Haloperidol and Dexamethasone Towards Postoperative Nausea and Pain in Adult After Laparoscopy

February 15, 2022 updated by: Aldy Heriwardito, Indonesia University

Haloperidol Compared to Dexamethasone in Lowering Postoperative Nausea and Vomiting and Pain in Adult After Laparoscopy

This study aim to find out the effectiveness of 1 mg intravenous haloperidol compared to 5 mg intravenous dexamethasone to prevent the occurrence of nausea and vomiting also as pain control in adult patients after laparoscopic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eighty subjects (n=40 for each group) scheduled for laparoscopic-assisted surgery were enrolled in a randomized double-blind clinical trial. One milligram intravenous haloperidol was given one hour before the end of surgery, while 5 mg intravenous dexamethasone was given right after induction. The occurrence of Postoperative Nausea and Vomiting (PONV) and visual analog scale (VAS) pain score were recorded.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo Central National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • underwent laparoscopic surgery (gynecology, digestive, or urology surgery)
  • American Society of Anesthesiologist (ASA) physical status 1-3

Exclusion Criteria:

  • psychological or neurological disorders (routine haloperidol consumption)
  • history of allergic reaction to dexamethasone or haloperidol
  • diabetes mellitus
  • did not give the consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone
5 mg intravenous dexamethasone
Drug: Dexamethasone injection
Group A consisted of patients given 5 mg intravenous dexamethasone after induction.
Other Names:
  • dexamethasone
Active Comparator: Haloperidol
1 mg intravenous haloperidol
Drug: Haloperidol Injection
Group B consisted of patients given 1 mg intravenous haloperidol one hour before the surgery ended
Other Names:
  • haloperidol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea and Vomiting
Time Frame: Within 24 hours postoperative
Number of patients experiencing nausea and vomiting postoperative
Within 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain and VAS
Time Frame: 0-2 hours, 2-6 hours, 6-12 hours, and 12-24 hours postoperative
Visual Analog Scale (VAS) score, the minimum score is 0 and the maximum score is 10. The higher scores mean a worse outcome
0-2 hours, 2-6 hours, 6-12 hours, and 12-24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Aldy Heriwardito, Doctor, Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

July 30, 2020

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndonesiaUAnes393

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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