J. ;
Abdelnour-Berchtold, Etienne ;
Brunelli, Alessandro ;
Cerfolio, Robert J. ;
Gonzalez, Michel ;
Ljungqvist, Olle ;
Petersen, Rene H. ;
Popescu, Wanda M. ;
Slinger, Peter D. ;
Naidu, Babu .
EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY, 2019, 55 (01) :91-115
[6]   SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials [J].
Chan, An-Wen ;
Tetzlaff, Jennifer M. ;
Altman, Douglas G. ;
Laupacis, Andreas ;
Gotzsche, Peter C. ;
Krleza-Jeric, Karmela ;
Hrobjartsson, Asbjorn ;
Mann, Howard ;
Dickersin, Kay ;
Berlin, Jesse A. ;
Dore, Caroline J. ;
Parulekar, Wendy R. ;
Summerskill, William S. M. ;
Groves, Trish ;
Schulz, Kenneth F. ;
Sox, Harold C. ;
Rockhold, Frank W. ;
Rennie, Drummond ;
Moher, David .
ANNALS OF INTERNAL MEDICINE, 2013, 158 (03) :200-+
[7]   ATS statement: Guidelines for the six-minute walk test [J].
Crapo, RO ;
Casaburi, R ;
Coates, AL ;
Enright, PL ;
MacIntyre, NR ;
McKay, RT ;
Johnson, D ;
Wanger, JS ;
Zeballos, RJ ;
Bittner, V ;
Mottram, C .
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 2002, 166 (01) :111-117
[8]   Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study [J].
Dell-Kuster, Salome ;
Gomes, Nuno, V ;
Gawria, Larsa ;
Aghlmandi, Soheila ;
Aduse-Poku, Maame ;
Bissett, Ian ;
Blanc, Catherine ;
Brandt, Christian ;
ten Broek, Richard B. ;
Bruppacher, Heinz R. ;
Clancy, Cillian ;
Delrio, Paolo ;
Espin, Elo ;
Galanos-Demiris, Konstantinos ;
Gecim, Ethem ;
Ghaffari, Shahbaz ;
Gie, Olivier ;
Goebel, Barbara ;
Hahnloser, Dieter ;
Herbst, Friedrich ;
Orestis, Ioannidis ;
Joller, Sonja ;
Kang, Soojin ;
Martin, Rocio ;
Mayr, Johannes ;
Meier, Sonja ;
Murugesan, Jothi ;
Nally, Deirdre ;
Ozcelik, Menekse ;
Pace, Ugo ;
Passeri, Michael ;
Rabanser, Simone ;
Ranter, Barbara ;
Rega, Daniela ;
Ridgway, Paul F. ;
Rosman, Camie ;
Schmid, Roger ;
Schumacher, Philippe ;
Solis-Pena, Alejandro ;
Villarino, Laura ;
Vrochides, Dionisios ;
Engel, Alexander ;
O'Grady, Greg ;
Loveday, Benjamin ;
Steiner, Luzius A. ;
Van Goor, Harry ;
Bucher, Heiner C. ;
Clavien, Pierre-Alain ;
Kirchhoff, Philipp ;
Rosenthal, Rachel .
BMJ-BRITISH MEDICAL JOURNAL, 2020, 370
[9]   Classification of surgical complications - A new proposal with evaluation in a cohort of 6336 patients and results of a survey [J].
Dindo, D ;
Demartines, N ;
Clavien, PA .
ANNALS OF SURGERY, 2004, 240 (02) :205-213
[10]   Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis [J].
Frauenknecht, J. ;
Kirkham, K. R. ;
Jacot-Guillarmod, A. ;
Albrecht, E. .
ANAESTHESIA, 2019, 74 (05) :651-662