The Effect of Dexmedetomidine on the Emergence Agitation in Nasal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
So Yeon Kim, Severance Hospital
ClinicalTrials.gov Identifier:
NCT01513772
First received: January 16, 2012
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

The investigators examined the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in nasal surgery


Condition Intervention
Airway Extubation
Drug: Dexmedetomidine
Drug: Normal saline 0.9%

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

Resource links provided by NLM:


Further study details as provided by Severance Hospital:

Primary Outcome Measures:
  • Emergence agitation [ Time Frame: 20min ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Postoperative quality of recovery [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: February 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Drug: Normal saline 0.9%
Normal saline(guess as 4㎍/mL) : 0.4㎍/kg/hr infusion until extubation
Active Comparator: Dexmedetomidine Drug: Dexmedetomidine
Dexmedetomidine(4㎍/mL) : 0.4㎍/kg/hr infusion until extubation

Detailed Description:

Emergence agitation during the immediate postanesthetic period is common. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters. Emergence agitation is common in ENT surgery. The aim of this study is to evaluate the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in adult patients undergoing nasal surgery.

  Eligibility

Ages Eligible for Study:   20 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 20,
  • ASA class I and II,
  • nasal surgery

Exclusion Criteria:

  • bradycardia (< 45 bpm),
  • heart block,
  • liver failure,
  • renal failure,
  • uncontrolled hypertension,
  • body mass index ≥ 30 kg/m2
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01513772

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Severance Hospital
  More Information

No publications provided

Responsible Party: So Yeon Kim, Clinical assistant professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT01513772     History of Changes
Other Study ID Numbers: 4-2011-0742
Study First Received: January 16, 2012
Last Updated: August 7, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Dexmedetomidine
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

ClinicalTrials.gov processed this record on July 29, 2014