Effect of Remimazolam on Postoperative Nausea and Vomiting

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05439057
• Other study ID #: 2022-03-007
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2022
• Est. completion date: April 12, 2024

Study information

• Verified date: July 2023
• Source: Inje University
• Contact: In-Jung Jun
• Phone: 82-10-9312-0162
• Email: christine17[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: April 12, 2024
• Est. primary completion date: April 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Sanggye Paik hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	quality of recovery (QoR-15) 24 hours after the end of the operation	QoR-15 survey is performed 24 hours after the end of the operation.	Upto 24 hours after surgery
Secondary	pain 24 hours after the end of the operation	pain is evaluated using Numeric rating scale (NRS).	Upto 24 hours after surgery