Clinical trial NCT00710320: Temperature Changes During Induction of General Anesthesia in Pediatric Patients
Official title: Temperature Changes During Induction of General Anesthesia in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia
Keywords: Children core temperature,
Pediatric surgery,
Anesthesia induction
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2008-07-04
Enrollment: 44
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children in an academic center

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

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 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.

Primary outcomes:
measure: Covered group during induction of general anesthesia will be greater by 0.5ºC than the uncovered group during induction of general anesthesia.
timeFrame: 1.5 years
Secondary outcomes:
measure: 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.
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center Deparment of Anesthesiology
state: Oklahoma
Study officials:
affiliation: The University of Oklahoma Health Sciences Center
name: Mohanad Shukry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bissonnette B. Temperature monitoring in pediatric anesthesia. Int Anesthesiol Clin. 1992 Summer;30(3):63-76.
citation: Hynson JM, Sessler DI, Moayeri A, McGuire J, Schroeder M. The effects of preinduction warming on temperature and blood pressure during propofol/nitrous oxide anesthesia. Anesthesiology. 1993 Aug;79(2):219-28, discussion 21A-22A. doi: 10.1097/00000542-199308000-00005.