Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery

April 27, 2024 updated by: Aida Rosita Tantri, Indonesia University

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Drug: Fentanyl
Control given Opioid balanced anesthesia
Experimental: Opioid free anesthesia
Drug: Dexmedetomidine
Opioid free anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative nausea and vomiting (PONV)
Time Frame: 24 hours
Incidence of PONV
24 hours
Time to laryngeal mask exertion
Time Frame: Intraoperative
Measured from the last surgical knot to LMA exertion
Intraoperative
Adverse effect
Time Frame: 24 hours
Severe changes in hemodynamics, including severe bradycardia, tachycardia, hypotension, hypertension, desaturation
24 hours
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

April 19, 2024

First Submitted That Met QC Criteria

April 19, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 27, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndonesiaU240201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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