Intravenous Versus Peribulbar Dexmedetomidine for Strabismus Surgery in Adults

NCT ID: NCT05215158

Last Updated: 2023-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-28

Study Completion Date

2023-09-15

Brief Summary

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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

Detailed Description

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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.

Conditions

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Squint

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

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).

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Other Intervention Names

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alpha-2 agonist

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aswan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Huda Fahmy Mahmoud, PhD

Assistant professor of Anesthesia and Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aswan University Hospital

Aswān, , Egypt

Site Status

Huda Fahmy

Aswān, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 39621979 (View on PubMed)

Other Identifiers

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520/3/21

Identifier Type: -

Identifier Source: org_study_id

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