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Dexmedetomidine as an Adjuvant for Sub-Tenon's Anesthesia

Information source: Magrabi Eye & Ear Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vitreoretinal Surgery Under Sub-Tenon's Anesthesia

Intervention: dexmedetomidine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Magrabi Eye & Ear Hospital

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.

Clinical Details

Official title: The Effect of a Low-dose Dexmedetomidine as an Adjuvant to Levobupivacaine in Patients Undergoing Vitreoretinal Surgery Under Sub-Tenon's Anesthesia

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Screening

Primary outcome: the motor and sensory block durations

Secondary outcome: sleep quality of the 1st postoperative night

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).

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

inclusion criteria:

- satisfactory akinesia

- predictable surgical time to be less than 3 hours were inclusion criteria for this

study Exclusion Criteria:

- 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.

Locations and Contacts

Additional Information

Starting date: January 2014
Last updated: December 29, 2014

Page last updated: August 23, 2015

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