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Comparison of Dexmedetomidin and Remifentanil for the Effect on Airway Reflex and Hemodynamic Response During Emergence in Patients Undergoing Craniotomy

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ClinicalTrials.gov Identifier: NCT01365923
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

During recovery from general anesthesia the stimuli of endotracheal tube lead to the coughing, hypertension, tachycardia, which can cause a serious complication. Especially the postoperative course of patients emerging from general anesthesia after intracranial surgery is frequently complicated by the occurrence of hypertension and coughing event.

It has been demonstrated that opioid, intravenous or topical lidocaine administration can attenuate the coughing reflex. Administered the opioid before emergence, it is effective to prevent cough reflex but the recovery is delayed, it was difficult to predict emergence.

However, remifentanil is an opioid widely used because of rapid context-sensitive half-life, target-controled infusion method to adequately maintain the effect site concentration could help to predict the recovery time to the alert state from the general anesthesia. It is considered proper method of continuous infusion of remifentanil for reducing emergence cough.

Dexmedetomidine , a potent alpha adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and and catecholamine response to intubation and extubation. It is thus theologically appropriate for reducing airway and circulatory reflexes during emergence from anesthesia.

In this study, the investigators used bolus dexmedetomidine immediately before extubation, and compared the effects on coughing, hemodynamic response and recovery profile to a continuous infusion of remifentanil.


Condition or disease Intervention/treatment Phase
Open Craniotomy Drug: remifentanil Drug: dexmedetomidine with remifentanil Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Comparison of Dexmedetomidin and Remifentanil for the Effect on Airway Reflex and Hemodynamic Response During Emergence in Patients Undergoing Craniotomy
Study Start Date : May 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

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Arm Intervention/treatment
Active Comparator: Remifentanil group
Remifentanil group : remifentanil effect site-TCI 2-4ng/ml
Drug: remifentanil
remifentanil effect site-TCI 2-4ng/ml

Active Comparator: Dexmedetimidine group
Dexmedetomidine group: remifentanil effect site-TCI 2-4ng/ml + dexmedetomidine 0.5mcg/kg
Drug: dexmedetomidine with remifentanil
remifentanil effect site-TCI 2-4ng/ml with dexmedetomidine 0.5mcg/kg




Primary Outcome Measures :
  1. cough incidence [ Time Frame: 1 minute after extubation ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • SA I~II, 2.aged between 20 and 70 year, 4.general anesthesia for craniectomy

Exclusion Criteria:

  • signs of an anatomical or functional abnormality in upper airway
  • URI or sore throat for recent 2 weeks
  • Congestive heart failure, Sinus Bradycardia(<50 BPM), Uncontrolled hypertension
  • Chronic obstructive lung disease, bronchial asthma

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): NCT01365923


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01365923     History of Changes
Other Study ID Numbers: 1-2011-0019
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: November 2013

Additional relevant MeSH terms:
Dexmedetomidine
Remifentanil
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
Analgesics, Opioid
Narcotics
Anesthetics, Intravenous
Anesthetics, General
Anesthetics