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

NCT03459248 — Not applicable, Completed, 120 participants, Makassed General Hospital

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Metoclopramide-Ondansetron Dual Therapy vs Metoclopramide Monotherapy for Treatment of Nausea and Vomiting Post Laparoscopic Cholecystectomy

RegistryNCT03459248
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, other
Enrollment120 (Actual)
SponsorMakassed General Hospital (Other)
ConditionsPostoperative Nausea and Vomiting
InterventionsDual therapy, Monotherapy, General anesthesia (Other)
Datesstart 2018-02-15, primary completion 2019-07-31, completion 2019-07-31, first posted 2018-03-08, last updated 2019-09-27
Locations1 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

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Dual therapyExperimentalOther: Dual therapy; Other: General anesthesiaPatients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia
MonotherapyActive comparatorOther: Monotherapy; Other: General anesthesiaPatients will receive 10 mg metoclopramide before induction of general anesthesia.
  • Dual therapy (Other): combination of 10 mg metoclopramide with 4 mg ondansetron
  • Monotherapy (Other): 10 mg metoclopramide
  • General anesthesia (Other): Induction of general anesthesia will be performed followed by endotracheal intubation.

+Outcome measures

Primary outcomes

  • postoperative nausea and vomiting [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 outcomes

  • Surgeon satisfaction [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
  • Patient satisfaction [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

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

+Locations (1)

FacilityCityCountryStatus
Makassed General HospitalBeirutLebanon

+Investigators