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

NCT ID: NCT01365923

Last Updated: 2014-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-09-30

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.

Conditions

Open Craniotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Remifentanil group

Remifentanil group : remifentanil effect site-TCI 2-4ng/ml

Group Type: ACTIVE_COMPARATOR

remifentanil

Intervention Type: DRUG

remifentanil effect site-TCI 2-4ng/ml

Dexmedetimidine group

Dexmedetomidine group: remifentanil effect site-TCI 2-4ng/ml + dexmedetomidine 0.5mcg/kg

Group Type: ACTIVE_COMPARATOR

dexmedetomidine with remifentanil

Intervention Type: DRUG

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

Interventions

remifentanil

remifentanil effect site-TCI 2-4ng/ml

Intervention Type: DRUG

dexmedetomidine with remifentanil

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1-2011-0019

Identifier Type: -

Identifier Source: org_study_id