Dexmedetomidine as an Adjuvant for Sub-Tenon's Anesthesia
NCT ID: NCT02327156
Last Updated: 2014-12-30
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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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2014-01-31
2014-11-30
Brief Summary
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Detailed Description
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Methods: The investigator investigated 60 patients subjected to vitreoretinal surgery under sub-Tenon's anesthesia. The patients were randomly divided equally into 1 of 2 groups conferring to the local anesthesia (LA) solution used to receive either 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU diluted with 1mL normal saline (group L) or 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU and dexmedetomidine 20 μg diluted with 1mL normal saline (group LD). The total volume of the LA solution used was 5 mL. Motor block (akinesia) and sensory block durations were evaluated until the return of normal motor and sensory function. The sedation level was assessed during the surgery period and 24 hours postoperatively together with the degree of postoperative pain and the efficiency of postoperative analgesia. The sleep quality of the first postoperative night was assessed using the Consensus Sleep Diary (CSD).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
QUADRUPLE
Study Groups
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group L
receive 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU diluted with 1mL normal saline
No interventions assigned to this group
group LD
4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU and dexmedetomidine 20 μg diluted with 1mL normal saline
dexmedetomidine
adding dexmedetomidine to the local anesthetic
Interventions
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dexmedetomidine
adding dexmedetomidine to the local anesthetic
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients with a single eye,
* history of sleep apnea,
* severe cardiac disease, and
* drug abuse or
* if there was any contraindication to LA.
18 Years
65 Years
ALL
Yes
Sponsors
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Magrabi Eye & Ear Hospital
OTHER
Responsible Party
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Ashraf M Ghali
SENIOR CONSULTANT
Other Identifiers
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MEEC-IRB-2014-1
Identifier Type: -
Identifier Source: org_study_id