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Clinical Trials/NCT06382831
NCT06382831
Not yet recruiting
Phase 2

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

Indonesia University0 sites104 target enrollmentJune 1, 2024

Overview

Phase
Phase 2
Intervention
Fentanyl
Conditions
Anesthesia and Analgesia
Sponsor
Indonesia University
Enrollment
104
Primary Endpoint
Postoperative nausea and vomiting (PONV)
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
October 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aida Rosita Tantri

Anesthesiologist

Indonesia University

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

Arms & Interventions

Control

Intervention: Fentanyl

Opioid free anesthesia

Intervention: Dexmedetomidine

Outcomes

Primary Outcomes

Postoperative nausea and vomiting (PONV)

Time Frame: 24 hours

Incidence of PONV

Time to laryngeal mask exertion

Time Frame: Intraoperative

Measured from the last surgical knot to LMA exertion

Adverse effect

Time Frame: 24 hours

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

Pain score

Time Frame: 24 hours

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

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