Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery (PONV)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vomiting; Postoperative Nausea
• Intervention / Treatment: Drug: Aprepitant; Drug: Granisetron

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Begüm Ne Gökdemir, MD; Phone Number: +905389598290; Email: begokdemir@gmail.com
• Study Contact Backup: Name: Nedim Çekmen, Professor; Phone Number: +905307384682; Email: nedimcekmen@yahoo.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Baskent University Ankara Hospital
    • Contact: Nedim Çekmen, Professor;MD; Phone Number: +905307384682; Email: nedimcekmen@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aprepitant; Substance P inhibitor chemotherapeutic and also useable for prevention of postoperative nausea and vomiting	Drug: Aprepitant; The drug is given 1 hour before the start of the surgery; Other Names: Emend
Active Comparator: Granisetron; 5- HT3( 5-hydroksitriptamine 3) antagonist drug for prevention of postoperative nausea and vomiting	Drug: Granisetron; The drug is given 10 minutes before the patients's extubation; Other Names: Sinarex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
additional analgesic need	Detection of additional analgesic needs between 0-6 and 6-24 hours postoperatively.	postoperative 24 hours
detection of complications	detection of complications between 0-6 and 6-24 hours postoperatively.	postoperative 24 hours

Collaborators and Investigators

• Sponsor: Baskent University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 24, 2022
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: laparoscopic surgery; postoperative nausea and vomiting
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Neurokinin-1 Receptor Antagonists; Granisetron; Aprepitant
• Other Study ID Numbers: KA22/252

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
• product manufactured in and exported from the U.S.: No