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临床试验/NCT07035782
NCT07035782尚未招募不适用

Effect of Sevoflurane on Sweat Threshold in Children of Different Ages

Second Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
The threshold esophageal temperature

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
— 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

研究组 & 干预措施

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

干预措施: Sevoflurane (Drug)

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

干预措施: temperature monitoring (Device)

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

干预措施: Sevoflurane (Drug)

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

干预措施: temperature monitoring (Device)

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

干预措施: temperature monitoring (Device)

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

干预措施: Sevoflurane (Drug)

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

干预措施: temperature monitoring (Device)

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

干预措施: Sevoflurane (Drug)

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

干预措施: temperature monitoring (Device)

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

干预措施: Sevoflurane (Drug)

结局指标

主要结局

The threshold esophageal temperature

时间窗: During the operation

The threshold esophageal temperature at which forehead sweating is first observed (any sustained increase in cutaneous water loss).

次要结局

  • The gain of sweating(During the operation)
  • Maximum sweating rate(During the operation)

研究者

发起方
Second Affiliated Hospital of Wenzhou Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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