Use of Preanesthetic Dexmedetomidine in Elderly, Treated-hypertensive Patients

NCT ID: NCT02768610

Last Updated: 2016-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-05-31

Brief Summary

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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

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Conditions

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Perioperative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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dexmedetomidine

0.5 mcg/kg dexmedetomidine is administered before endotracheal intubation for 10 minutes

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Normal Saline

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Interventions

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Dexmedetomidine

Intervention Type DRUG

Normal Saline

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DongGuk University

OTHER

Sponsor Role lead

Responsible Party

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Chanwoo Lee

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miwoon Kim, M.D., Ph.D.

Role: STUDY_DIRECTOR

DongGuk universit hospital Gyeongju hospital

Other Identifiers

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110757-201602-HR-03-03

Identifier Type: -

Identifier Source: org_study_id

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