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Effect of Remimazolam on Postoperative Nausea and Vomiting

Sponsor
Inje University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05439057
Collaborator
(none)
108
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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-HT3 receptor antagonist is the most commonly used agent and other agents such as corticosteroid, NK1 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Effect of Remimazolam on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy
Actual Study Start Date :
Apr 13, 2022
Anticipated Primary Completion Date :
Apr 12, 2024
Anticipated Study Completion Date :
Apr 12, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Remimazolam (Byfavo)
Remimazolam is infused at a rate of 0.3 mg/kg/hr from induction of anesthesia until 20 minutes before the end of operation.
Placebo Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

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

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

    pain is evaluated using Numeric rating scale (NRS).

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sanggye Paik hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Inje University

Investigators

  • Principal Investigator: In-Jung Jun, MD.PhD., Associate professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
In-Jung Jun, associate professor, Inje University
ClinicalTrials.gov Identifier:
NCT05439057
Other Study ID Numbers:
  • 2022-03-007
First Posted:
Jun 30, 2022
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting

Study Results

No Results Posted as of Jun 30, 2022