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

NCT ID: NCT01289769

Last Updated: 2011-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Intubation Complication Tracheal Intubation Morbidity Anesthesia Intubation Complication Hypertension High Blood Pressure Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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dexmedetomidine

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiang Mai University

OTHER

Sponsor Role lead

Responsible Party

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Tanyong Pipanmekaporn

Department of Anesthesiology, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tanyong Pipanmekaporn, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200

Locations

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Chiang Mai University Hospital

Maung, Chiang Mai, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 18929283 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11284817 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23983684 (View on PubMed)

Other Identifiers

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research ID 77

Identifier Type: OTHER

Identifier Source: secondary_id

COM-10-11-19B-11

Identifier Type: -

Identifier Source: org_study_id