Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery

NCT ID: NCT06382831

Last Updated: 2024-04-30

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

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-10-01

Brief Summary

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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

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Conditions

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Anesthesia and Analgesia Anesthesia, Endotracheal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Control given Opioid balanced anesthesia

Opioid free anesthesia

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Opioid free anesthesia

Interventions

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Dexmedetomidine

Opioid free anesthesia

Intervention Type DRUG

Fentanyl

Control given Opioid balanced anesthesia

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Aida Rosita Tantri

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IndonesiaU240201

Identifier Type: -

Identifier Source: org_study_id

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