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Completed

NCT Number: NCT05246631

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

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.

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Key information

Conditions

Laparoscopy Nausea Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone Injection

Drug

Group A consisted of patients given 5 mg intravenous dexamethasone after induction.

Other names: dexamethasone

Haloperidol Injection

Drug

Group B consisted of patients given 1 mg intravenous haloperidol one hour before the surgery ended

Other names: haloperidol

Primary outcomes

  1. Nausea and Vomiting

    Time frame: Within 24 hours postoperative

    Number of patients experiencing nausea and vomiting postoperative

Secondary outcomes

  1. Pain and VAS

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 18, 2022
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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