CClinicalTrials.gg
CompletedNCT03459248Updated Sep 27, 2019

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

An interventional study of Dual therapy and Monotherapy in Postoperative Nausea and Vomiting, sponsored by Makassed General Hospital. Completed at 1 site in Lebanon. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2019-09-27.

Sponsored by Makassed General Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Postoperative Nausea and Vomiting
03

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Dual therapy

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

    Other: Dual therapy · Other: General anesthesia

  • Active comparator
    Monotherapy

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

    Other: Monotherapy · Other: General anesthesia

Interventions

  • OtherDual therapy

    combination of 10 mg metoclopramide with 4 mg ondansetron

  • OtherMonotherapy

    10 mg metoclopramide

  • OtherGeneral anesthesia

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

05

What researchers measure

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.

    Time frame: 36 hours postoperatively

Secondary outcomes

  1. 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

    Time frame: 36 hours postoperatively

  2. 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

    Time frame: 36 hours postoperatively

06

Study locations

1 site
  • Makassed General Hospital
    Beirut, Lebanon
07

Registry details

Key details

Study ID
NCT03459248
Lead sponsor
Makassed General Hospital
Responsible party
Zoher Naja (Chairperson of Anesthesia and Pain Management Department, Makassed General Hospital) — Principal investigator
First posted
Mar 8, 2018
Start date
Feb 15, 2018
Primary completion
Jul 31, 2019
Completion
Jul 31, 2019
Last update
Sep 27, 2019

Study contacts

Zoher Naja, MD
principal investigator · Makassed General Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion