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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tanyong Pipanmekaporn, Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01289769
First received: February 1, 2011
Last updated: December 14, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Intubation Complication
Tracheal Intubation Morbidity
Anesthesia Intubation Complication
Hypertension
High Blood Pressure
Tachycardia
 Drug: Dexmedetomidine
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Prophylactic Dexmedetomidine on Hemodynamic Disturbances During Double Lumen Endotracheal Intubation. A Double-blinded, Randomized, Placebo-Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chiang Mai University:

Primary Outcome Measures:
  • change in systolic blood pressure [ Time Frame: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation ] [ Designated as safety issue: Yes ]
    direct arterial pressure monitoring

  • change in diastolic blood pressure [ Time Frame: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation ] [ Designated as safety issue: Yes ]
    direct arterial pressure monitoring

  • change in mean arterial pressure [ Time Frame: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation ] [ Designated as safety issue: Yes ]
    direct arterial pressure monitoring

  • change in heart rate [ Time Frame: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • adverse events related to dexmedetomidine [ Time Frame: (day 1) during dexmedetomidine administration until 10 minutes after endotracheal intubation ] [ Designated as safety issue: Yes ]
    bradycardia, hypotension, arrhythmia


Enrollment: 60
Study Start Date: March 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dexmedetomidine Drug: Dexmedetomidine
dexmedetomidine 0.7 microgram per kilogram in saline 20 ml given within 10 minutes before intubation
Other Name: Precedex
Placebo Comparator: control Drug: Placebo
normal saline 20 ml( the same volume as dexmedetomidine) giving within 10 minutes.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289769

Locations
Thailand
Chiang Mai University Hospital
Maung, Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
Investigators
Principal Investigator: Tanyong Pipanmekaporn, MD Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200
  More Information

Publications:

Responsible Party: Tanyong Pipanmekaporn, Department of Anesthesiology, Faculty of Medicine, Chiang Mai University
ClinicalTrials.gov Identifier: NCT01289769     History of Changes
Other Study ID Numbers: COM-10-11-19B-11, research ID 77
Study First Received: February 1, 2011
Last Updated: December 14, 2011
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Hypertension
Tachycardia
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013