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NCT05246631 Clinical Trial

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

Postoperative Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05246631
Other study ID # IndonesiaUAnes393
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2020
Est. completion date July 30, 2020

Study information
Verified date February 2022
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date July 30, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexamethasone injection
Group A consisted of patients given 5 mg intravenous dexamethasone after induction.
• Haloperidol Injection
Group B consisted of patients given 1 mg intravenous haloperidol one hour before the surgery ended

Locations
Country Name City State
Indonesia Cipto Mangunkusumo Central National Hospital Jakarta Pusat DKI Jakarta

Sponsors (1)
Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Nausea and Vomiting Number of patients experiencing nausea and vomiting postoperative Within 24 hours postoperative
Secondary 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 0-2 hours, 2-6 hours, 6-12 hours, and 12-24 hours postoperative
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