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

NCT ID: NCT05246631

Last Updated: 2022-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Laparoscopy Postoperative Nausea and Vomiting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dexamethasone

5 mg intravenous dexamethasone

Group Type ACTIVE_COMPARATOR

Dexamethasone injection

Intervention Type DRUG

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

Haloperidol

1 mg intravenous haloperidol

Group Type ACTIVE_COMPARATOR

Haloperidol Injection

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexamethasone injection

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

Intervention Type DRUG

Haloperidol Injection

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

dexamethasone haloperidol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Indonesia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aldy Heriwardito

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aldy Heriwardito, Doctor

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IndonesiaUAnes393

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.