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

NCT01365923 | Completed Phase 4 DMC

• 1 other identifier: 1-2011-0019
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• cough incidence

  1 minute after extubation

Study Arms (2)

Remifentanil group

ACTIVE COMPARATOR

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

Drug: remifentanil

Dexmedetimidine group

ACTIVE COMPARATOR

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

Drug: dexmedetomidine with remifentanil

Interventions

remifentanil DRUG

remifentanil effect site-TCI 2-4ng/ml

Remifentanil group

dexmedetomidine with remifentanil DRUG

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

Dexmedetimidine group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Remifentanil; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 3, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 1, 2014

Record last verified: 2013-11

Locations

KR (1)