Effect of Sevoflurane on Sweat Threshold in Children of Different Ages

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Endotracheal Intubation With Sevoflurane in Surgical Pediatric Patients

NCT02429323

Anesthesia; Reaction

COMPLETED NA

The EEG Study Under Sevoflurane Anesthesia in Children

NCT06580028

Electroencephalography Sevoflurane Child Neglect

RECRUITING

Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure

NCT04188782

Anesthesia Tolerance

COMPLETED

Effect of Head Position on MACEI of Sevoflurane in Children With Obstructive Airway

NCT03522402

Sevoflurane Endotracheal Intubation

UNKNOWN NA

The Effect of Sevoflurane on Haemodynamics

NCT06707077

Sevoflurane Cardiac Output Venous Return +1 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Child, Only Temperature Regulation; Disorder Low Body Temperatures Sevoflurane

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

temperature monitoring

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.

Intervention Type DEVICE

Sevoflurane

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age: 0-12 years old;
2. American Society of Anesthesiologists physical status I or II;
3. Weight within the normal range and body-mass index (BMI) for age between the 25th and 85th percentiles;
4. scheduled elective lower-body surgery under general anesthesia, expected to last at least 1 hour.

Exclusion Criteria

1. The guardian of the child refused to participate in the study;
2. Operations involving extensive incisions, such as massive debridement or other operations requiring removal of large amounts of tissue;
3. Contraindications to esophageal temperature probe insertion (e.g., esophageal varices, congenital anomalies);
4. Thyroid dysfunction or autonomic dysfunction;
5. Premature infants (≤1 year old).

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes