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

NCT ID: NCT01871129

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-04-30

Brief 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

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Saline group

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.

Group Type: PLACEBO_COMPARATOR

Saline (placebo)

Intervention Type: OTHER

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

Dexmedetomidine group

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.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Saline (placebo)

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

Intervention Type: OTHER

Other Intervention Names

Dexdor; Saline 0,9%; Normal saline

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kati M Järvelä, MD PhD

Role: PRINCIPAL_INVESTIGATOR

TAYS Sydänkeskus Oy (Heart Center CO. Tampere University Hospital)

Locations

TAYS Sydänkeskus Oy (Heart Center CO. Tampere University Hospital)

Tampere, , Finland

Countries

Finland

Other Identifiers

R13046M

Identifier Type: -

Identifier Source: org_study_id