Use of Preanesthetic Dexmedetomidine in Elderly, Treated-hypertensive Patients

Perioperative Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768610
• Other study ID #: 110757-201602-HR-03-03
• Status: Completed
• Phase: Phase 4
• First received: May 5, 2016
• Last updated: May 9, 2016
• Start date: March 2016
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: DongGuk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Perioperative Care

Intervention

Drug:
• Dexmedetomidine

• Normal Saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DongGuk University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in systolic blood pressure	Units of Measure : mmHg	2 minutes before intubation and 1, 3, 5 minutes after intubation	No
Primary	Changes in diastolic blood pressure	Units of Measure : mmHg	2 minutes before intubation and 1, 3, 5 minutes after intubation	No
Primary	Changes in mean arterial pressure	Units of Measure : mmHg	2 minutes before intubation and 1, 3, 5 minutes after intubation	No
Primary	Changes in heart rate	Units of Measure : beats/min	2 minutes before intubation and 1, 3, 5 minutes after intubation	No