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

NCT04466046 | Completed

• 1 other identifier: 19-100
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• postoperative pain

  48 hours after surgery

Study Arms (2)

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

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daegu Catholic University Medical Center: lead

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, Nam-gu, 42472, South Korea

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Jung A Lim, MD

  Daegu Catholic University Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 10, 2020
• Study Start: September 4, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)