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Comparison Between Remifentanil Target-controlled Infusion and Dexmedetomidine Bolus Administration for Smooth Emergence From General Sevoflurane Anesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01617694
First received: June 5, 2012
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  Purpose

Remifentanil target-controlled infusion and dexmedetomidine single-dose administration are known to reduce airway response and haemodynamic stimulation during anaesthetic recovery. The investigators will compare the effects of two drugs on prevention of cough during emergence from general sevoflurane anaesthesia.


Condition Intervention
Thyroid Neoplasm
 Drug: dexmedetomidine
Drug: Normal Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • coughing response [ Time Frame: from discontinuation of anesthetic agent (sevoflurane) to 5 min after extubation. ] [ Designated as safety issue: No ]
    Emergence cough was defined as the cough occurrence during peri-extubation period, from sevoflurane discontinuation to 5 min after extubation. The severity of cough was assessed and recorded by the following cough grading system: Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).


Enrollment: 65
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group R
continuation of remifentanil target controlled infusion (TCI) at effect-site concentration of 2 ng/ml during anesthetic recovery until extubation.
 Drug: dexmedetomidine
Fifteen minutes before the end of surgery, the first practitioner replace the syringe of remifentanil as new one; new syringe contains remifentanil in remifentanil group (Group R), and normal saline in dexmedetomidine group (Group D), respectively. There are no drug labeling in the new syringe, so the second practitioner can't know which drug was contained in the new syringe. Simultaneously, the second practitioner remifentanil concentration on monitor of TCI pump will be adjusted to 2.0 ng•ml-1. Ten minutes before the end of surgery, 10 ml of dexmedetomidine 0.5 mcg•kg-1 mixed with normal saline will be given for 5 min in Group D; in Group R, 10 ml of normal saline will be given by the first practitioner.
Drug: Normal Saline
Active Comparator: group D
remifentanil TCI discontinuation and dexmedetomidine 0.5 mg/kg intravenous injection before 10 min of the end of surgery
 Drug: dexmedetomidine
Fifteen minutes before the end of surgery, the first practitioner replace the syringe of remifentanil as new one; new syringe contains remifentanil in remifentanil group (Group R), and normal saline in dexmedetomidine group (Group D), respectively. There are no drug labeling in the new syringe, so the second practitioner can't know which drug was contained in the new syringe. Simultaneously, the second practitioner remifentanil concentration on monitor of TCI pump will be adjusted to 2.0 ng•ml-1. Ten minutes before the end of surgery, 10 ml of dexmedetomidine 0.5 mcg•kg-1 mixed with normal saline will be given for 5 min in Group D; in Group R, 10 ml of normal saline will be given by the first practitioner.
Drug: Normal Saline

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female patient,
  • aged 20-60 yr,
  • ASA physical status 1-2,
  • patients undergoing elective thyroidectomy under general anesthesia

Exclusion Criteria:

  • sighs of difficult airway,
  • history of respiratory disease or chronic cough,
  • cardiovascular disease,
  • pregnant or breast-feeding woman.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617694

Locations
Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Publications:

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01617694     History of Changes
Other Study ID Numbers: 4-2011-0181
Study First Received: June 5, 2012
Last Updated: June 11, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Yonsei University:
dexmedetomidine
remifentanil
target-controlled infusion

Additional relevant MeSH terms:
Neoplasms
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Dexmedetomidine
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 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
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 21, 2013