MedTrace Logo

Dexmetomidine Intrathecally and Intravenously Additionally to Spinal Anaesthesia, in Total Knee Arthroplasty

NCT02966249 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-11-17

No results posted yet for this study

Summary

The present study is designed to evaluate and compare the efficacy of intrathecal dexmedetomidine (DEX) as an adjuvant to Levobupivacaine in spinal anaesthesia and DEX's intravenous administration, without loading dose, additionally to spinal anaesthesia, in patients undergoing total knee arthroplasty.

Conditions

  • Neuromuscular Block

Interventions

DRUG

Levobupivacaine

3 ml Levobupivacaine 0.5% (15mg) given intrathecally

DRUG

Dexmetomidine intravenously

Continuous infusion of dexdemetomidine at a rate of 0.25 μg/kg/h given intravenously 10 min before spinal anesthesia in total knee arthroplasty

DRUG

Normal Saline added intrathecally

Normal Saline added to 5μgr dexmetomidine up to 0,5 ml given intrathecally for spinal anesthesia in total knee arthroplasty

DRUG

Normal Saline intrathecally

0,5 ml Normal Saline given intrathecally given once for spinal anesthesia in total knee arthroplasty

DRUG

Ringer's Lactate solution intravenously

Continuous infusion of Ringer's Lactate solution given intravenously, starting 10 minutes before spinal anesthesia up to the end of the operation

DRUG

Dexmetomidine intrathecally

5 μgr dexmetomidine given intrathecally once for anesthesia in total knee replacement

Sponsors & Collaborators

  • KAT General Hospital

    lead OTHER

Principal Investigators

  • Efi Stavropoulou · KAT GENERAL HOSPITAL OF ATTICA

  • Cathrin Chazapis · KAT General Hospital of Athens

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-04-30
Completion
2017-09-30

Countries

  • Greece

Study Locations

More Related Trials

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 NCT02966249 on ClinicalTrials.gov