The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in High Risk Patients

The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy

Nausea and vomiting after surgery are one of the complications that occur after general anesthesia, and the frequency is reported to range from 10% to 80% in the high-risk group. Several studies have introduced drugs and methods to prevent nausea and vomiting after surgery. Among them, midazolam administered before surgery is known to have anti-anxiolytic and sedative effects on the prevention of nausea and vomiting after surgery. It has also been reported to increase its effectiveness when administered with other antiemetic agents.

The purpose of this study is to compare the effects of administration of combination with midazolam and different antiemetic agents on the prevention of postoperative nausea and vomiting in high-risk patients.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting

Detailed Description

This prospective study evaluates female, nonsmoking patients undergoing laparoscopic cholecystectomy. The patients are divided into those with and without postoperative nausea and vomiting. The purpose of this study is to compare and observe the effect of administration of midazolam and two different antiemetics on prevention of postoperative nausea and vomiting.

0.05mg/kg of midazolam is administered intravenously 10 minutes before surgery as a pretreatment. 0.3mg ramosetron is administered intravenously right before the end of surgery and 0.075mg palonosetron is administered intravenously immediately after induction of anesthesia. The incidence of PONV, severity of nausea, use of rescue antiemetics, and pain severity was evaluated at 2 hours, 24hours, and 48 hours after surgery.

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• Korea, Republic of
  • Nam-gu
    • Daegu, Nam-gu, Korea, Republic of, 42472
      • Daegu Catholic University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

female patients aged 20 to 65 with ASA physical status 1 or 2 undergoing laparoscopic cholecystectomy

Description

Inclusion Criteria:

• 20-65 years old with American Society of Anesthesiologists (ASA) physical status 1-2 and scheduled for laparoscopic cholecystectomy.

Exclusion Criteria:

• pregnant or breast feeding patients
• smokers
• patients with history of chronic opioid abuse
• hypersensitivity to 5-HT3 receptor antagonists or analgesics
• those who were antiemetic or opioid treatment within 24 hours prior to surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PONV group; Patients with PONV after administration of midazolam 0.05mg/kg with ramosetron 0.3mg or palonosetron 0.075mg
no PONV group; Patients with no PONV after administration of midazolam 0.05mg/kg with ramosetron 0.3mg or palonosetron 0.075mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of patients receiving ramosetron or palonosetron in each groups	percentage of patients receiving ramosetron or palonosetron	48 hours after surgery
severity of postoperative nausea in PONV group	0 = none, 1 = mild, 2 = moderate, 3 = severe	48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	numerical analog scale : 0 to 10	48 hours after surgery

Collaborators and Investigators

• Sponsor: Daegu Catholic University Medical Center
• Investigators: Study Chair: Jung A Lim, MD, Daegu Catholic University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 19-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No