The Effect of Dexmedetomidine on Hemodynamic Response During Double Lumen Endotracheal Intubation
Primary Purpose
Intubation Complication, Tracheal Intubation Morbidity, Anesthesia Intubation Complication
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Dexmedetomidine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Intubation Complication
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
Sites / Locations
- Chiang Mai University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
dexmedetomidine
control
Arm Description
Outcomes
Primary Outcome Measures
change in systolic blood pressure
direct arterial pressure monitoring
change in diastolic blood pressure
direct arterial pressure monitoring
change in mean arterial pressure
direct arterial pressure monitoring
change in heart rate
Secondary Outcome Measures
adverse events related to dexmedetomidine
bradycardia, hypotension, arrhythmia
Full Information
NCT ID
NCT01289769
First Posted
February 1, 2011
Last Updated
December 14, 2011
Sponsor
Chiang Mai University
1. Study Identification
Unique Protocol Identification Number
NCT01289769
Brief Title
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
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation Complication, Tracheal Intubation Morbidity, Anesthesia Intubation Complication, Hypertension, High Blood Pressure, Tachycardia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexmedetomidine
Arm Type
Active Comparator
Arm Title
control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
dexmedetomidine 0.7 microgram per kilogram in saline 20 ml given within 10 minutes before intubation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
normal saline 20 ml( the same volume as dexmedetomidine) giving within 10 minutes.
Primary Outcome Measure Information:
Title
change in systolic blood pressure
Description
direct arterial pressure monitoring
Time Frame
(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
Title
change in diastolic blood pressure
Description
direct arterial pressure monitoring
Time Frame
(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
Title
change in mean arterial pressure
Description
direct arterial pressure monitoring
Time Frame
(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
Title
change in heart rate
Time Frame
(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
Secondary Outcome Measure Information:
Title
adverse events related to dexmedetomidine
Description
bradycardia, hypotension, arrhythmia
Time Frame
(day 1) during dexmedetomidine administration until 10 minutes after endotracheal intubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanyong Pipanmekaporn, MD
Organizational Affiliation
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiang Mai University Hospital
City
Maung
State/Province
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
18929283
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.
Results Reference
background
PubMed Identifier
11284817
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.
Results Reference
background
PubMed Identifier
23983684
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.
Results Reference
derived
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The Effect of Dexmedetomidine on Hemodynamic Response During Double Lumen Endotracheal Intubation
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