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Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation

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ClinicalTrials.gov Identifier: NCT02256358
Recruitment Status : Completed
First Posted : October 3, 2014
Results First Posted : October 9, 2014
Last Update Posted : October 20, 2014
Sponsor:
Information provided by (Responsible Party):
Ki Hwa Lee, Inje University

Brief Summary:
Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia

Condition or disease Intervention/treatment Phase
Psychomotor Agitation Drug: Midazolam Drug: Ketamine Not Applicable

Detailed Description:
Emergence agitation is self-limiting aggressive behavior that develops in the early period of awakening from anesthesia. A high level of preoperative anxiety is a risk factor for emergence agitation using Aono's four-point scale. Midazolam and ketamine was administered to the patients to decrease of preoperative anxiety. We aimed to compare the emergence agitation between midazolam group and ketamine group.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation : a Randomized Controlled Trial
Study Start Date : January 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Midazolam
Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.
Drug: Midazolam
preoperatively injected intravenous 0.1 mg/kg midazolam

Experimental: Ketamine
Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.
Drug: Ketamine
Preoperatively injected intravenous 1mg/kg ketamine
Other Name: Ketamine HCl




Primary Outcome Measures :
  1. Emergence Agitation [ Time Frame: During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes ]
    The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.



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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American society of anesthesiologists physical status 1-2 aged 2-6 years old, who were scheduled to undergo ophthalmic surgery (<2hr)

Exclusion Criteria:

  • children with central nervous system disorders,history of allergy to the study drugs (midazolam and ketamine), history of recent respiratory tract infection

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): NCT02256358


Sponsors and Collaborators
Inje University
Investigators
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Study Chair: Kihwa Lee, MD Haeundae paik hospital, inje university

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Responsible Party: Ki Hwa Lee, Assistant professor, Inje University
ClinicalTrials.gov Identifier: NCT02256358     History of Changes
Other Study ID Numbers: 2012-127
First Posted: October 3, 2014    Key Record Dates
Results First Posted: October 9, 2014
Last Update Posted: October 20, 2014
Last Verified: October 2014
Keywords provided by Ki Hwa Lee, Inje University:
child, ketamine, midazolam
Additional relevant MeSH terms:
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Ketamine
Psychomotor Agitation
Emergence Delirium
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Delirium
Confusion
Postoperative Complications
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Midazolam
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia