Use of Preanesthetic Dexmedetomidine in Elderly, Treated-hypertensive Patients

Phase 4

Completed

• Conditions: Perioperative Care
• Interventions: Drug: Normal Saline; Drug: Dexmedetomidine

• Registration Number: NCT02768610
• Lead Sponsor: DongGuk University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2016-04
• Status Verified: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2016-05-05
• Study First Submitted QC: 2016-05-09
• Last Update Submitted: 2016-05-09
• Study First Posted: 2016-05-11
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	-
dexmedetomidine	Dexmedetomidine	0.5 mcg/kg dexmedetomidine is administered before endotracheal intubation for 10 minutes

Primary Outcome Measures

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