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

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT05246631
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
6.9
Actual Duration (Months)
11.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone injection
  • Drug: Haloperidol Injection
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Haloperidol Compared to Dexamethasone in Lowering Postoperative Nausea and Vomiting and Pain in Adult After Laparoscopy
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Mar 30, 2020
Actual Study Completion Date :
Jul 30, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Nausea and Vomiting [Within 24 hours postoperative]

      Number of patients experiencing nausea and vomiting postoperative

    Secondary Outcome Measures

    1. Pain and VAS [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cipto Mangunkusumo Central National Hospital Jakarta Pusat DKI Jakarta Indonesia 10430

    Sponsors and Collaborators

    • Indonesia University

    Investigators

    • Principal Investigator: Aldy Heriwardito, Doctor, Indonesia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aldy Heriwardito, Principal Investigator, Indonesia University
    ClinicalTrials.gov Identifier:
    NCT05246631
    Other Study ID Numbers:
    • IndonesiaUAnes393
    First Posted:
    Feb 18, 2022
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Keywords provided by Aldy Heriwardito, Principal Investigator, Indonesia University
    dexamethasone
    haloperidol
    nausea
    pain
    vomiting
    Additional relevant MeSH terms:
    Nausea
    Vomiting
    Postoperative Nausea and Vomiting
    Dexamethasone
    Dexamethasone acetate
    Haloperidol
    Haloperidol decanoate
    BB 1101

    Study Results

    No Results Posted as of Feb 18, 2022