Inadvertent Hypothermia or Hyperthermia in Pediatric Radiotherapy Practices Under Anesthesia

Childhood Cancer Clinical Trial

Official title:

An Observational Cohort Study of Inadvertent Hypothermia or Hyperthermia in Pediatric Radiotherapy Practices Under Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05478850
• Other study ID #: E1-22-2700
• Status: Completed
• Start date: August 1, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: July 2022
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In prospective, observational cohort study, changes in body temperature will be investigated before the procedure and during recovery in Radiotherapy patients aged 0-18 years who need sedation due to childhood malignancies.

The aims of this study were to measure the incidence and magnitude of changes in body temperature in children undergoing sedation or general anesthesia for Radiotherapy, and to determine their effects on the recovery process.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• patients undergoing radiotherapy under anesthesia

Exclusion Criteria:

• family refusal to participate,

• chronic nausea and vomiting complaints,

• active infection,

• apnea history,

• cardiac disease, kidney and liver failure,

• anomalies that may cause difficult airway,

• metabolic diseases,

• neurological or muscular diseases.

Related Conditions & MeSH terms

• Childhood Cancer
• Fever
• Hyperthermia
• Hypothermia
• Hypothermia; Anesthesia
• Malignant Hyperthermia
• Radiotherapy Side Effect

Intervention

Procedure:
• radiotherapy under anesthesia
Body temperature change will be investigated before the procedure and during recovery in Radiotherapy patients who need anesthesia due to childhood malignancies.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body temperature change among 2 time period	non-contact body temperature measured on forehead	time from before radiotherapy to the end of radiotherapy
Primary	recovery time from anesthesia	Time from the end of the procedure until the Modified Steward score = 8 in the patient recovery room	the time from end of radiotherapy to discharging