NCT05246631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

January 25, 2022

Last Update Submit

February 15, 2022

Conditions

LaparoscopyPostoperative Nausea and Vomiting

Keywords

dexamethasonehaloperidolnauseapainvomiting

Outcome Measures

Primary Outcomes (1)

  • Nausea and Vomiting

    Number of patients experiencing nausea and vomiting postoperative

    Within 24 hours postoperative

Secondary Outcomes (1)

  • Pain and VAS

    0-2 hours, 2-6 hours, 6-12 hours, and 12-24 hours postoperative

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

5 mg intravenous dexamethasone

Drug: Dexamethasone injection

Haloperidol

ACTIVE COMPARATOR

1 mg intravenous haloperidol

Drug: Haloperidol Injection

Interventions

Dexamethasone injectionDRUG

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

Also known as: dexamethasone
Dexamethasone
Haloperidol InjectionDRUG

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

Also known as: haloperidol
Haloperidol

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • underwent laparoscopic surgery (gynecology, digestive, or urology surgery)
  • American Society of Anesthesiologist (ASA) physical status 1-3

You may not qualify if:

  • psychological or neurological disorders (routine haloperidol consumption)
  • history of allergic reaction to dexamethasone or haloperidol
  • diabetes mellitus
  • did not give the consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Postoperative Nausea and VomitingNauseaPainVomiting

Interventions

Calcium DobesilateDexamethasoneHaloperidol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and SymptomsNeurologic Manifestations

Intervention Hierarchy (Ancestors)

BenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedButyrophenonesKetones

Study Officials

  • Aldy Heriwardito, Doctor

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2022

First Posted

February 18, 2022

Study Start

January 1, 2020

Primary Completion

March 30, 2020

Study Completion

July 30, 2020

Last Updated

February 18, 2022

Record last verified: 2022-02

Locations

ID(1)