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Completed

NCT Number: NCT05439057

Effect of Remimazolam on Postoperative Nausea and Vomiting

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.

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Key information

Age range

19 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sanggye Paik hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam

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.

Other names: remimazolam group

Control

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.

Other names: control group

Primary outcomes

  1. postoperative nausea and vomit within 24 hours after the end of operation

    Time frame: Upto 24 hours after surgery

    Nausea is evaluated using 11-point verbal numeric rating scale (VNRS -none:0, mild: 1-3, moderate:4-6, severe 7-10). Vomiting is checked when the patient has vomited or has retching symptom.

Secondary outcomes

  1. quality of recovery (QoR-15) 24 hours after the end of the operation

    Time frame: Upto 24 hours after surgery

    QoR-15 survey is performed 24 hours after the end of the operation.

  2. pain 24 hours after the end of the operation

    Time frame: Upto 24 hours after surgery

    pain is evaluated using Numeric rating scale (NRS).

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

Effect of Remimazolam on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 30, 2022
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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