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OpenTrials
Completed

NCT Number: NCT02327156

Dexmedetomidine as an Adjuvant for Sub-Tenon's Anesthesia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

adding dexmedetomidine to the local anesthetic

Other names: Precedex, 200 μg per 2 mL; Hospira, USA

Primary outcomes

  1. the motor and sensory block durations

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours

    expected to be extended in group LD

Secondary outcomes

  1. sleep quality of the 1st postoperative night

    Time frame: 24 hours

    improved the sleep quality

Sponsors and collaborators

Lead sponsor

Magrabi Eye & Ear Hospital

Other

Registry information

Official study title

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

Acronym: Precedex

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 30, 2014
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.