Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery

Phase 4

Not yet recruiting

• Conditions: Postoperative Nausea; Vomiting
• Interventions: Drug: Aprepitant; Drug: Granisetron

• Registration Number: NCT05632224
• Lead Sponsor: Baskent University

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.

Detailed Description

The aim of this study is to investigate the effectiveness of drugs used for postoperative nausea and vomiting in laparoscopic surgeries.

In the research; During the operation, the patient's vitals will be recorded intraoperative forms. Vitals are; heart rate, blood pressure, oxygen saturation, end tidal carbon dioxide levels; according to the pain level after awakening from the patient follow-up forms in the service.

The doses and times of analgesics will be screened, the frequencies of postoperative nausea, retching, vomiting, and additional antiemetic doses will be screened, respiratory depression, complications of anesthesia, arrhythmia, laryngospasm, hypo-hypertension, headache, dizziness, allergic reactions anxiety symptoms will be screened too.

we will try to emphasize which antiemetic is more effective than the other and which one has few side effects

Study Timeline

• Study First Submitted: 2022-10-27
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-18
• Last Update Submitted: 2022-11-18
• Study Start: 2022-11-24
• Study First Posted: 2022-11-30
• Last Update Posted: 2022-11-30
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA I, II patients patients undergoing laparoscopic surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aprepitant	Aprepitant	Substance P inhibitor chemotherapeutic and also useable for prevention of postoperative nausea and vomiting
Granisetron	Granisetron	5- HT3( 5-hydroksitriptamine 3) antagonist drug for prevention of postoperative nausea and vomiting

Primary Outcome Measures

Name	Time	Method
the need for additional antiemetics	postoperative 24 hours	the need for additional antiemetics between 0-6 and 6-24 hours postoperatively
incidence of vomiting	postoperative 24 hours	the incidence of vomiting between 0-6 and 6-24 hours postoperatively
incidence of nausea	postoperative 24 hours	the incidence of nausea between 0-6 and 6-24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
additional analgesic need	postoperative 24 hours	Detection of additional analgesic needs between 0-6 and 6-24 hours postoperatively.
detection of complications	postoperative 24 hours	detection of complications between 0-6 and 6-24 hours postoperatively.

Trial Locations

Locations (1)

Baskent University Ankara Hospital; 🇹🇷 Ankara, Turkey