Intravenous Versus Peribulbar Dexmedetomidine for Strabismus Surgery in Adults

• Sponsor: Aswan University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05215158
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 8.1
• Patients Per Site: 30
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Squint	Drug: Dexmedetomidine	N/A

Detailed Description

Strabismus (misalignment of the eye/eyes) results from an imbalance in extraocular muscle function. Consequently, two different images, one from each eye, are transmitted to the brain, resulting in 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 shown to potentiate its effects, providing a better quality of anesthesia and postoperative analgesia, Intravenous (I.V.) dexmedetomidine, when used during regional anesthesia, has 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Comparative Study of Intravenous Versus Peribulbar Administration of Dexmedetomidine for Strabismus Surgery in Adults
• Actual Study Start Date: Jan 28, 2022
• Anticipated Primary Completion Date: Sep 20, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Peribulbar dexmedetomidine Peribulbar block will done using mixture of Lidocaine 2%, bupivacaine 0.5% plus 0.5 μg / kg 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 Lidocaine 2%, bupivacaine 0.5% plus 0.5 μg / kg dexmedetomidine in 50 mL of normal saline administered as an infusion over 10 min and is given 10 min before the start of 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

Outcome Measures

Primary Outcome Measures

1. Onset sensory block [40 minutes]

   Time lapse between complete injection of local anesthesia till abolishment of sensation using goose soaked with iced normal saline / Corneal reflex

2. Duration of sensory block [6hours]

   Time lapse between abolishment of sensation using goose soaked with iced normal saline / corneal reflex and the commencement of postoperative pain

Secondary Outcome Measures

1. Onset of motor block [40 minutes]

   Time lapse between complete injection of local anesthesia till complete abolishment of ocular motility (akinesia)

2. duration of motor block [8 hours]

   Time lapse between complete abolishment of ocular motility (akinesia) till fully returned of ocular motility and disappearance of diplopia

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. The patients 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. Patients have systemic or bleeding disorders

3. Patients with ocular or neurological problems, mental retardation, deafness, or dementia

4. patients who disincline to participate in the study will be excluded from the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aswan University Hospital	Aswan		Egypt	81511
2	Huda Fahmy	Aswan		Egypt	81511

Sponsors and Collaborators

• Aswan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Huda Fahmy Mahmoud, PhD, Assistant professor of Anesthesia and Intensive Care, Aswan University Hospital
• ClinicalTrials.gov Identifier: NCT05215158
• Other Study ID Numbers: 520/3/21
• First Posted: Jan 31, 2022
• Last Update Posted: Jul 27, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Strabismus; Dexmedetomidine

Study Results

No Results Posted as of Jul 27, 2022