NCT01289769

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2011

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 15, 2011

Status Verified

December 1, 2011

Enrollment Period

9 months

First QC Date

February 1, 2011

Last Update Submit

December 14, 2011

Conditions

Intubation ComplicationTracheal Intubation MorbidityAnesthesia Intubation ComplicationHypertensionHigh Blood PressureTachycardia

Outcome Measures

Primary Outcomes (4)

  • change in systolic blood pressure

    direct arterial pressure monitoring

    (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation

  • change in diastolic blood pressure

    direct arterial pressure monitoring

    (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation

  • change in mean arterial pressure

    direct arterial pressure monitoring

    (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation

  • change in heart rate

    (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

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

Study Arms (2)

dexmedetomidine

ACTIVE COMPARATOR
Drug: Dexmedetomidine

control

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DexmedetomidineDRUG

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

Also known as: Precedex
dexmedetomidine
PlaceboDRUG

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

control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA Physical Status I-III
  • Undergoing Elective Thoracotomy or Thoracoscopy
  • Required Left Sided-double Lumen Endotracheal Intubation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiang Mai University Hospital

Maung, Chiang Mai, 50200, Thailand

Location

Related Publications (3)

  • 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.

    PMID: 18929283BACKGROUND

  • 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.

    PMID: 11284817BACKGROUND

  • 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.

    PMID: 23983684DERIVED

MeSH Terms

Conditions

HypertensionTachycardia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Tanyong Pipanmekaporn, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology, Faculty of Medicine

Study Record Dates

First Submitted

February 1, 2011

First Posted

February 4, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 15, 2011

Record last verified: 2011-12

Locations

TH(1)