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Trial record 40 of 185 for:    GLYCOPYRROLATE

Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine

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ClinicalTrials.gov Identifier: NCT02430272
Recruitment Status : Completed
First Posted : April 30, 2015
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
Won Joo Choe, Inje University

Brief Summary:

Anticholinergic drugs have traditionally been used for their antisialagogue properties. But use of anticholinergic drugs can interfere with thermoregulation via inhibition of the parasympathetically mediated sweat secretion. Sweating inhibition can reduce heat elimination, and children's thermoregulation depend more on sweating than adults and they can become hyperthermic when given these agents.

The investigators evaluated the fever-causing effects of adjunctive anticholinergics in children under general anesthesia using ketamine.


Condition or disease Intervention/treatment Phase
Fever Drug: Glycopyrrolate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine
Study Start Date : May 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Anticholinergic premedication
Premedication with 0.005mg/Kg of glycopyrrolate
Drug: Glycopyrrolate
Intravenously administered 0.005mg/Kg of glycopyrrolate in intervention group

No Intervention: Control group
Same volume of normal saline



Primary Outcome Measures :
  1. Body temperature [ Time Frame: every 30 minutes from base line ( up to 90min ) ]
    measured body temperature at three times in both ears and the highest value was selected.


Secondary Outcome Measures :
  1. Oral secretion (VAS) [ Time Frame: up to operative end ]
    Oral secretion during the whole procedure was recorded by the researcher



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Ages Eligible for Study:   12 Months to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) Physical Status classification I
  • underwent surgery between 8 to 9 am
  • undergoing ambulatory anesthesia with ketamine

Exclusion Criteria:

  • who required endotracheal intubation
  • who were administered with medications other than ketamine

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): NCT02430272


Locations
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Korea, Republic of
Ilsan Paik hospital
Goyang-si, Gyeonggi-do, Korea, Republic of, 411-706
Sponsors and Collaborators
Inje University
Investigators
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Study Chair: Won Joo Choe, M.D. Ph.D Inje Univ.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Won Joo Choe, M.D., Ph.D., Associate professor,, Inje University
ClinicalTrials.gov Identifier: NCT02430272     History of Changes
Other Study ID Numbers: DSC-01-choe
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: May 1, 2015
Last Verified: April 2015
Keywords provided by Won Joo Choe, Inje University:
Child
outpatient
premedication
Additional relevant MeSH terms:
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Glycopyrrolate
Fever
Body Temperature Changes
Signs and Symptoms
Ketamine
Cholinergic Antagonists
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Agents