Opioid Free Versus Opioid Balanced Anesthesia in Ophthalm... | NCT06382831

Studies
Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery

NCT06382831

Sponsor

Indonesia University

Status

Unknown status

Last Update Posted

Apr 30, 2024Actual

Enrollment

104Estimated

Phase

Phase 2Phase 3

Conditions

Anesthesia and Analgesia
Anesthesia, Endotracheal

Interventions

Dexmedetomidine
Fentanyl

Countries

Not provided

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

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Estimated

Primary Completion Date

Aug 1, 2024Estimated

Completion Date

Oct 1, 2024Estimated

First Submitted Date

Apr 19, 2024

First Submission Date that Met QC Criteria

Apr 19, 2024

First Posted Date

Apr 24, 2024Actual

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

Apr 27, 2024

Last Update Posted Date

Apr 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Anesthesia without the use of opioid (Opioid free anesthesia) is an alternative to conventional opioid balanced anesthesia, with less post operative nausea and vomiting, and comparable analgesia. This study aim to compare the effect of opioid free versus opioid balanced anesthesia in ophthalmology surgery

Detailed Description

Not provided

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator		Drug: Fentanyl
Opioid free anesthesia	Experimental		Drug: Dexmedetomidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	Opioid free anesthesia	Opioid free anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative nausea and vomiting (PONV)	Incidence of PONV	24 hours
Pain score	Pain score assessed with numerical rating scale (0-10) where higher value corresponds to more pain experienced by the patient	24 hours
Time to laryngeal mask exertion	Measured from the last surgical knot to LMA exertion	Intraoperative
Adverse effect	Severe changes in hemodynamics, including severe bradycardia, tachycardia, hypotension, hypertension, desaturation	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Physical status of ASA 1-2
Undergo elective ophthalmology surgery under general anesthesia with laryngeal mask insertion
BMI 17.5-34.9

Exclusion Criteria:

Allergy to study drugs
Baseline heart rate < 70 beat per minute or systolic blood pressure < 100 mmHg
Will undergo regional block
Operation lasting for > 4 hours or < 90 minutes
Consumes opioid routinely prior to operation

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Participants' data is kept under strict regulation by the study investigator and will not be shared without participants' consent

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia
D014839	Vomiting

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
D005283	Fentanyl

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided