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Spinal or Intravenous Dexmedetomidine in Ambulatory Surgery

NCT02282319 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-08-05

No results posted yet for this study

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.

Conditions

  • Surgery Ambulatory

Interventions

DRUG

spinal dexmedetomidine 0.5 mcg

Administration of dexmedetomidine 0.5 mcg

OTHER

spinal chloroprocaine 40 mg

spinal anesthesia with chloroprocaine 40 mg

DRUG

IV dexmedetomidine 0.5 mcg/kg

intravenous administration of dexmedetomidine 0.5 mcg/kg

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • margaretha breebaart, MD · University Hospital, Antwerp

  • Marcel Vercauteren, MD, PHD · University Hospital, Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02282319 on ClinicalTrials.gov