Effect of Sevoflurane on Sweat Threshold in Children of Different Ages

NCT07035782 | Not Yet Recruiting DMC

• 1 other identifier: SAHoWMU-CR2025-03-214
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Child, Only; Temperature Regulation; Disorder; Low Body Temperatures; Sevoflurane

Keywords

Pediatric Anesthesia; Low Body Temperatures; Sevoflurane

Outcome Measures

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).

  During the operation

Secondary Outcomes (2)

• The gain of sweating

  During the operation

• Maximum sweating rate

  During the operation

Study Arms (5)

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

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

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

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

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

Device: temperature monitoring; Drug: Sevoflurane

Interventions

temperature monitoring DEVICE

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.

1 to 3 years; 3 to 6 years; 6 to 12 years; Birth to 28 days; one month to 1 year

Sevoflurane DRUG

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

1 to 3 years; 3 to 6 years; 6 to 12 years; Birth to 28 days; one month to 1 year

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University Wenzhou

Wenzhou, Zhejiang, China

Location

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Central Study Contacts

Huacheng Liu

CONTACT

13957770577; huachengliu@163.com

Yuhang Cai

CONTACT

18815091585; 838097626@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: June 25, 2025
• Study Start: June 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

CN (1)