Intravenous Versus Peribulbar Dexmedetomidine for Strabismus Surgery in Adults
Primary Purpose
Squint
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Squint
Eligibility Criteria
Inclusion Criteria:
- The patients planned to perform a unilateral strabismus surgery
- Age: 20-60 years
- American Society of Anesthesiologists class I and II
Exclusion Criteria:
- patients under the age of 20
- Patients have systemic or bleeding disorders
- Patients with ocular or neurological problems, mental retardation, deafness, or dementia
- patients who disincline to participate in the study will be excluded from the study
Sites / Locations
- Aswan University Hospital
- Huda Fahmy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Peribulbar dexmedetomidine
Intravenous dexmedetomidine
Arm Description
Peribulbar block will done using mixture of Lidocaine 2%, bupivacaine 0.5% plus 0.5 μg / kg dexmedetomidine perineurally (30 patients).
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).
Outcomes
Primary Outcome Measures
Onset sensory block
Time lapse between complete injection of local anesthesia till abolishment of sensation using goose soaked with iced normal saline / Corneal reflex
Duration of sensory block
Time lapse between abolishment of sensation using goose soaked with iced normal saline / corneal reflex and the commencement of postoperative pain
Secondary Outcome Measures
Onset of motor block
Time lapse between complete injection of local anesthesia till complete abolishment of ocular motility (akinesia)
duration of motor block
Time lapse between complete abolishment of ocular motility (akinesia) till fully returned of ocular motility and disappearance of diplopia
Full Information
NCT ID
NCT05215158
First Posted
January 18, 2022
Last Updated
July 19, 2023
Sponsor
Aswan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05215158
Brief Title
Intravenous Versus Peribulbar Dexmedetomidine for Strabismus Surgery in Adults
Official Title
A Comparative Study of Intravenous Versus Peribulbar Administration of Dexmedetomidine for Strabismus Surgery in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 28, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squint
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peribulbar dexmedetomidine
Arm Type
Active Comparator
Arm Description
Peribulbar block will done using mixture of Lidocaine 2%, bupivacaine 0.5% plus 0.5 μg / kg dexmedetomidine perineurally (30 patients).
Arm Title
Intravenous dexmedetomidine
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
alpha-2 agonist
Intervention Description
to compare perineural (peribulbar) dexmedetomidine versus intravenous (I.V.) dexmedetomidine when used as an adjuvant with local anesthesia in adult strabismus surgery.
Primary Outcome Measure Information:
Title
Onset sensory block
Description
Time lapse between complete injection of local anesthesia till abolishment of sensation using goose soaked with iced normal saline / Corneal reflex
Time Frame
40 minutes
Title
Duration of sensory block
Description
Time lapse between abolishment of sensation using goose soaked with iced normal saline / corneal reflex and the commencement of postoperative pain
Time Frame
6hours
Secondary Outcome Measure Information:
Title
Onset of motor block
Description
Time lapse between complete injection of local anesthesia till complete abolishment of ocular motility (akinesia)
Time Frame
40 minutes
Title
duration of motor block
Description
Time lapse between complete abolishment of ocular motility (akinesia) till fully returned of ocular motility and disappearance of diplopia
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients planned to perform a unilateral strabismus surgery
Age: 20-60 years
American Society of Anesthesiologists class I and II
Exclusion Criteria:
patients under the age of 20
Patients have systemic or bleeding disorders
Patients with ocular or neurological problems, mental retardation, deafness, or dementia
patients who disincline to participate in the study will be excluded from the study
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
ZIP/Postal Code
81511
Country
Egypt
Facility Name
Huda Fahmy
City
Aswan
ZIP/Postal Code
81511
Country
Egypt
12. IPD Sharing Statement
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Intravenous Versus Peribulbar Dexmedetomidine for Strabismus Surgery in Adults
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