Skip to main content
OpenTrials
Completed

NCT Number: NCT01365923

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Remifentanil

Drug

remifentanil effect site-TCI 2-4ng/ml

dexmedetomidine with remifentanil

Drug

remifentanil effect site-TCI 2-4ng/ml with dexmedetomidine 0.5mcg/kg

Primary outcomes

  1. cough incidence

    Time frame: 1 minute after extubation

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 3, 2011
Registry last updated
Jul 1, 2014

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.