Child, OnlyNCT07035782
Effect of Sevoflurane on Sweat Threshold in Children of Different Ages
A study testing temperature monitoring and Sevoflurane in people with Child, Only and Temperature Regulation; Disorder, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only, Temperature Regulation; Disorder, Low Body Temperatures
- What is being tested?
- temperature monitoring and Sevoflurane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
- Premature infants (≤1 year old).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University Wenzhou
Wenzhou, Zhejiang
About this study
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.
Read the detailed description
Standardized anesthesia induction was used for all participants. The first step was mask oxygen inhalation under 5 L/min pure oxygen, and 8% sevoflurane was inhaled for induction. Once the child lost consciousness, the concentration of sevoflurane was reduced to 3%-5% and maintained at 1.2 MAC as much as possible. Tracheal intubation was then assisted with cisatracurium 0.2 mg/kg. Mechanical ventilation was maintained during the operation, and the end-tidal carbon dioxide level was monitored and maintained at about 35 mmHg. Caudal anesthesia with 0.25% ropivacaine was used to provide surgical site analgesia. TOF was performed throughout the procedure to monitor the depth of neuromuscular block. Core temperature was measured in the distal esophagus. The esophageal probe was inserted after intubation to a depth of one quarter of the patient's height plus 4.5 cm. Changes in surface humidity were monitored using an OM-62 humidity sensor, which was placed above the nipple line in the upper chest and suspended in the ostomy bag. The ostomy bag will be custom-cut as needed to ensure optimal fit and precise airflow control. Infants and young children (<6 years) will use a 4-cm diameter opening, while older children (6 to 12 years) will use a 6-cm diameter opening. To ensure smooth airflow in the stoma bag, a low flow meter will be used to accurately adjust the airflow rate to 0.5L/min. Skin water loss (in g/m²/h) will be calculated from airflow rate, temperature, and relative humidity, and sweating on the child's forehead will be observed and recorded every 3 minutes. The skin surface was wrapped with a plastic film to limit evaporation. An air mattress was used to cover the body up to the nipple line. Two disposable covers were placed on each chest and leg and connected to an inflatable heating device, respectively. The inflatable heating device was set to 43 ° C until the esophageal temperature reached 38 ° C. Core temperature as well as temperature and humidity in the ostomy bag were collected every minute. The Hotline system was used to warm the intravenous infusion. Once the patient's core temperature reached 38 ° C or the procedure was over, active warming was stopped. Heart rate and pulse oxygen saturation were continuously monitored, and blood pressure was measured every 3 minutes. Simulated data from the heart rate monitor, sweat sensor, respiratory gas monitor, and pulse oximeter were recorded at 3-min intervals using the data acquisition system described above. The end-expiratory anesthetic concentration during the whole procedure was also recorded.
- Being tested
- temperature monitoring, Sevoflurane
- Keywords
- Pediatric Anesthesia, Low Body Temperatures, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temperature monitoringDevice
Core 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.
SevofluraneDrug
Anesthesia 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
| Study group | Role | What they receive |
|---|---|---|
| Birth to 28 days | Experimental | Children will undergo standard induction of sevoflurane anesthesia as described above, with body temperature monitored and sweating assessed using quantitative and qualitative methods Receives: Device: temperature monitoring; Drug: Sevoflurane |
| one month to 1 year | Experimental | Children will undergo standard induction of sevoflurane anesthesia as described above, with body temperature monitored and sweating assessed using quantitative and qualitative methods Receives: Device: temperature monitoring; Drug: Sevoflurane |
| 1 to 3 years | Experimental | Children will undergo standard induction of sevoflurane anesthesia as described above, with body temperature monitored and sweating assessed using quantitative and qualitative methods Receives: Device: temperature monitoring; Drug: Sevoflurane |
| 3 to 6 years | Experimental | Children will undergo standard induction of sevoflurane anesthesia as described above, with body temperature monitored and sweating assessed using quantitative and qualitative methods Receives: Device: temperature monitoring; Drug: Sevoflurane |
| 6 to 12 years | Experimental | Children will undergo standard induction of sevoflurane anesthesia as described above, with body temperature monitored and sweating assessed using quantitative and qualitative methods Receives: Device: temperature monitoring; Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
The threshold esophageal temperature
The threshold esophageal temperature at which forehead sweating is first observed (any sustained increase in cutaneous water loss).
