Comparison of Dexmedetomidine, Remifentanil and Lidocaine for the Effect on Airway Reflex and Hemodynamic Response During Emergence in Patients Undergoing Craniotomy
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Open Craniotomy |
Drug: remifentanil Drug: dexmedetomidine with remifentanil Drug: lidocaine with remifentanil |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Comparison of Dexmedetomidine, Remifentanil and Lidocaine for the Effect on Airway Reflex and Hemodynamic Response During Emergence in Patients Undergoing Craniotomy |
- cough incidence [ Time Frame: 1 minute after extubation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 112 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Remifentanil group
Remifentanil group : remifentanil effect site-TCI 2-4ng/ml
|
Drug: remifentanil
remifentanil effect site-TCI 2-4ng/ml
|
|
Active Comparator: lidocaine group
lidocaine group : remifentanil effect site-TCI 2-4ng/ml + lidocaine 1.5mg/kg
|
Drug: lidocaine with remifentanil
remifentanil effect site-TCI 2-4ng/ml with lidocaine 1.5mg/kg
|
|
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
|
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Korea, Republic of | |
| Severance Hospital | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Seung-Ho Choi, MD, Ph.D 82-2-2227-3833 csho99@yuhs.ac | |
| Contact: Hyun-Zu Kim, MD 82-2-2227-4244 ANESHYUNZU@yuhs.ac | |
More Information
No publications provided
| Responsible Party: | Yonsei University |
| ClinicalTrials.gov Identifier: | NCT01365923 History of Changes |
| Other Study ID Numbers: | 1-2011-0019 |
| Study First Received: | May 31, 2011 |
| Last Updated: | January 31, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Additional relevant MeSH terms:
|
Lidocaine Remifentanil Dexmedetomidine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents |
Cardiovascular Agents Hypnotics and Sedatives Analgesics, Non-Narcotic Analgesics Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Anesthetics, Intravenous Anesthetics, General |
ClinicalTrials.gov processed this record on May 21, 2013