Back to resultsMetoclopramide-Ondansetron vs. Metoclopramide Therapy for Treatment of Nausea and Vomiting Post Laparoscopic Surgery
Primary Purpose
Postoperative Nausea and Vomiting
Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Dual therapy
Monotherapy
General anesthesia
Sponsored by
About this trial
This is an interventional other trial for Postoperative Nausea and Vomiting
Eligibility 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
Sites / Locations
- Makassed General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dual therapy
Monotherapy
Arm Description
Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia
Patients will receive 10 mg metoclopramide before induction of general anesthesia.
Outcomes
Primary Outcome Measures
postoperative nausea and vomiting
The Primary aim of this study is to compare the effect of prophylactic combination therapy (dual therapy) metoclopramide-ondansetron vs. ondansetron monotherapy for the treatment of postoperative nausea and vomiting after laparoscopic cholecystectomy. This will be assessed through a questionnaire with yes or no question where yes indicates the presence of nausea or vomiting and no indicating the absence of nausea or vomiting.
Secondary Outcome Measures
Surgeon satisfaction
Assess surgeon satisfaction with anesthesia using a questionnaire named "the Surgeon Satisfaction with Anesthesia Services Scales". The questionnaire uses a scale: 1-strongly disagree, 2- disagree, 3- agree, 4- strongly agree
Patient satisfaction
Assess patient satisfaction with anesthesia using the Iowa Satisfaction Anesthesia scale which measures patient satisfaction through a scale: strongly disagree, disagree, undecided, agree and strongly agree
Full Information
NCT ID
NCT03459248
First Posted
March 3, 2018
Last Updated
September 26, 2019
Sponsor
Makassed General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03459248
Brief Title
Metoclopramide-Ondansetron vs. Metoclopramide Therapy for Treatment of Nausea and Vomiting Post Laparoscopic Surgery
Official Title
Metoclopramide-Ondansetron Dual Therapy vs Metoclopramide Monotherapy for Treatment of Nausea and Vomiting Post Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dual therapy
Arm Type
Experimental
Arm Description
Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia
Arm Title
Monotherapy
Arm Type
Active Comparator
Arm Description
Patients will receive 10 mg metoclopramide before induction of general anesthesia.
Intervention Type
Other
Intervention Name(s)
Dual therapy
Intervention Description
combination of 10 mg metoclopramide with 4 mg ondansetron
Intervention Type
Other
Intervention Name(s)
Monotherapy
Intervention Description
10 mg metoclopramide
Intervention Type
Other
Intervention Name(s)
General anesthesia
Intervention Description
Induction of general anesthesia will be performed followed by endotracheal intubation.
Primary Outcome Measure Information:
Title
postoperative nausea and vomiting
Description
The Primary aim of this study is to compare the effect of prophylactic combination therapy (dual therapy) metoclopramide-ondansetron vs. ondansetron monotherapy for the treatment of postoperative nausea and vomiting after laparoscopic cholecystectomy. This will be assessed through a questionnaire with yes or no question where yes indicates the presence of nausea or vomiting and no indicating the absence of nausea or vomiting.
Time Frame
36 hours postoperatively
Secondary Outcome Measure Information:
Title
Surgeon satisfaction
Description
Assess surgeon satisfaction with anesthesia using a questionnaire named "the Surgeon Satisfaction with Anesthesia Services Scales". The questionnaire uses a scale: 1-strongly disagree, 2- disagree, 3- agree, 4- strongly agree
Time Frame
36 hours postoperatively
Title
Patient satisfaction
Description
Assess patient satisfaction with anesthesia using the Iowa Satisfaction Anesthesia scale which measures patient satisfaction through a scale: strongly disagree, disagree, undecided, agree and strongly agree
Time Frame
36 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoher Naja, MD
Organizational Affiliation
Makassed General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
Learn more about this trial
Metoclopramide-Ondansetron vs. Metoclopramide Therapy for Treatment of Nausea and Vomiting Post Laparoscopic Surgery
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