Use of Preanesthetic Dexmedetomidine in Elderly, Treated-hypertensive Patients

NCT02768610 | Completed Phase 4

• 1 other identifier: 110757-201602-HR-03-03
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Perioperative Care

Keywords

dexmedetomidine

Outcome Measures

Primary Outcomes (4)

• Changes in systolic blood pressure

  Units of Measure : mmHg

  2 minutes before intubation and 1, 3, 5 minutes after intubation

• Changes in diastolic blood pressure

  Units of Measure : mmHg

  2 minutes before intubation and 1, 3, 5 minutes after intubation

• Changes in mean arterial pressure

  Units of Measure : mmHg

  2 minutes before intubation and 1, 3, 5 minutes after intubation

• Changes in heart rate

  Units of Measure : beats/min

  2 minutes before intubation and 1, 3, 5 minutes after intubation

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine

Normal Saline

PLACEBO COMPARATOR

Drug: Normal Saline

Interventions

Dexmedetomidine DRUG

dexmedetomidine

Normal Saline DRUG

Normal Saline

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• DongGuk University: lead

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Miwoon Kim, M.D., Ph.D.

  DongGuk universit hospital Gyeongju hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 11, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 11, 2016

Record last verified: 2016-05