NCT03459248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

1.5 years

First QC Date

March 3, 2018

Last Update Submit

September 26, 2019

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • 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.

    36 hours postoperatively

Secondary Outcomes (2)

  • Surgeon satisfaction

    36 hours postoperatively

  • Patient satisfaction

    36 hours postoperatively

Study Arms (2)

Dual therapy

EXPERIMENTAL

Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia

Other: Dual therapyOther: General anesthesia

Monotherapy

ACTIVE COMPARATOR

Patients will receive 10 mg metoclopramide before induction of general anesthesia.

Other: MonotherapyOther: General anesthesia

Interventions

Dual therapyOTHER

combination of 10 mg metoclopramide with 4 mg ondansetron

Dual therapy
MonotherapyOTHER

10 mg metoclopramide

Monotherapy
General anesthesiaOTHER

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

Dual therapyMonotherapy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aging 16 years and above
  • Patients undergoing laparoscopic cholecystectomy under General Anesthesia at Makassed General Hospital

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dual Anti-Platelet TherapyAnesthesia, General

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

Drug Therapy, CombinationDrug TherapyTherapeuticsAnesthesiaAnesthesia and Analgesia

Study Officials

  • Zoher Naja, MD

    Makassed General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairperson of Anesthesia and Pain Management Department

Study Record Dates

First Submitted

March 3, 2018

First Posted

March 8, 2018

Study Start

February 15, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

September 27, 2019

Record last verified: 2019-09

Locations

LE(1)