Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery

NCT05632224 | Unknown Phase 4

• 1 other identifier: KA22/252
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare frequency with postoperative nausea and vomiting in ASA( American Society of Anesthesiologists) I, II patients undergoing laparoscopic surgery. The main question\[s\] it aims to answer are:

• Primary Outcome is the incidence of nausea and vomiting between 0-6 and 6-24 hours postoperatively and the need for additional antiemetics
• Secondary outcome is detection of additional analgesic needs and complications between 0-6 and 6-24 hours postoperatively. Participants will receive aprepitant or granisetron for prevention of postoperative nausea and vomiting.

Conditions

Postoperative Nausea; Vomiting

Keywords

postoperative nausea and vomiting; laparoscopic surgery

Outcome Measures

Primary Outcomes (3)

• incidence of nausea

  the incidence of nausea between 0-6 and 6-24 hours postoperatively

  postoperative 24 hours

• the need for additional antiemetics

  the need for additional antiemetics between 0-6 and 6-24 hours postoperatively

  postoperative 24 hours

• incidence of vomiting

  the incidence of vomiting between 0-6 and 6-24 hours postoperatively

  postoperative 24 hours

Secondary Outcomes (2)

• additional analgesic need

  postoperative 24 hours

• detection of complications

  postoperative 24 hours

Study Arms (2)

Aprepitant

ACTIVE COMPARATOR

Substance P inhibitor chemotherapeutic and also useable for prevention of postoperative nausea and vomiting

Drug: Aprepitant

Granisetron

ACTIVE COMPARATOR

5- HT3( 5-hydroksitriptamine 3) antagonist drug for prevention of postoperative nausea and vomiting

Drug: Granisetron

Interventions

Aprepitant DRUG

The drug is given 1 hour before the start of the surgery

Also known as: Emend

Aprepitant

Granisetron DRUG

The drug is given 10 minutes before the patients's extubation

Also known as: Sinarex

Granisetron

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I, II patients patients undergoing laparoscopic surgery

You may not qualify if:

• ASA III and above patients who refused to participate in the study

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University Ankara Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Vomiting

Interventions

Aprepitant; Granisetron

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Begüm Ne Gökdemir, MD

CONTACT

+905389598290; begokdemir@gmail.com

Nedim Çekmen, Professor

CONTACT

+905307384682; nedimcekmen@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: group 1:patient who receive aprepitant group 2: patient who receive granisetron

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 30, 2022
• Study Start: November 24, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)