Haloperidol and Dexamethasone Towards Postoperative Nause... | NCT05246631

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

NCT05246631

Sponsor

Indonesia University

Status

Completed

Last Update Posted

Feb 18, 2022Actual

Enrollment

80Actual

Phase

Phase 4

Conditions

Laparoscopy
Postoperative Nausea and Vomiting

Interventions

Dexamethasone injection
Haloperidol Injection

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Mar 30, 2020Actual

Completion Date

Jul 30, 2020Actual

First Submitted Date

Jan 25, 2022

First Submission Date that Met QC Criteria

Feb 15, 2022

First Posted Date

Feb 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2022

Last Update Posted Date

Feb 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexamethasone	Active Comparator	5 mg intravenous dexamethasone	Drug: Dexamethasone injection
Haloperidol	Active Comparator	1 mg intravenous haloperidol	Drug: Haloperidol Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone injection	Drug	Group A consisted of patients given 5 mg intravenous dexamethasone after induction.	Dexamethasone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nausea and Vomiting	Number of patients experiencing nausea and vomiting postoperative	Within 24 hours postoperative

Secondary Outcomes

Measure	Description	Time Frame
Pain and VAS	Visual Analog Scale (VAS) score, the minimum score is 0 and the maximum score is 10. The higher scores mean a worse outcome	0-2 hours, 2-6 hours, 6-12 hours, and 12-24 hours postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aldy Heriwardito, Doctor	Indonesia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cipto Mangunkusumo Central National Hospital		Jakarta Pusat	DKI Jakarta	10430	Indonesia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting
D009325	Nausea
D010146	Pain
D014839	Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012817	Signs and Symptoms, Digestive

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002123	Calcium Dobesilate
D003907	Dexamethasone
D006220	Haloperidol

Ancestor Terms

ID	Term
D001557	Benzenesulfonates
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided