NCT02327156

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

7 months

First QC Date

December 18, 2014

Last Update Submit

December 29, 2014

Conditions

Vitreoretinal Surgery Under Sub-Tenon's Anesthesia

Keywords

Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • sleep quality of the 1st postoperative night

    24 hours

Study Arms (2)

group L

NO INTERVENTION

receive 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU diluted with 1mL normal saline

group LD

ACTIVE COMPARATOR

4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU and dexmedetomidine 20 μg diluted with 1mL normal saline

Drug: dexmedetomidine

Interventions

dexmedetomidineDRUG

adding dexmedetomidine to the local anesthetic

Also known as: Precedex, 200 μg per 2 mL; Hospira, USA
group LD

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • satisfactory akinesia

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SENIOR CONSULTANT

Study Record Dates

First Submitted

December 18, 2014

First Posted

December 30, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2014

Study Completion

November 1, 2014

Last Updated

December 30, 2014

Record last verified: 2014-12