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.

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Tachycardia; Intubation Complication; Anesthesia Intubation Complication; Tracheal Intubation Morbidity; High Blood Pressure
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai
    • Maung, Chiang Mai, Thailand, 50200
      • Chiang Mai University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control	Drug: Placebo; normal saline 20 ml( the same volume as dexmedetomidine) giving within 10 minutes.
Active Comparator: dexmedetomidine	Drug: Dexmedetomidine; dexmedetomidine 0.7 microgram per kilogram in saline 20 ml given within 10 minutes before intubation; Other Names: Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
change in heart rate		(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Investigators: Principal Investigator: Tanyong Pipanmekaporn, MD, Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 1, 2011
• First Submitted That Met QC Criteria: February 3, 2011
• First Posted (Estimate): February 4, 2011

Study Record Updates

• Last Update Posted (Estimate): December 15, 2011
• Last Update Submitted That Met QC Criteria: December 14, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Hypertension; Tachycardia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: COM-10-11-19B-11; research ID 77 (Other Identifier: Research ID 77)