Effect of Remimazolam on Postoperative Nausea and Vomiting

Last updated: June 14, 2025
Sponsor: Inje University
Overall Status: Completed

Phase

N/A

Condition

Vomiting

Lactose Intolerance

Colic

Treatment

Control

Remimazolam

Clinical Study ID

NCT05439057
2022-03-007
  • Ages 19-65
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • women undergoing laparoscopic cholecystectomy under general anesthesia.

Exclusion

Exclusion Criteria:

  • moderate to severe liver dysfunction (total bilirubin ≧ 3.0 mg/dL / aspartateaminotransferase(AST) or alanine aminotransferase(ALT) ≧ 2.5 times more than normalrange)

  • moderate to severe renal dysfunction (serum creatinine ≧ 2.0 mg/dL / end-stage renaldisease 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

Study Design

Total Participants: 108
Treatment Group(s): 2
Primary Treatment: Control
Phase:
Study Start date:
April 13, 2022
Estimated Completion Date:
October 31, 2024

Study 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.

Connect with a study center

  • Sanggye Paik hospital

    Seoul,
    Korea, Republic of

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.