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The Effect of Dexmedetomidine on the Emergence Agitation in Nasal Surgery

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ClinicalTrials.gov Identifier: NCT01513772
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : August 9, 2012
Sponsor:
Information provided by (Responsible Party):
So Yeon Kim, Severance Hospital

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

Condition or disease Intervention/treatment Phase
Airway Extubation Drug: Dexmedetomidine Drug: Normal saline 0.9% Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Study Start Date : February 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

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Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Emergence agitation [ Time Frame: 20min ]

Secondary Outcome Measures :
  1. Postoperative quality of recovery [ Time Frame: 1 day ]


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Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513772


Locations
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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

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Responsible Party: So Yeon Kim, Clinical assistant professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT01513772     History of Changes
Other Study ID Numbers: 4-2011-0742
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: August 9, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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