Dexmedetomidine as an Adjuvant for Sub-Tenon's Anesthesia

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Vitreoretinal Surgery Under Sub-Tenon's Anesthesia

Intervention / Treatment
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* Drug: dexmedetomidine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: group L<br>receive 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU diluted with 1mL normal saline | |
| Active Comparator: group LD<br>4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU and dexmedetomidine 20 μg diluted with 1mL normal saline | Drug: dexmedetomidine<br>* adding dexmedetomidine to the local anesthetic<br>* Other names: Precedex, 200 μg per 2 mL; Hospira, USA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the motor and sensory block durations | expected to be extended in group LD | participants will be followed for the duration of hospital stay, an expected average of 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep quality of the 1st postoperative night | improved the sleep quality | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine