Subtenon and Intravenous Dexmedetomidine Effect on Patients Undergoing Cataract Surgery
NCT ID: NCT04668456
Last Updated: 2021-02-25
Study Results
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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UNKNOWN
PHASE3
75 participants
INTERVENTIONAL
2020-08-15
2021-03-30
Brief Summary
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Detailed Description
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The STBs or episcleral block was first described by Turnbull in 1884 and it was repopularized in the 1990s as a simple and safe alternative to needle-based eye blocks. The STB becomes the most widely practiced regional technique for cataract surgery, because it produces satisfactory anesthesia for most intraocular procedures, and avoids the inherent risks of needle-based blocks, such as globe perforation and optic nerve injury.
Dexmedetomidine is a selective α-2 receptor agonist that produces sedation and analgesia without causing respiratory depression. It also allows patients to respond to verbal commands during the sedation; easy conversion from sleeping to awakening is possible. Therefore, dexmedetomidine has been used as sedative in various clinical fields in intensive care unit and surgery and an adjuvant to local anesthetics.
Many studies were done to evaluate its effect as sedative or anlgesic when administered either intravenously or when added to local anesthesia in ophthalmic block. But no one, till now comparing its effect when used as adjuvant to local anesthetics or administered intravenously in subtenon block.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.
Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block.
TREATMENT
DOUBLE
Study Groups
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Group C (control group)
Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.
lidocaine 2%
subtenon injection
bupivacine 0.5%
subtenon injection
Normal saline
either subtenon or iv
Group SD (subtenon dexmedetomiine)
Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block.
Dexmedetomidine
the drug administered either subtenon ot iv
lidocaine 2%
subtenon injection
bupivacine 0.5%
subtenon injection
Normal saline
either subtenon or iv
Group ID (iv dexmedetomidine)
Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block.
Dexmedetomidine
the drug administered either subtenon ot iv
lidocaine 2%
subtenon injection
bupivacine 0.5%
subtenon injection
Interventions
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Dexmedetomidine
the drug administered either subtenon ot iv
lidocaine 2%
subtenon injection
bupivacine 0.5%
subtenon injection
Normal saline
either subtenon or iv
Eligibility Criteria
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Inclusion Criteria
* Aged 18-70 years
* Both sex
* Scheduled for elective phacoemulsification cataract surgery
Exclusion Criteria
* Impaired mental status
* Refusal of the patient
* Uncontrolled glaucoma
* Recent surgical procedure on the same eye
18 Years
70 Years
ALL
Yes
Sponsors
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Menoufia University
OTHER
Responsible Party
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ashraf magdy eskandr
assistant professor of anesthesia, icu
Locations
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Ashraf magdy Eskandr
Shibīn al Kawm, Monufia Governorate, Egypt
Osama A Elmorsy
Shibīn al Kawm, Monufia Governorate, Egypt
Sadik A Sadik
Shibīn al Kawm, Monufia Governorate, Egypt
Countries
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Other Identifiers
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8/8/2020 ANET4
Identifier Type: -
Identifier Source: org_study_id
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