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

NCT01871129 | Completed Phase 4 DMC

• 1 other identifier: R13046M
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Dexmedetomidine; Postoperative Period; Airway extubation; Systolic Pressure

Outcome Measures

Primary Outcomes (1)

• Highest value of systolic blood pressure during extubation period

  The values of this variable will be collected from the point when propofol infusion is cut. This data will be used to estimate the base level of SAP for further analysis within this study.

  Starting five minutes before the extubation, lasting up to 1.5 hours.

Secondary Outcomes (1)

• Risk index calculated from systolic blood pressure value and time spent in that value.

  Starting at the point when propofol infusion is halted and lasting up to three hours after extubation.

Study Arms (2)

Saline group

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.

Other: Saline (placebo)

Dexmedetomidine group

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.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine 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.

Also known as: Dexdor

Dexmedetomidine group

Saline (placebo) OTHER

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

Also known as: Saline 0,9%, Normal saline

Saline group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

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

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Hypertension

Interventions

Dexmedetomidine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Kati M Järvelä, MD PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: June 6, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 30, 2014
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

FI (1)