Temperature Changes During Induction of General Anesthesia in Pediatric Patients

Hypothermia Clinical Trial

Official title:

Temperature Changes During Induction of General Anesthesia in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710320
• Other study ID #: IRB No 14004
• Status: Completed
• Phase: N/A
• First received: July 3, 2008
• Last updated: February 3, 2010
• Start date: July 2008
• Est. completion date: March 2009

Study information

• Verified date: February 2010
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 3 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypothermia

Intervention

Procedure:
• Covered and uncovered anesthesia induction
We hypothesize that the core temperatures of: the covered group during induction of general anesthesia will be greater by 0.5ºC than the uncovered group during induction of general anesthesia. 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.

Locations

Country	Name	City	State
United States	The University of Oklahoma Health Sciences Center Deparment of Anesthesiology	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bissonnette B. Temperature monitoring in pediatric anesthesia. Int Anesthesiol Clin. 1992 Summer;30(3):63-76. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Covered group during induction of general anesthesia will be greater by 0.5ºC than the uncovered group during induction of general anesthesia.		1.5 years	Yes
Secondary	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.		1.5 years	Yes