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Metoclopramide-Ondansetron vs. Metoclopramide Therapy for Treatment of Nausea and Vomiting Post Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT03459248
Recruitment Status : Completed
First Posted : March 8, 2018
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Zoher Naja, Makassed General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Other: Dual therapy Other: Monotherapy Other: General anesthesia Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Metoclopramide-Ondansetron Dual Therapy vs Metoclopramide Monotherapy for Treatment of Nausea and Vomiting Post Laparoscopic Cholecystectomy
Actual Study Start Date : February 15, 2018
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dual therapy
Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia
 Other: Dual therapy
combination of 10 mg metoclopramide with 4 mg ondansetron

Other: General anesthesia
Induction of general anesthesia will be performed followed by endotracheal intubation.
Active Comparator: Monotherapy
Patients will receive 10 mg metoclopramide before induction of general anesthesia.
 Other: Monotherapy
10 mg metoclopramide

Other: General anesthesia
Induction of general anesthesia will be performed followed by endotracheal intubation.


Outcome Measures
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Primary Outcome Measures :
  1. postoperative nausea and vomiting [ Time Frame: 36 hours postoperatively ]
    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 :
  1. Surgeon satisfaction [ Time Frame: 36 hours postoperatively ]
    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

  2. Patient satisfaction [ Time Frame: 36 hours postoperatively ]
    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


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459248


Locations
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Lebanon
Makassed General Hospital
Beirut, Lebanon
Sponsors and Collaborators
Makassed General Hospital
Investigators
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Principal Investigator: Zoher Naja, MD Makassed General Hospital
More Information
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Responsible Party: Zoher Naja, Chairperson of Anesthesia and Pain Management Department, Makassed General Hospital
ClinicalTrials.gov Identifier: NCT03459248    
Other Study ID Numbers: 122018
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Postoperative Complications
 Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs