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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01289769
Recruitment Status : Completed
First Posted : February 4, 2011
Last Update Posted : December 15, 2011
Sponsor:
Information provided by (Responsible Party):

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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Study Start Date : March 2011
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

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

  2. change in diastolic blood pressure [ Time Frame: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation ]
    direct arterial pressure monitoring

  3. change in mean arterial pressure [ Time Frame: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation ]
    direct arterial pressure monitoring

  4. 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 Measures :
  1. adverse events related to dexmedetomidine [ Time Frame: (day 1) during dexmedetomidine administration until 10 minutes after endotracheal intubation ]
    bradycardia, hypotension, arrhythmia


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( Other Identifier: Research ID 77 )
First Posted: February 4, 2011    Key Record Dates
Last Update Posted: December 15, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Tachycardia
Hypertension
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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