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Completed

NCT Number: NCT01289769

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chiang Mai University Hospital

Maung, Chiang Mai, 50200, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

dexmedetomidine 0.7 microgram per kilogram in saline 20 ml given within 10 minutes before intubation

Other names: Precedex

Placebo

Drug

normal saline 20 ml( the same volume as dexmedetomidine) giving within 10 minutes.

Primary outcomes

  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 outcomes

  1. adverse events related to dexmedetomidine

    Time frame: (day 1) during dexmedetomidine administration until 10 minutes after endotracheal intubation

    bradycardia, hypotension, arrhythmia

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

The Effect of Prophylactic Dexmedetomidine on Hemodynamic Disturbances During Double Lumen Endotracheal Intubation. A Double-blinded, Randomized, Placebo-Controlled Trial.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 4, 2011
Registry last updated
Dec 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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