Overview

This trial is active, not recruiting.

Condition hypertension
Treatments dexmedetomidine, saline (placebo)
Phase phase 4
Sponsor Tampere University Hospital
Start date June 2013
End date February 2017
Trial size 50 participants
Trial identifier NCT01871129, R13046M

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Placebo Comparator)
Difference from the normal protocol actualizes at the point when propofol infusion is cut off. From there on the patient in this group receives saline infusion up to the point where 15 minutes have passed after the extubation procedure.
saline (placebo) Saline 0,9%
Saline placebo infusion will be adjusted the same fashion as the active comparator drug.
(Active Comparator)
Difference from the normal protocol happens when normally the propofol infusion is cut off. From there on the patient in this group receives dexmedetomidine infusion up to the point where 15 minutes have passed after the extubation procedure.
dexmedetomidine Dexdor
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.

Primary Outcomes

Measure
Highest value of systolic blood pressure during extubation period
time frame: Starting five minutes before the extubation, lasting up to 1.5 hours.

Secondary Outcomes

Measure
Risk index calculated from systolic blood pressure value and time spent in that value.
time frame: Starting at the point when propofol infusion is halted and lasting up to three hours after extubation.

Eligibility Criteria

Male or female participants from 60 years up to 90 years old.

Inclusion Criteria: - Patient has to be scheduled for aortic valve surgery OR previous AND coronary artery bypass - Patient has to be 60 to 90 years of age Exclusion Criteria: - If a patient is unable to give informed concent to participate the study - If a patient is allergic or otherwise hypersensitive to the drug used in the study - If the patient has either insufficient kidney or insufficient liver function

Additional Information

Official title The Effects of Postoperative Dexmedetomidine Sedation to Haemodynamics During Extubation
Principal investigator Kati M Järvelä, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Tampere University Hospital.