CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 150 target
Drug / intervention
spinal dexmedetomidine 0.5 mcg +2 moredrug
Likely dose
spinal dexmedetomidine 0.5 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02282319
NCT02282319Phase 4Completed

Influence of Spinal or Intravenous Dexmedetomidine on Spinal Anesthesia With Chloroprocaine and Bladder Function in Day-case Surgery. A Double Blind Randomized Study.

University Hospital, Antwerp·interventional·Posted Nov 4, 2014·Updated Aug 5, 2022

In Brief

A Phase 4 clinical trial evaluating spinal dexmedetomidine 0.5 mcg, spinal chloroprocaine 40 mg, and 1 other intervention for Surgery Ambulatory. Completed, enrolled 150 participants across 2 sites.

Detailed Summary

The primary objective of this double blind randomized study is to determine the effect of dexmedetomidine on onset and duration of the sensory and motor block and on the influence on bladder function after spinal anesthesia with chloroprocaine. Our primary hypothesis is that sensory block will significantly be prolonged by dexmedetomidine administered by both the spinal and the intravenous route. The investigators do not expect a significant difference in motor block duration between intravenous or spinal administration. Secondary outcomes are micturition problems, duration of analgesia and the occurrence of side effects such as sedation and hypotension.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 4, 2014
Enrollment StartOct 1, 2014
Primary CompletionDec 1, 2020
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 11.7 years ago

Interventions

spinal dexmedetomidine 0.5 mcgdrug

Administration of dexmedetomidine 0.5 mcg

spinal chloroprocaine 40 mgother

spinal anesthesia with chloroprocaine 40 mg

IV dexmedetomidine 0.5 mcg/kgdrug

intravenous administration of dexmedetomidine 0.5 mcg/kg