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

The Effect of Prophylactic Dexmedetomidine on Hemodynamic Disturbances During Double Lumen Endotracheal Intubation. A Double-blinded, Randomized, Placebo-Controlled Trial.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01289769

Enrollment

Registered

2011-02-04

Start date

2011-03-31

Completion date

2011-12-31

Last updated

2011-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Intubation Complication, High Blood Pressure, Hypertension, Intubation Complication, Tachycardia, Tracheal Intubation Morbidity

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.

Interventions

DRUGDexmedetomidine

dexmedetomidine 0.7 microgram per kilogram in saline 20 ml given within 10 minutes before intubation

DRUGPlacebo

normal saline 20 ml( the same volume as dexmedetomidine) giving within 10 minutes.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026