NCT05439057

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

2.6 years

First QC Date

June 27, 2022

Last Update Submit

June 14, 2025

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

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

    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.

    Upto 24 hours after surgery

Secondary Outcomes (2)

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

    Upto 24 hours after surgery

  • pain 24 hours after the end of the operation

    Upto 24 hours after surgery

Study Arms (2)

Remimazolam group

EXPERIMENTAL

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

Drug: Remimazolam

Control group

PLACEBO COMPARATOR

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.

Drug: Control

Interventions

RemimazolamDRUG

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

Also known as: remimazolam group
Remimazolam group
ControlDRUG

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.

Also known as: control group
Control group

Eligibility Criteria

Age19 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women undergoing laparoscopic cholecystectomy under general anesthesia.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanggye Paik hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 40898019DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

remimazolamControl Groups

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • In-Jung Jun, MD.PhD.

    Associate professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 27, 2022

First Posted

June 30, 2022

Study Start

April 13, 2022

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

June 18, 2025

Record last verified: 2025-06

Locations

KR(1)