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Trial record 4 of 121 for:    Recruiting, Not yet recruiting, Available Studies | Nausea and vomiting

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

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ClinicalTrials.gov Identifier: NCT03459248
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Zoher Naja, Makassed General Hospital

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 Surgery
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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.




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 surgeries. 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



Information from the National Library of Medicine

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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
  • All laparoscopic surgeries done under General Anesthesia at Makassed General Hospital including:

    1. Lap Cholecystectomy
    2. Lap gastric sleeve
    3. Lap gastric plication
    4. Lap gastric mini-bypass
    5. Lap ovarian cystectomy

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

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


Contacts
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Contact: Zoher Naja +9611636000 ext 6405 zouhnaja@yahoo.com

Locations
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Lebanon
Makassed General Hospital Recruiting
Beirut, Lebanon
Contact: Zoher Naja, MD    +9611636000 ext 6405    zouhnaja@yahoo.com   
Sponsors and Collaborators
Makassed General Hospital

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Responsible Party: Zoher Naja, Chairperson of Anesthesia and Pain Management Department, Makassed General Hospital
ClinicalTrials.gov Identifier: NCT03459248     History of Changes
Other Study ID Numbers: 122018
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 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
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Anesthetics
Ondansetron
Metoclopramide
Central Nervous System Depressants
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Anti-Anxiety Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents