Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery

NCT06382831 | Not Yet Recruiting Phase 2

• 1 other identifier: IndonesiaU240201
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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

Conditions

Anesthesia and Analgesia; Anesthesia, Endotracheal

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Postoperative nausea and vomiting (PONV)

  Incidence of PONV

  24 hours

• Pain score

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

  24 hours

• Time to laryngeal mask exertion

  Measured from the last surgical knot to LMA exertion

  Intraoperative

• Adverse effect

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

  24 hours

Study Arms (2)

Control

ACTIVE COMPARATOR

Drug: Fentanyl

Opioid free anesthesia

EXPERIMENTAL

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Opioid free anesthesia

Opioid free anesthesia

Fentanyl DRUG

Control given Opioid balanced anesthesia

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physical status of ASA 1-2
• Undergo elective ophthalmology surgery under general anesthesia with laryngeal mask insertion
• BMI 17.5-34.9

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

MeSH Terms

Conditions

Agnosia; Vomiting

Interventions

Dexmedetomidine; Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: June 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share