Use of Preanesthetic Dexmedetomidine in Elderly, Treated-hypertensive Patients

May 9, 2016 updated by: Chanwoo Lee, DongGuk University

Effects of Preanesthetic Dexmedetomidine on Hemodynamic Responses to Endotracheal Intubation in Elderly Patients Being Treated for Hypertension: A Randomized Trial

Background: Dexmedetomidine is an alpha 2 adrenergic agonist with sedative, anxiolytic, and analgesic properties. This study was designed to evaluate the inhibitory effects of preoperative 0.5 μg/kg dexmedetomidine on hemodynamic responses caused by endotracheal intubation in elderly patients being treated for hypertension.

Methods: Forty elderly (≥ 65 years) treated-hypertensive patients of American Society of Anesthesiologists physical status II undergoing elective noncardiac surgery were randomly and assigned to two groups. Group C received normal saline and group D received 0.5 μg/kg dexmedetomidine intravenously over 10 min just before endotracheal intubation. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and heart rate (HR) were recorded preoperatively at ward, immediately after study drug administration, and at 1, 3, and 5 minutes after endotracheal intubation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists physical status II
  • Scheduled for elective noncardiac surgery
  • Being treated with anti-hypertensive medication

Exclusion Criteria:

  • Endotracheal intubation attempted more than twice
  • Morbidly obese (BMI > 35 kg/m2)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Normal Saline
Drug: Normal Saline
Experimental: dexmedetomidine
0.5 mcg/kg dexmedetomidine is administered before endotracheal intubation for 10 minutes
Drug: Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in systolic blood pressure
Time Frame: 2 minutes before intubation and 1, 3, 5 minutes after intubation
Units of Measure : mmHg
2 minutes before intubation and 1, 3, 5 minutes after intubation
Changes in diastolic blood pressure
Time Frame: 2 minutes before intubation and 1, 3, 5 minutes after intubation
Units of Measure : mmHg
2 minutes before intubation and 1, 3, 5 minutes after intubation
Changes in mean arterial pressure
Time Frame: 2 minutes before intubation and 1, 3, 5 minutes after intubation
Units of Measure : mmHg
2 minutes before intubation and 1, 3, 5 minutes after intubation
Changes in heart rate
Time Frame: 2 minutes before intubation and 1, 3, 5 minutes after intubation
Units of Measure : beats/min
2 minutes before intubation and 1, 3, 5 minutes after intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DongGuk University

Investigators

  • Study Director: Miwoon Kim, M.D., Ph.D., DongGuk universit hospital Gyeongju hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 5, 2016

First Submitted That Met QC Criteria

May 9, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 9, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110757-201602-HR-03-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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