|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03459248 |
|
Date of registration:
|
03/03/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Metoclopramide-Ondansetron vs. Metoclopramide Therapy for Treatment of Nausea and Vomiting Post Laparoscopic Surgery
|
|
Scientific title:
|
Metoclopramide-Ondansetron Dual Therapy vs Metoclopramide Monotherapy for Treatment of Nausea and Vomiting Post Laparoscopic Cholecystectomy |
|
Date of first enrolment:
|
February 15, 2018 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03459248 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Triple (Participant, Care Provider, Investigator).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Lebanon
| | | | | | | |
|
Contacts
|
|
Name:
|
Zoher Naja, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Makassed General Hospital |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
16 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Postoperative Nausea and Vomiting
|
|
Intervention(s)
|
|
Other: Dual therapy
|
|
Other: General anesthesia
|
|
Other: Monotherapy
|
|
Primary Outcome(s)
|
|
postoperative nausea and vomiting
[Time Frame: 36 hours postoperatively]
|
|
Secondary Outcome(s)
|
|
Surgeon satisfaction
[Time Frame: 36 hours postoperatively]
|
|
Patient satisfaction
[Time Frame: 36 hours postoperatively]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|