The Effect of Dexmedetomidine on Hemodynamic Response During Double Lumen Endotracheal Intubation

Phase 2

Completed

• Conditions: Intubation Complication; Tracheal Intubation Morbidity; Anesthesia Intubation Complication; Hypertension; High Blood Pressure; Tachycardia
• Interventions: Drug: Dexmedetomidine; Drug: Placebo

• Registration Number: NCT01289769
• Lead Sponsor: Chiang Mai University

Brief Summary

The purpose of this study is to evaluate the effect of dexmedetomidine on hemodynamic responses during laryngoscopy and double lumen endotracheal intubation and assess the adverse effect related to complications of dexmedetomidine.

Detailed Description

The cardiovascular responses to laryngoscopy and tracheal intubation are mediated by both sympathetic and parasympathetic nervous system. The hemodynamic responses resulting from sympathetic nervous system stimulation are tachycardia, cardiac arrhythmias, hypertension, increased intraocular pressure, increased intracranial pressure, bronchospasm and myocardial ischemia. Tachycardia is one of the major predictor of intraoperative myocardial ischemia and causes an imbalance of myocardial oxygen supply and demand. Although hemodynamic responses to laryngoscopy and intubation is transient, these effect may be harmful to patients suffering from myocardial and cerebrovascular diseases. The placement of double lumen endotracheal tube may produce similar or greater pressor response than endotracheal tube because of larger sizes and greater carinal stimulation.

Study Timeline

• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-04
• Study Start: 2011-03
• Status Verified: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2011-12-14
• Last Update Posted: 2011-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA Physical Status I-III
• Undergoing Elective Thoracotomy or Thoracoscopy
• Required Left Sided-double Lumen Endotracheal Intubation

Exclusion Criteria

• Patients with bradycardia (heart rate < 50 beat per minute) or heart block
• Suspected of Difficult Intubation
• Patients Who Are at Risk for Rapid Change of Hemodynamics
• Allergic to Dexmedetomidine
• Hepatic or Renal Impairment (Preoperative Serum Creatinine > 1.5 mg/dl)
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine	Dexmedetomidine	-
control	Placebo	-

Primary Outcome Measures

Name	Time	Method
change in systolic blood pressure	(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation	direct arterial pressure monitoring
change in diastolic blood pressure	(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation	direct arterial pressure monitoring
change in mean arterial pressure	(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation	direct arterial pressure monitoring
change in heart rate	(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation

Secondary Outcome Measures

Name	Time	Method
adverse events related to dexmedetomidine	(day 1) during dexmedetomidine administration until 10 minutes after endotracheal intubation	bradycardia, hypotension, arrhythmia

Trial Locations

Locations (1)

Chiang Mai University Hospital; 🇹🇭 Maung, Chiang Mai, Thailand