Measured: During the operation
Secondary outcomes (2)
The gain of sweating
the slope of the core temperature versus quantitative sweating rate from onset of sweating until the maximum is reached
Measured: During the operation
Maximum sweating rate
as indicated by no further increase in sweat rate despite further increase in core temperature
Measured: During the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035782
- Sponsor's protocol ID
- SAHoWMU-CR2025-03-214
- Status last verified
- Jun 2025
- First submitted
- 13 Apr 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sevoflurane on Sweat Threshold in Children of Different Ages
- ClinicalTrials.gov ID
- NCT07035782
- Acronym / sponsor ID
- SAHoWMU-CR2025-03-214
- Keywords
- Pediatric Anesthesia, Low Body Temperatures, Sevoflurane
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Standardized anesthesia induction was used for all participants. The first step was mask oxygen inhalation under 5 L/min pure oxygen, and 8% sevoflurane was inhaled for induction. Once the child lost consciousness, the concentration of sevoflurane was reduced to 3%-5% and maintained at 1.2 MAC as much as possible. Tracheal intubation was then assisted with cisatracurium 0.2 mg/kg. Mechanical ventilation was maintained during the operation, and the end-tidal carbon dioxide level was monitored and maintained at about 35 mmHg. Caudal anesthesia with 0.25% ropivacaine was used to provide surgical site analgesia. TOF was performed throughout the procedure to monitor the depth of neuromuscular block. Core temperature was measured in the distal esophagus. The esophageal probe was inserted after intubation to a depth of one quarter of the patient's height plus 4.5 cm. Changes in surface humidity were monitored using an OM-62 humidity sensor, which was placed above the nipple line in the upper chest and suspended in the ostomy bag. The ostomy bag will be custom-cut as needed to ensure optimal fit and precise airflow control. Infants and young children (<6 years) will use a 4-cm diameter opening, while older children (6 to 12 years) will use a 6-cm diameter opening. To ensure smooth airflow in the stoma bag, a low flow meter will be used to accurately adjust the airflow rate to 0.5L/min. Skin water loss (in g/m²/h) will be calculated from airflow rate, temperature, and relative humidity, and sweating on the child's forehead will be observed and recorded every 3 minutes. The skin surface was wrapped with a plastic film to limit evaporation. An air mattress was used to cover the body up to the nipple line. Two disposable covers were placed on each chest and leg and connected to an inflatable heating device, respectively. The inflatable heating device was set to 43 ° C until the esophageal temperature reached 38 ° C. Core temperature as well as temperature and humidity in the ostomy bag were collected every minute. The Hotline system was used to warm the intravenous infusion. Once the patient's core temperature reached 38 ° C or the procedure was over, active warming was stopped. Heart rate and pulse oxygen saturation were continuously monitored, and blood pressure was measured every 3 minutes. Simulated data from the heart rate monitor, sweat sensor, respiratory gas monitor, and pulse oximeter were recorded at 3-min intervals using the data acquisition system described above. The end-expiratory anesthetic concentration during the whole procedure was also recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Birth to 28 days | Experimental | Device: temperature monitoring, Drug: SevofluraneChildren will undergo standard induction of sevoflurane anesthesia as described above, with body temperature monitored and sweating assessed using quantitative and qualitative methods |
| one month to 1 year | Experimental | Device: temperature monitoring, Drug: SevofluraneChildren will undergo standard induction of sevoflurane anesthesia as described above, with body temperature monitored and sweating assessed using quantitative and qualitative methods |
| 1 to 3 years | Experimental | Device: temperature monitoring, Drug: SevofluraneChildren will undergo standard induction of sevoflurane anesthesia as described above, with body temperature monitored and sweating assessed using quantitative and qualitative methods |
| 3 to 6 years | Experimental | Device: temperature monitoring, Drug: SevofluraneChildren will undergo standard induction of sevoflurane anesthesia as described above, with body temperature monitored and sweating assessed using quantitative and qualitative methods |
| 6 to 12 years | Experimental | Device: temperature monitoring, Drug: SevofluraneChildren will undergo standard induction of sevoflurane anesthesia as described above, with body temperature monitored and sweating assessed using quantitative and qualitative methods |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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;
- Premature infants (≤1 year old).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temperature monitoringCore 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. | Device | 1 to 3 years, 3 to 6 years, 6 to 12 years, Birth to 28 days, one month to 1 year |
| SevofluraneAnesthesia 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 | Drug | 1 to 3 years, 3 to 6 years, 6 to 12 years, Birth to 28 days, one month to 1 year |
Primary outcome
The threshold esophageal temperature
Time frame: During the operation
The threshold esophageal temperature at which forehead sweating is first observed (any sustained increase in cutaneous water loss).
2 secondary outcomes
The gain of sweating
Time frame: During the operation
Maximum sweating rate
Time frame: During the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing temperature monitoring and Sevoflurane in people with Child, Only and Temperature Regulation; Disorder, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huacheng Liu (13957770577, huachengliu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The threshold esophageal temperature (time frame: During the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.