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The Effects of Dexmedetomidine to Postoperative Awakening and Extubation-related Changes in Blood Pressure

NCT01871129 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-05-05

No results posted yet for this study

Summary

The postoperative removal of intubation tube induces a noticeable sympathic response and increase of blood pressure. The risk of complications is especially elevated with the patients having cardiac surgery. Though sedation inhibits the sympathetic responses to extubation, according to the current protocol the propofol infusion has to be discontinued well before extubation because of its inhibitory effects on breathing centers.

Dexmedetomidine is relatively new anesthesia drug. Dexmedetomidine is unique in its characteristic that it does not have the paralyzing effect on breathing. The aim of our study is to work out whether dexmedetomidine-extended propofol sedation over the extubation diminishes the aforementioned harmful effects of the extubation procedure.

Study design is prospective double-blinded randomized study. The investigators compare two groups of 25 patients (total 50), who are of 60-90 years of age and are having either aortic valve surgery or the mentioned accompanied with cardiopulmonary bypass operation. The first group receives dexmedetomidine infusion and the other receives placebo infusion after the end of propofol infusion.

The specific goal of the study is to figure what haemodynamic - mostly blood pressure related - changes can be observed when the postoperatively cut propofol infusion is continued with dexmedetomidine over the extubation procedure.

Our hypothesis is that by using dexmedetomidine supplemented sedation the normally notifiable peak in blood pressure may be avoided.

The study will be carried out completely in Cardiac ICU in Tampere University Hospital.

Conditions

Interventions

DRUG

Dexmedetomidine

Dexmedetomidine will be diluted into a saline solution to a recommended concentration of 4 micrograms per millilitre. The saline will then be initially administered at the rate of 0.5 micrograms/kg/h and from that point the amount will be reduced to the point where the patient breathes well and is calm (compare dexmedetomidine recommendation at 0.2-1.4 ug/kg/h). The infusion rate will then be approximately 1-10 ml/h for a patient of 80 kgs weight. The exact dosage cannot be predetermined because it differs in each individual. In the control group the infusion speed is matching.

OTHER

Saline (placebo)

Saline placebo infusion will be adjusted the same fashion as the active comparator drug.

Sponsors & Collaborators

  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Kati M Järvelä, MD PhD · TAYS Sydänkeskus Oy (Heart Center CO. Tampere University Hospital)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Finland

Study Locations

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Entities

Diseases

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 NCT01871129 on ClinicalTrials.gov