Journal of pain research · 2025
Opioid-Free Anesthesia Alleviates Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy: Study Protocol for a Randomized, Controlled Trial.
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Li Ying, Hao Dandan, Qi Xiuru, Song Bijia
Аннотация
INTRODUCTION: Postoperative nausea and vomiting (PONV) remains a prevalent complication following laparoscopic cholecystectomy, often linked to perioperative opioid use. This randomized controlled trial aims to evaluate the efficacy of opioid-free anesthesia (OFA) in reducing PONV incidence and improving postoperative recovery quality compared to conventional opioid-based anesthesia (OBA).
METHODS/ANALYSIS: This study is a prospective randomized, controlled clinical trial with a concealed allocation of patients scheduled to undergo elective laparoscopic cholecystectomy 1:1 to receive either a standard anesthesia protocol or an OFA. A total of 96 patients were recruited in the study. Primary outcomes include the Rhodes Index of Nausea and Vomiting and the incidence of nausea and vomiting at 6 and 24 hours postoperatively.
ETHICS AND DISSEMINATION: This trial has been approved by the Institutional Review Board of Beijing Friendship Hospital of China Capital University. The trial study protocol was approved on April 16, 2025, with an anticipated patient recruitment period of 12 months. The ethical approval number was BFHHZS20250091. The trial started recruiting patients after registered on the Chinese Clinical Trial Registry.
TRIAL REGISTRATION NUMBER: CTR2500102278; Pre-results.
METHODS/ANALYSIS: This study is a prospective randomized, controlled clinical trial with a concealed allocation of patients scheduled to undergo elective laparoscopic cholecystectomy 1:1 to receive either a standard anesthesia protocol or an OFA. A total of 96 patients were recruited in the study. Primary outcomes include the Rhodes Index of Nausea and Vomiting and the incidence of nausea and vomiting at 6 and 24 hours postoperatively.
ETHICS AND DISSEMINATION: This trial has been approved by the Institutional Review Board of Beijing Friendship Hospital of China Capital University. The trial study protocol was approved on April 16, 2025, with an anticipated patient recruitment period of 12 months. The ethical approval number was BFHHZS20250091. The trial started recruiting patients after registered on the Chinese Clinical Trial Registry.
TRIAL REGISTRATION NUMBER: CTR2500102278; Pre-results.