Clinical Trials Logo

Clinical Trial Summary

This trial aims to explore whether the intraoperative use of remimazolam can reduce the incidence of postoperative nausea and vomiting (PONV) in high-risk patients. According to the Apfel's simplified score, patients with 3 or more of the following factors are at high risk of postoperative nausea and vomiting (PONV), i.e., women, non-smokers, history of PONV, and postoperative use of opioids.


Clinical Trial Description

Postoperative nausea and vomiting (PONV) is a common adverse event after general anesthesia. The incidence of PONV within 2 hours after surgery was approximately 14% in patients undergoing laparoscopic gynecological procedure and it could be about 22%-33% within 24 hours and as high as 80% in high-risk patients. Even with prophylaxis and treatment, such as 5-hydroxytryptamine 3 (5-HT3) receptor antagonists, the incidence of PONV is still about 7%-10%. PONV is an important clinical problem that impact the recovery of patients. Firstly, it can be a highly distress experience to patients and reduce their satisfaction with medical services. Secondly, PONV is associated with prolonged stay in the postanesthesia care unit and hospital, and increase medical expenditures. Thirdly, PONV increases the risk of reflux aspiration and lung infection. Risk factors for PONV in adults include anxiety, opioid use, and inflammation. A cohort study showed that patients with anxiety before surgery have a 5-fold increase in the risk of PONV. Opioids are one of the main causes of PONV, and the incidence of PONV increases with the increasing dose of opioids. Inflammation is also considered to be a potential molecular mechanism leading to PONV. Animal studies have shown that surgery can cause inflammation throughout the body and central nervous system, and stimulate the "vomiting center" , which leads to PONV. Several clinical studies reported that midazolam decreased PONV. In a meta-analysis included 12 randomized trials (841 patients), the use of midazolam during the perioperative period reduced the risk of PONV by about 55%. Another Meta-analysis involving 16 randomized controlled studies also reported similar results. The use of midazolam during the perioperative period reduced the risk of PONV by approximately 45%. The mechanism by which benzodiazepines reduce PONV is not fully understood, but may include the following. Benzodiazepines can reduce the incidence of anxiety and reduce the severity of anxiety. On the other hand, studies have shown that the use of remimazolam enhances the analgesic effect of remifentanil and may reduce the dose of opioids. Another aspect is benzodiazepines may suppress the inflammatory response. Remimazolam is an ultra-short-acting benzodiazepine sedative. It has a more predictable fast onset, short duration of sedative action, and rapid recovery profile, but there is no clinical study on whether remimazolam has an effect on the incidence of PONV. The investigators speculate that remimazolam as a supplement anesthetic during general anesthesia can reduce the incidence of PONV. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04861337
Study type Interventional
Source Peking University First Hospital
Contact Dong-Liang Mu, MD
Phone 010-83475138
Email [email protected]
Status Not yet recruiting
Phase Phase 4
Start date April 2021
Completion date November 2021

See also
  Status Clinical Trial Phase
Completed NCT04466046 - The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in High Risk Patients N/A
Completed NCT03139383 - Dextrose Containing Fluid and the Postoperative Nausea and Vomiting in the Gynecologic Laparoscopic Surgery N/A
Recruiting NCT04069806 - Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section N/A
Completed NCT04043247 - Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting N/A
Terminated NCT01975727 - Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting Phase 2
Completed NCT03662672 - Rib Raising for Post-operative Ileus N/A
Completed NCT00090155 - 2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED) Phase 3
Completed NCT02480088 - Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery; Association With ABCB1 Polymorphism Phase 4
Completed NCT02944942 - Risk Factors for Postoperative Nausea/Vomiting N/A
Recruiting NCT02571153 - Low Doses of Ketamine and Postoperative Quality of Recovery Phase 4
Completed NCT02449291 - Study of APD421 as PONV Treatment (no Prior Prophylaxis) Phase 3
Completed NCT02550795 - Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer N/A
Recruiting NCT01442012 - Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting in Ambulatory Surgery N/A
Completed NCT01478165 - Comparison of TIVA (Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing Postoperative Nausea and Vomiting N/A
Unknown status NCT01268748 - Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain N/A
Completed NCT02143531 - Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting Phase 4
Completed NCT00734929 - Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy Phase 4
Withdrawn NCT00151099 - Safety of Preoperative Oral Administration of a High Caloric Drink With Protein Phase 4
Completed NCT03641625 - Effect of SmtO2 Guided Care on PONV (iMODIPONV) N/A
Recruiting NCT04110080 - Enhanced Recovery After Surgery in Kidney Transplant Donors N/A