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Completed

NCT Number: NCT02768610

Use of Preanesthetic Dexmedetomidine in Elderly, Treated-hypertensive Patients

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.

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Key information

Conditions

Perioperative Care

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dexmedetomidine

Drug

normal saline

Drug

Primary outcomes

  1. Changes in systolic blood pressure

    Time frame: 2 minutes before intubation and 1, 3, 5 minutes after intubation

    Units of Measure : mmHg

  2. Changes in diastolic blood pressure

    Time frame: 2 minutes before intubation and 1, 3, 5 minutes after intubation

    Units of Measure : mmHg

  3. Changes in mean arterial pressure

    Time frame: 2 minutes before intubation and 1, 3, 5 minutes after intubation

    Units of Measure : mmHg

  4. Changes in heart rate

    Time frame: 2 minutes before intubation and 1, 3, 5 minutes after intubation

    Units of Measure : beats/min

Sponsors and collaborators

Lead sponsor

DongGuk University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 11, 2016
Registry last updated
May 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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