Metoclopramide-Ondansetron Dual Therapy vs Metoclopramide Monotherapy for Treatment of Nausea and Vomiting Post Laparoscopic Cholecystectomy
| Registry | NCT03459248 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, other |
| Enrollment | 120 (Actual) |
| Sponsor | Makassed General Hospital (Other) |
| Conditions | Postoperative Nausea and Vomiting |
| Interventions | Dual therapy, Monotherapy, General anesthesia (Other) |
| Dates | start 2018-02-15, primary completion 2019-07-31, completion 2019-07-31, first posted 2018-03-08, last updated 2019-09-27 |
| Locations | 1 site in Lebanon |
Related Papers Related Patents Related Grants Related Experts
All trials for Postoperative Nausea and Vomiting All trials of Dual therapy All trials of Monotherapy
The incidence of postoperative nausea and vomiting (PONV) after general anesthesia is up to 30% when inhalational anesthetics are used with no prophylaxis. This makes PONV one of the most common complaints following surgery under general anesthesia, together with postoperative pain.
This is a prospective, randomized, double-blind controlled clinical trial. Written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 equal groups:
Group 1: Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia.
Group 2: Patients will receive 10 mg metoclopramide before induction of general anesthesia.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Dual therapy | Experimental | Other: Dual therapy; Other: General anesthesia | Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia |
| Monotherapy | Active comparator | Other: Monotherapy; Other: General anesthesia | Patients will receive 10 mg metoclopramide before induction of general anesthesia. |
Sex: All, ages: 16 Years to any
Inclusion Criteria: * Patients aging 16 years and above * Patients undergoing laparoscopic cholecystectomy under General Anesthesia at Makassed General Hospital Exclusion Criteria: * Patients with history of motion sickness * Patients on previous treatment by anti-emetics for dizziness, vertigo or other causes of nausea and vomiting * Patients with any type of allergy to metoclopramide or ondansetron * Patients refusing to be part of the study (refusal to sign consent) * Patients on previous treatment by opioids
| Facility | City | Country | Status |
|---|---|---|---|
| Makassed General Hospital | Beirut | Lebanon |