Dexmedetomidine as an Adjuvant for Sub-Tenon's Anesthesia

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02327156

Acronym

Precedex

Enrollment

Registered

2014-12-30

Start date

2014-01-31

Completion date

2014-11-30

Last updated

2014-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitreoretinal Surgery Under Sub-Tenon's Anesthesia

Keywords

Dexmedetomidine

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).

Interventions

DRUGdexmedetomidine

adding dexmedetomidine to the local anesthetic

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
sleep quality of the 1st postoperative night	24 hours	improved the sleep quality

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026