Effect of Remimazolam on Postoperative Nausea and Vomiting

NCT ID: NCT05439057

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-13
• Study Completion Date: 2024-10-31

Brief Summary

The present trial is to study the effect of low dose remimazolam on postoperative nausea and vomiting (PONV) in patients at risks of PONV (women, postoperative use of opioid, nonsmokers) undergoing laparoscopic cholecystectomy.

Detailed Description

Postoperative nausea and vomiting (PONV) is a common complication in patients undergoing general anesthesia. It is reported that PONV is observed in 50% of patients 24 hours after general anesthesia and upto 80% in high risk patients. The patients experiencing PONV may experience severe discomfort that it is important to prevent PONV. There are several prophylactic agents for PONV. 5 serotonin receptor antagonist(5-HT3 antagonist) is the most commonly used agent and other agents such as corticosteroid, neurokinin-1 receptor antagonist can also be used. Previous studies have reported the efficacy of benzodiazepine(midazolam) in a low targeting dose as a prophylactic agent of PONV. The efficacy of low dose remimazolam (short acting benzodiazepine) on PONV has not been evaluated.

According to Fourth consensus guideline for the management of postoperative nausea and vomiting (2020), three prophylactic anti-emetics are recommended for patients with three or more of the risk factors of PONV. As the patients included in our study have three or more of risk factors of PONV (women, postoperative use of opioid, nonsmokers), three prophylactic anti-emetics are recommended. Our center has routinely been using 5-HT3 receptor antagonist (ramosetron) and corticosteroid (dexamethasone) for women undergoing laparoscopic cholecystectomy. However, we still find many patients complaining nausea and vomiting after operation. Therefore, we are willing to investigate the low supplemental dose of remimazolam on the prophylaxis of PONV.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Remimazolam group

Remimazolam is started during induction of anesthesia at the rate of 0.3 mg/kg/hr and stopped 20 minutes before end of operation.

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

Remimazolam is infused at a rate of 0.3 mg/kg/hr from induction of anesthesia until 20 minutes before the end of operation.

Control group

0.9% normal saline is started during induction of anesthesia at the rate of 0.3 ml/kg/hr and stopped 20 minutes before end of operation.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DRUG

Normal saline is infused at a rate of 0.3 ml/kg/hr from induction of anesthesia until 20 minutes before the end of operation.

Interventions

Remimazolam

Remimazolam is infused at a rate of 0.3 mg/kg/hr from induction of anesthesia until 20 minutes before the end of operation.

Intervention Type: DRUG

Control

Normal saline is infused at a rate of 0.3 ml/kg/hr from induction of anesthesia until 20 minutes before the end of operation.

Intervention Type: DRUG

Other Intervention Names

remimazolam group; control group

Eligibility Criteria

Inclusion Criteria

• women undergoing laparoscopic cholecystectomy under general anesthesia.

Exclusion Criteria

• moderate to severe liver dysfunction (total bilirubin ≧ 3.0 mg/dL / aspartate aminotransferase(AST) or alanine aminotransferase(ALT) ≧ 2.5 times more than normal range)
• moderate to severe renal dysfunction (serum creatinine ≧ 2.0 mg/dL / end-stage renal disease undergoing hemodialysis)
• tolerance to benzodiazepines
• hypersensitivity to anesthetic drugs (Benzodiazepines, Propofol, Remifentanil, Fentanyl citrate, Rocuronium bromide, Flumazenil)
• acute angle glaucoma
• alcohol dependence
• Galactose intolerance, Lactase deficiency, glucose-galactose malabsorption
• pregnant, breast feeding women
• BMI >35 kg/m2
• uncontrolled diabetes mellitus

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Inje University

OTHER

Sponsor Role: lead

Responsible Party

In-Jung Jun

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In-Jung Jun, MD.PhD.

Role: PRINCIPAL_INVESTIGATOR

Associate professor

Locations

Sanggye Paik hospital

Seoul, , South Korea

Countries

South Korea

References

Park S, Yon JH, Lee S, Kim KM, Jun IJ. Efficacy of intraoperative low-dose remimazolam as a third antiemetic agent for preventing early postoperative nausea in high-risk patient: A Randomized controlled trial. BMC Anesthesiol. 2025 Sep 2;25(1):442. doi: 10.1186/s12871-025-03332-3.

Reference Type: DERIVED

PMID: 40898019 (View on PubMed)

Other Identifiers

2022-03-007

Identifier Type: -

Identifier Source: org_study_id