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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289769
• Other study ID #: COM-10-11-19B-11
• Secondary ID: research ID 77
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2011
• Last updated: December 14, 2011
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Dexmedetomidine
dexmedetomidine 0.7 microgram per kilogram in saline 20 ml given within 10 minutes before intubation
• Placebo
normal saline 20 ml( the same volume as dexmedetomidine) giving within 10 minutes.

Locations

Country	Name	City	State
Thailand	Chiang Mai University Hospital	Maung	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

Basar H, Akpinar S, Doganci N, Buyukkocak U, Kaymak C, Sert O, Apan A. The effects of preanesthetic, single-dose dexmedetomidine on induction, hemodynamic, and cardiovascular parameters. J Clin Anesth. 2008 Sep;20(6):431-6. doi: 10.1016/j.jclinane.2008.04.007. — View Citation

Maguire A, Thompson JP, Guest C, Sadler PJ, Strupish JW, West KJ. Comparison of the effects of intravenous alfentanil and esmolol on the cardiovascular response to double-lumen endobronchial intubation. Anaesthesia. 2001 Apr;56(4):319-25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in systolic blood pressure	direct arterial pressure monitoring	(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
Primary	change in diastolic blood pressure	direct arterial pressure monitoring	(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
Primary	change in mean arterial pressure	direct arterial pressure monitoring	(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
Primary	change in heart rate		(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
Secondary	adverse events related to dexmedetomidine	bradycardia, hypotension, arrhythmia	(day 1) during dexmedetomidine administration until 10 minutes after endotracheal intubation