Intravenous Versus Peribulbar Dexmedetomidine for Strabismus Surgery in Adults

A Comparative Study of Intravenous Versus Peribulbar Administration of Dexmedetomidine for Strabismus Surgery in Adults

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

Study Overview

• Status: Completed
• Conditions: Squint
• Intervention / Treatment: Drug: Dexmedetomidine

Detailed Description

Strabismus (misalignment of the eye) results from a difference in extraocular muscle function. Consequently, two different images, one from each eye, are transmitted to the brain, resulting in a loss of visual depth. In adults, cosmetic appearance is the main issue but sudden occurrence of strabismus may cause diplopia because the brain cannot suppress the overlapping images. The goal of strabismus surgery is to align the eyes, reduce diplopia, and restore binocular vision Ophthalmic regional block can be used as the primary anesthetic technique for strabismus surgery. The advantages of ophthalmic regional blockade include a reduced incidence of oculocardiac reflex (OCR) and emergence agitation, postoperative analgesia, and decreased postoperative nausea and vomiting (PONV).

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.

Perineural dexmedetomidine, when added to bupivacaine, has been shown to potentiate its effects, providing a better quality of anesthesia and postoperative analgesia. Intravenous (I.V.) dexmedetomidine, when used during regional anesthesia, has been shown to prolong sensory and motor blockade in addition to sedation and postoperative analgesia.

No previous studies where different routes of dexmedetomidine have been compared in adult strabismus surgery.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ahmed F gabr, phD; Phone Number: 01223496297; Email: ahmed.gabr@aswu.edu.eg

Study Locations

• Egypt
  • Aswan, Egypt, 81511
    • Aswan University Hospital
  • Aswan, Egypt, 81511
    • Huda Fahmy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. patients under the age of 20
2. uncooperative patients
3. Patients with coagulopathy
4. patients who disincline to participate in the study will be excluded from the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Peribulbar dexmedetomidine; 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; to compare perineural (peribulbar) dexmedetomidine versus intravenous (I.V.) dexmedetomidine when used as an adjuvant with local anesthesia in adult strabismus surgery.; Other Names: alpha-2 agonist
Active Comparator: Intravenous dexmedetomidine; 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; to compare perineural (peribulbar) dexmedetomidine versus intravenous (I.V.) dexmedetomidine when used as an adjuvant with local anesthesia in adult strabismus surgery.; Other Names: alpha-2 agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of motor block	Time lapse between complete injection of local anesthesia till complete abolishment of ocular motility (akinesia)	40 minutes
duration of motor block	Time lapse between complete abolishment of ocular motility (akinesia) till fully returned of ocular motility and disappearance of diplopia	8 hours
onset of sensory block	the time lapse between the complete injection of local anesthetics and the abolishment of sensation using gauze soaked with iced normal saline / Corneal reflex.	20 minutes
duration of sensory block	defined as the time lapse between the abolishment of sensation using gauze soaked with iced normal saline / corneal reflex and the commencement of postoperative pain.	10 hours

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 520/3/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No