Back to resultsHaloperidol and Dexamethasone Towards Postoperative Nausea and Pain in Adult After Laparoscopy
Primary Purpose
Laparoscopy, Postoperative Nausea and Vomiting
Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
Dexamethasone injection
Haloperidol Injection
Sponsored by
About this trial
This is an interventional treatment trial for Laparoscopy focused on measuring dexamethasone, haloperidol, nausea, pain, vomiting
Eligibility Criteria
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
Sites / Locations
- Cipto Mangunkusumo Central National Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dexamethasone
Haloperidol
Arm Description
5 mg intravenous dexamethasone
1 mg intravenous haloperidol
Outcomes
Primary Outcome Measures
Nausea and Vomiting
Number of patients experiencing nausea and vomiting postoperative
Secondary Outcome Measures
Pain and VAS
Visual Analog Scale (VAS) score, the minimum score is 0 and the maximum score is 10. The higher scores mean a worse outcome
Full Information
NCT ID
NCT05246631
First Posted
January 25, 2022
Last Updated
February 15, 2022
Sponsor
Indonesia University
1. Study Identification
Unique Protocol Identification Number
NCT05246631
Brief Title
Haloperidol and Dexamethasone Towards Postoperative Nausea and Pain in Adult After Laparoscopy
Official Title
Haloperidol Compared to Dexamethasone in Lowering Postoperative Nausea and Vomiting and Pain in Adult After Laparoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopy, Postoperative Nausea and Vomiting
Keywords
dexamethasone, haloperidol, nausea, pain, vomiting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
5 mg intravenous dexamethasone
Arm Title
Haloperidol
Arm Type
Active Comparator
Arm Description
1 mg intravenous haloperidol
Intervention Type
Drug
Intervention Name(s)
Dexamethasone injection
Other Intervention Name(s)
dexamethasone
Intervention Description
Group A consisted of patients given 5 mg intravenous dexamethasone after induction.
Intervention Type
Drug
Intervention Name(s)
Haloperidol Injection
Other Intervention Name(s)
haloperidol
Intervention Description
Group B consisted of patients given 1 mg intravenous haloperidol one hour before the surgery ended
Primary Outcome Measure Information:
Title
Nausea and Vomiting
Description
Number of patients experiencing nausea and vomiting postoperative
Time Frame
Within 24 hours postoperative
Secondary Outcome Measure Information:
Title
Pain and VAS
Description
Visual Analog Scale (VAS) score, the minimum score is 0 and the maximum score is 10. The higher scores mean a worse outcome
Time Frame
0-2 hours, 2-6 hours, 6-12 hours, and 12-24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldy Heriwardito, Doctor
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo Central National Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Haloperidol and Dexamethasone Towards Postoperative Nausea and Pain in Adult After Laparoscopy
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