Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery

Phase 3Not Yet RecruitingNCT06382831

Indonesia University104 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Anesthesia and Analgesia Anesthesia, Endotracheal

Interventions

DexmedetomidineDRUG

Opioid free anesthesia

FentanylDRUG

Control given Opioid balanced anesthesia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Postoperative nausea and vomiting (PONV)

Incidence of PONV

Time frame: 24 hours

Pain score

Pain score assessed with numerical rating scale (0-10) where higher value corresponds to more pain experienced by the patient

Time frame: 24 hours

Time to laryngeal mask exertion

Measured from the last surgical knot to LMA exertion

Time frame: Intraoperative

Adverse effect

Severe changes in hemodynamics, including severe bradycardia, tachycardia, hypotension, hypertension, desaturation

Time frame: 24 hours

Data from ClinicalTrials.gov

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