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

Phase 4

Completed

• Conditions: Laparoscopy; Postoperative Nausea and Vomiting
• Interventions: Drug: Haloperidol Injection; Drug: Dexamethasone injection

• Registration Number: NCT05246631
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-03-30
• Study Completion: 2020-07-30
• Study First Submitted: 2022-01-25
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-15
• Last Update Submitted: 2022-02-15
• Study First Posted: 2022-02-18
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Haloperidol	Haloperidol Injection	1 mg intravenous haloperidol
Dexamethasone	Dexamethasone injection	5 mg intravenous dexamethasone

Primary Outcome Measures

Name	Time	Method
Nausea and Vomiting	Within 24 hours postoperative	Number of patients experiencing nausea and vomiting postoperative

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cipto Mangunkusumo Central National Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia