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Temperature Changes During Induction of General Anesthesia in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00710320
First received: July 3, 2008
Last updated: February 3, 2010
Last verified: February 2010
History of Changes
  Purpose

We aim that uncovering patients during induction of general anesthesia does not decrease core body temperature in pediatric patients.


Condition Intervention
Hypothermia
 Procedure: Covered and uncovered anesthesia induction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Temperature Changes During Induction of General Anesthesia in Pediatric Patients

Resource links provided by NLM:

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Covered group during induction of general anesthesia will be greater by 0.5ºC than the uncovered group during induction of general anesthesia. [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Covered and uncovered, will be equal during surgery and post-operatively. In other words, due to the active warming procedures during surgery and post-operatively in the PICU, core temperatures of the uncovered group will catch up to the covered group. [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cover and Uncover
Procedure/Surgery
 Procedure: Covered and uncovered anesthesia induction

We hypothesize that the core temperatures of:

  1. the covered group during induction of general anesthesia will be greater by 0.5ºC than the uncovered group during induction of general anesthesia.
  2. both groups, covered and uncovered, will be equal during surgery and post-operatively. In other words, due to the active warming procedures during surgery and post-operatively in the PICU, core temperatures of the uncovered group will catch up to the covered group.
Other Names:
  • Temperature
  • Pediatric
  • Urology
  • Anesthesia

Detailed Description:

Some anesthesiologists cover the pediatric patient with a blanket during the induction of general anesthesia, while others do not. Complaints have been raised by pediatric surgeons that if a pediatric patient is not covered during induction of general anesthesia, the child's core body temperature will be lower than normal following surgery and in the recovery room.

Children are at risk of significant heat loss in the operating room due to multiple factors, such as, exposure to cold temperatures, decrease in metabolism following induction of general anesthesia, increased surface-area-to-volume ratio, and through considerable respiratory heat loss.1

A decrease in temperature of 0.5ºC to 1.5ºC can occur during induction of general anesthesia in pediatric patients2. The use of heating blankets and warmers may increase temperature or result in a constant temperature on pediatric patients intra-operatively3. We want to investigate the differences in temperature between the two approaches, covering and not covering pediatric patients, during induction of general anesthesia of a urologic procedure with a caudal block and the difference in temperature post-operatively. We hypothesize that the core temperatures of:

  1. the covered and warmed group during induction of general anesthesia will be greater by 0.5ºC than the uncovered group during induction of general anesthesia.
  2. both groups, covered and uncovered, will be equal during surgery and post-operatively. In other words, due to the active warming procedures during surgery and post-operatively in the PICU, core temperatures of the uncovered group will catch up to the covered group.
  Eligibility

Ages Eligible for Study:   6 Months to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Children in an academic center

Criteria

Inclusion Criteria:

  • The ages of the subjects ranging from 6 months to 3 years undergoing surgery for circumcision or hernia repair with caudal block.

Exclusion Criteria:

  • ASA physical status classification greater than 2, unsigned or unattainable written informed consent form, induction of general anesthesia time of greater than 45 minutes, fever, or temperature regulation inability.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710320

Locations
United States, Oklahoma
The University of Oklahoma Health Sciences Center Deparment of Anesthesiology
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Mohanad Shukry, MD The University of Oklahoma Health Sciences Center
  More Information

Publications:

Responsible Party: Mohanad Shukry/MD, University of Oklahoma Health Siences Center/Pediatric Anesthesiology
ClinicalTrials.gov Identifier: NCT00710320     History of Changes
Other Study ID Numbers: IRB No 14004
Study First Received: July 3, 2008
Last Updated: February 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Children core temperature,
Pediatric surgery,
Anesthesia induction

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013