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

University of Indonesia (UI)

Status and phase: Completed; Phase 4

Conditions: Laparoscopy; Postoperative Nausea and Vomiting

Treatments: Drug: Haloperidol Injection; Drug: Dexamethasone injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05246631

IndonesiaUAnes393

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Dexamethasone

Active Comparator group

Description:

5 mg intravenous dexamethasone

Treatment:

Drug: Dexamethasone injection

Haloperidol

Active Comparator group

Description:

1 mg intravenous haloperidol

Treatment:

Drug: Haloperidol Injection