Effect of Remimazolam on Postoperative Nausea and Vomiting

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

Sponsors

Lead Sponsor: Inje University

Source Inje University
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-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.

Overall Status Recruiting
Start Date 2022-04-13
Completion Date 2024-04-12
Primary Completion Date 2024-04-12
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
postoperative nausea and vomit within 24 hours after the end of operation Upto 24 hours after surgery
Secondary Outcome
Measure Time Frame
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
Enrollment 108
Condition
Intervention

Intervention Type: Drug

Intervention Name: Remimazolam (Byfavo)

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

Arm Group Label: Remimazolam group

Intervention Type: Drug

Intervention Name: Control

Description: 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.

Arm Group Label: 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

Gender:

Female

Minimum Age:

19 Years

Maximum Age:

65 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
In-Jung Jun, MD.PhD. Principal Investigator Associate professor
Overall Contact

Last Name: In-Jung Jun

Phone: 82-10-9312-0162

Email: [email protected]

Location
Facility: Status: Contact: Sanggye Paik hospital In-Jung Jun 82-10-9312-0162 [email protected]
Location Countries

Korea, Republic of

Verification Date

2022-06-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Inje University

Investigator Full Name: In-Jung Jun

Investigator Title: associate professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Remimazolam group

Type: Experimental

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

Label: Control group

Type: Placebo Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Other

Masking: Double (Participant, Outcomes Assessor)

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