Intravenous Versus Peribulbar Dexmedetomidine for Strabismus Surgery in Adults

NCT05215158 | Completed

• 1 other identifier: 520/3/21
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

Using various adjuvants has become a trend in regional anesthesia practice to improve the quality of anesthesia and prolong postoperative analgesia. Dexmedetomidine, an alpha-2 agonist has been proposed as a safe and effective adjunct capable of extending the duration of the single-shot block

Conditions

Squint

Outcome Measures

Primary Outcomes (1)

• duration of analgesia

  The time gap between the abolition of the sensation using gauze soaked in cooled normal saline, or corneal reflex, and the first postoperative demand for analgesia

  12 hours

Study Arms (2)

Peribulbar dexmedetomidine

ACTIVE COMPARATOR

The peribulbar block will be done using a mixture of 4 ml Lidocaine 2%, 4 ml Bupivacaine 0.5%, and 2 ml normal saline containing 50 μg dexmedetomidine perineurally (30 patients).

Drug: Dexmedetomidine

Intravenous dexmedetomidine

ACTIVE COMPARATOR

The peribulbar block will be done using a mixture of 4 ml Lidocaine 2%, 4 ml Bupivacaine 0.5%, and 2 ml normal saline. Patients received 50 μg dexmedetomidine in 50 mL of normal saline administered as an infusion over 10 minutes, and given 10 minutes before the peribulbar block (30 patients).

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

to compare perineural (peribulbar) dexmedetomidine versus intravenous (I.V.) dexmedetomidine when used as an adjuvant with local anesthesia in adult strabismus surgery.

Also known as: alpha-2 agonist

Intravenous dexmedetomidine; Peribulbar dexmedetomidine

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patient planned to perform a unilateral strabismus surgery
• Age: 20-60 years
• American Society of Anesthesiologists class I and II

You may not qualify if:

• patients under the age of 20
• uncooperative patients
• Patients with coagulopathy
• patients who disincline to participate in the study will be excluded from the study

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (2)

Aswan University Hospital

Aswān, 81511, Egypt

Location

Huda Fahmy

Aswān, 81511, Egypt

Location

Related Publications (1)

• Ghazaly HF, Hassan IE, Gabr AF, Dardeer TT, Alazhary MA. Intravenous Versus Peribulbar Dexmedetomidine as an Adjunct to Local Anesthetics in Strabismus Surgery: A Randomized, Double-blinded Clinical Trial. Pain Physician. 2024 Nov;27(8):E819-E827.

  PMID: 39621979 DERIVED

MeSH Terms

Conditions

Strabismus

Interventions

Dexmedetomidine; Adrenergic alpha-2 Receptor Agonists

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Study Start: January 28, 2022
• Primary Completion: July 1, 2023
• Study Completion: September 15, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

EG (2)