Clinical trial NCT01289769: The Effect of Dexmedetomidine on Hemodynamic Response During Double Lumen Endotracheal Intubation
Official title: The Effect of Prophylactic Dexmedetomidine on Hemodynamic Disturbances During Double Lumen Endotracheal Intubation. A Double-blinded, Randomized, Placebo-Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intubation Complication
Tracheal Intubation Morbidity
Anesthesia Intubation Complication
Hypertension
High Blood Pressure
Tachycardia
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2011-02-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in systolic blood pressure
timeFrame: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
measure: change in diastolic blood pressure
timeFrame: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
measure: change in mean arterial pressure
timeFrame: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
measure: change in heart rate
timeFrame: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
Secondary outcomes:
measure: adverse events related to dexmedetomidine
timeFrame: (day 1) during dexmedetomidine administration until 10 minutes after endotracheal intubation
Other outcomes:
Locations:
city: Maung
country: Thailand
facility: Chiang Mai University Hospital
state: Chiang Mai
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200
name: Tanyong Pipanmekaporn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1046/j.1365-2044.2001.01917.x.
citation: Pipanmekaporn T, Punjasawadwong Y, Charuluxananan S, Lapisatepun W, Bunburaphong P. The effect of prophylactic dexmedetomidine on hemodynamic disturbances to double-lumen endotracheal intubation: a prospective, randomized, double-blind, and placebo-controlled trial. Anesthesiol Res Pract. 2013;2013:236089. doi: 10.1155/2013/236089. Epub 2013 Jul 29.