Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery

Vomiting Clinical Trial

— PONV  

Official title:

Retrospective Comparison of the Effects of Granisetron and Aprepitant in the Prevention of Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05632224
• Other study ID #: KA22/252
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 24, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: November 2022
• Source: Baskent University
• Contact: Begüm Ne Gökdemir, MD
• Phone: +905389598290
• Email: begokdemir[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• ASA I, II patients patients undergoing laparoscopic surgery

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Aprepitant
The drug is given 1 hour before the start of the surgery
• Granisetron
The drug is given 10 minutes before the patients's extubation

Locations

Country	Name	City	State
Turkey	Baskent University Ankara Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of nausea	the incidence of nausea between 0-6 and 6-24 hours postoperatively	postoperative 24 hours
Primary	the need for additional antiemetics	the need for additional antiemetics between 0-6 and 6-24 hours postoperatively	postoperative 24 hours
Primary	incidence of vomiting	the incidence of vomiting between 0-6 and 6-24 hours postoperatively	postoperative 24 hours
Secondary	additional analgesic need	Detection of additional analgesic needs between 0-6 and 6-24 hours postoperatively.	postoperative 24 hours
Secondary	detection of complications	detection of complications between 0-6 and 6-24 hours postoperatively.	postoperative 24 hours