Dexmedetomidine as an Adjuvant for Sub-Tenon's Anesthesia
- Conditions
- Vitreoretinal Surgery Under Sub-Tenon's Anesthesia
- Interventions
- Registration Number
- NCT02327156
- Lead Sponsor
- Magrabi Eye & Ear Hospital
- Brief Summary
The investigator evaluated the motor and sensory block durations and the postoperative analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered as a primary endpoint.
- Detailed Description
Background: The investigator evaluated the motor and sensory block durations and the postoperative analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered as a primary endpoint.
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
- incorporated patients younger than 18 years,
- patients with a single eye,
- history of sleep apnea,
- severe cardiac disease, and
- drug abuse or
- if there was any contraindication to LA.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group LD dexmedetomidine 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU and dexmedetomidine 20 μg diluted with 1mL normal saline
- Primary Outcome Measures
Name Time Method the motor and sensory block durations participants will be followed for the duration of hospital stay, an expected average of 24 hours expected to be extended in group LD
- Secondary Outcome Measures
Name Time Method sleep quality of the 1st postoperative night 24 hours improved the sleep quality