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Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
4 mg of Ondansetron IV
1mg of Haloperidol IV
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 18-80
  • ASA class I, II, and III
  • undergoing elective surgery under general anesthesia

Exclusion Criteria:

  • Patients with history of arrhythmias, QTc prolongation or allergies to the study drugs will be excluded from the study.

Sites / Locations

  • Marie Aouad

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group I

Group II

Arm Description

Patients will receive 4 mg of Ondansetron IV upon occurrence of nausea or vomiting

Patients will receive 1mg of Haloperidol IV upon occurrence of nausea or vomiting

Outcomes

Primary Outcome Measures

The success of the anti-emetic administered in treating the postoperative nausea and vomiting (PONV)
Investigators will assess the success rate of the anti-emetic used: resolution of post-operative nausea and vomiting within 30 minutes from the adminstration of the anti-emetic will be considered "success".

Secondary Outcome Measures

Severity of postoperative nausea and vomiting (PONV)
Investigators will ask patients to grade the severity of their nausea episodes using the following scale: 0. No nausea; 1. mild ; 2. Discomforting; 3. Distressing; 4. Horrible; 5. Worst possible
Recurrence of postoperative nausea and vomiting (PONV)
Side effects in PACU
Headache, Dizzines / Vertigo, Restlessness, Nystagmus or other extra-pyramidal symptoms, Sedation highest score, Pain highest score, QT prolongation
Patient satisfaction
24 hours following surgery, investigators will ask patients to grade their satisfaction with the treatment of post-operative nausea and vomiting using the following scale: 1. Excellent; 2. Good; 3. Fair; 4. Bad
Rescue anti-emetic

Full Information

First Posted
May 15, 2014
Last Updated
May 21, 2014
Sponsor
American University of Beirut Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02143531
Brief Title
Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting
Official Title
Intravenous Haloperidol Versus Ondansetron for Treatment of Established Nausea and Vomiting in Patients Undergoing Surgery With General Anesthesia: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to prove that at a dose of 1 mg Haloperidol possesses a high success rate in controlling established postoperative nausea and vomiting (PONV) in the first 24 hours following administration similar to the standard of care ondansetron 4 mg.
Detailed Description
Patients undergoing surgery under general anesthesia may experience several complications in their postoperative period. Nausea and vomiting are some of the more common of these complications. Several medications can be used for prevention of these specific complications, but treatment remains more cost-efficient. Haloperidol is anti-psychotic which, at low doses, can prevent the occurrence of nausea and vomiting. Its usefulness for prophylaxis has been demonstrated in several studies. However, its use for treating established postoperative nausea and vomiting (PONV) has not been properly studied. In a prospective randomized clinical trial involving adult patients undergoing elective surgery under general anesthesia, investigators will enroll 120 patients, and compare the effect of a dose of 1 mg Haloperidol versus Ondansetron 4 mg and document the varying degrees of success in treating nausea and vomiting as well as possible side effects. Investigators expect to observe that Haloperidol is as effective as treatment with Ondansetron.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
Patients will receive 4 mg of Ondansetron IV upon occurrence of nausea or vomiting
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Patients will receive 1mg of Haloperidol IV upon occurrence of nausea or vomiting
Intervention Type
Drug
Intervention Name(s)
4 mg of Ondansetron IV
Intervention Type
Drug
Intervention Name(s)
1mg of Haloperidol IV
Primary Outcome Measure Information:
Title
The success of the anti-emetic administered in treating the postoperative nausea and vomiting (PONV)
Description
Investigators will assess the success rate of the anti-emetic used: resolution of post-operative nausea and vomiting within 30 minutes from the adminstration of the anti-emetic will be considered "success".
Time Frame
during the first hour postoperatively
Secondary Outcome Measure Information:
Title
Severity of postoperative nausea and vomiting (PONV)
Description
Investigators will ask patients to grade the severity of their nausea episodes using the following scale: 0. No nausea; 1. mild ; 2. Discomforting; 3. Distressing; 4. Horrible; 5. Worst possible
Time Frame
during the first 24 hours postoperatively
Title
Recurrence of postoperative nausea and vomiting (PONV)
Time Frame
during first 24 hours postoperatively
Title
Side effects in PACU
Description
Headache, Dizzines / Vertigo, Restlessness, Nystagmus or other extra-pyramidal symptoms, Sedation highest score, Pain highest score, QT prolongation
Time Frame
1 hour postoperatively
Title
Patient satisfaction
Description
24 hours following surgery, investigators will ask patients to grade their satisfaction with the treatment of post-operative nausea and vomiting using the following scale: 1. Excellent; 2. Good; 3. Fair; 4. Bad
Time Frame
24 hours after surgery
Title
Rescue anti-emetic
Time Frame
during the first 24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18-80 ASA class I, II, and III undergoing elective surgery under general anesthesia Exclusion Criteria: Patients with history of arrhythmias, QTc prolongation or allergies to the study drugs will be excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Aouad, MD
Organizational Affiliation
American Univesity of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marie Aouad
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

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Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting

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