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Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery

Comparing Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery: a Single Centre Randomized Controlled Trial

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06382831
Enrollment
104
Registered
2024-04-24
Start date
2024-06-01
Completion date
2024-10-01
Last updated
2024-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia and Analgesia, Anesthesia, Endotracheal

Keywords

Opioid free anesthesia, Ocular surgery, Ophthalmology surgery, Dexmedetomidine, Post operative nausea and vomiting

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

Interventions

DRUGDexmedetomidine

Opioid free anesthesia

DRUGFentanyl

Control given Opioid balanced anesthesia

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative nausea and vomiting (PONV)24 hoursIncidence of PONV
Pain score24 hoursPain score assessed with numerical rating scale (0-10) where higher value corresponds to more pain experienced by the patient
Time to laryngeal mask exertionIntraoperativeMeasured from the last surgical knot to LMA exertion
Adverse effect24 hoursSevere changes in hemodynamics, including severe bradycardia, tachycardia, hypotension, hypertension, desaturation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026