- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00710320
Temperature Changes During Induction of General Anesthesia in Pediatric Patients
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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:
- 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.
- 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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- The University of Oklahoma Health Sciences Center Deparment of Anesthesiology
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Cover and Uncover
Procedure/Surgery
|
We hypothesize that the core temperatures of:
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Covered group during induction of general anesthesia will be greater by 0.5ºC than the uncovered group during induction of general anesthesia.
Tidsram: 1.5 years
|
1.5 years
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
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.
Tidsram: 1.5 years
|
1.5 years
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Mohanad Shukry, MD, The University of Oklahoma Health Sciences Center
Publikationer och användbara länkar
Allmänna publikationer
- Bissonnette B. Temperature monitoring in pediatric anesthesia. Int Anesthesiol Clin. 1992 Summer;30(3):63-76.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB No 14004
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Kliniska prövningar på Covered and uncovered anesthesia induction
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