Gallbladder Removal Clinical Trials

Clinical trials related to Gallbladder Removal Procedure

Time-to-first-rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy: a Randomized, Triple-Blind, Superiority Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The goal of this superiority randomized controlled trial (RCT) is to learn if one dual-drug arm increases patient comfort (time to needing rescue medication for nausea/vomiting) more effectively than the other in adults with Moderate-to-High PONV risk (Apfel score 2-4) undergoing elective laparoscopic cholecystectomy (gallbladder surgery). The main question this study aims to answer is: • Does Ondansetron plus Metoclopramide prolong time to first rescue antiemetic more than Dexamethasone plus Metoclopramide? Researchers will compare Group A (Ondansetron 4mg plus Metoclopramide 10mg IV) to Group B (Dexamethasone 8mg IV plus Metoclopramide 10mg IV) to see if Group A provides a longer time to first rescue medication. Participants will: * Receive their assigned, blinded drug group 5-10 minutes before general anesthesia induction. * Receive rescue Metoclopramide 10mg IV if they experience any vomiting or severe nausea * Be monitored for 24 hours post-surgery in the hospital * Report nausea severity at 2, 6, 12 and 24 hours post-surgery

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• American Society of Anesthesiologists (ASA) physical status I or II

• Scheduled for elective laparoscopic cholecystectomy

• Apfel score 2-4 (moderate to high risk for PONV)

• Provides written informed consent prior to enrollment

Locations
Other Locations
Pakistan
Faisalabad Medical University
RECRUITING
Faisalābad
Contact Information
Primary
Asifa Saeed, MBBS; FCPS
drasifasaeed@gmail.com
+923006694460
Backup
Huda Ather, MBBS
atherhudaather@gmail.com
+923047922909
Time Frame
Start Date: 2026-09
Estimated Completion Date: 2027-04
Participants
Target number of participants: 264
Treatments
Experimental: Group A (Ondansetron and Metoclopramide)- Separate syringes
Participants receive~* Ondansetron (4 mg IV) and~* Metoclopramide (10 mg IV), in two separate colorless syringes, 5-10 minutes before the induction of general anesthesia.
Active_comparator: Group B (Dexamethasone and Metoclopramide)- Separate syringes
Participants receive~* Dexamethasone 8mg IV and~* Metoclopramide 10mg IV, in two separate colorless syringes, 5-10 minutes before the induction of general anesthesia.
Related Therapeutic Areas
Sponsors
Leads: Faisalabad Medical University

This content was sourced from clinicaltrials.gov

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