Effect of Sevoflurane on Sweat Threshold in Children of Different Ages
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 12
SponsorSecond Affiliated Hospital of Wenzhou Medical University
About this trial
Hypothermia is a common complication in pediatric anesthesia. Hypothermia will prolong the recovery time of anesthesia, and may also lead to increased oxygen consumption, prolonged blood coagulation time, and affect the metabolism of anesthetic drugs and postoperative immune function. Sevoflurane is the most commonly used inhaled anesthetic in children. This study explored the effect of sevoflurane on the sweat threshold of pediatric patients and analyzed the characteristics of body temperature regulation in children of different ages under anesthesia, which will help to understand the mechanism of body temperature regulation in children under anesthesia, and also provide a scientific basis for clinical anesthesia temperature management.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age: 0-12 years old;
American Society of Anesthesiologists physical status I or II;
Weight within the normal range and body-mass index (BMI) for age between the 25th and 85th percentiles;
scheduled elective lower-body surgery under general anesthesia, expected to last at least 1 hour.
Disqualifiers
The guardian of the child refused to participate in the study;
Operations involving extensive incisions, such as massive debridement or other operations requiring removal of large amounts of tissue;
Contraindications to esophageal temperature probe insertion (e.g., esophageal varices, congenital anomalies);
Thyroid dysfunction or autonomic dysfunction;
Trial design
Design model
Parallel
Treatments tested in this trial
temperature monitoring
DeviceCore temperature will be measured in the distal esophagus. The esophageal probe will be inserted after intubation to the depth from the upper incisors recommended by Bloch et al,1 specifically one-quarter of the patient's height plus 4.5 cm.
Sevoflurane
DrugAnesthesia induction will be standardized for all participants., the children will undergo inhalational induction using 8% sevoflurane with a fresh gas flow of 5 L/min in 100% oxygen. Once children loses consciousness, the sevoflurane concentration will be reduced to 3%-5% and then maintained as close as possible to 1.2 MAC, age-adjusted
Treatment groups
100 Participants
are divided into 5 treatment groupsGroup A: Birth to 28 daysExperimental treatment 2 interventions
Group B: one month to 1 yearExperimental treatment 2 interventions
Group C: 1 to 3 yearsExperimental treatment 2 interventions
Group D: 3 to 6 yearsExperimental treatment 2 interventions
Group E: 6 to 12 yearsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The threshold esophageal temperature
The threshold esophageal temperature at which forehead sweating is first observed (any sustained increase in cutaneous water loss).
Time frame
During the operationSecondary outcomes
1
The gain of sweating
the slope of the core temperature versus quantitative sweating rate from onset of sweating until the maximum is reached
Time frame
During the operation2
Maximum sweating rate
as indicated by no further increase in sweat rate despite further increase in core temperature
Time frame
During the operationSponsors and contacts
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Source ClinicalTrials.gov
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