跳至主要内容
临床试验/NCT06303518
NCT06303518招募中不适用

Effects of End Tidal Carbon Dioxide Concentration on Depth of Anesthesia in Children Undergoing Total Intravenous Anesthesia

University of British Columbia2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
To determine the effect of end-tidal carbon dioxide concentration (EtCO2) on the depth of anesthesia in children, as measured by BIS.

研究概览

简要总结

Carbon Dioxide (CO2) is a by-product of metabolism and is removed from the body when we breathe out. High levels of CO2 can affect the nervous system and cause us to be sleepy or sedated. Research suggests that high levels of CO2 may benefit patients who are asleep under anesthesia, such as by reducing infection rates, nausea, or recovery from anesthesia . CO2 may also reduce pain signals or the medication required to keep patients asleep during anesthesia; this has not been researched in children.

During general anesthesia, anesthesiologists keep patients asleep with anesthetic gases or by giving medications into a vein. These drugs can depress breathing; therefore, an anesthesiologist will control breathing (ventilation) with an artificial airway such as an endotracheal tube. Changes in ventilation can alter the amount of CO2 removed from the body. The anesthesiologist may also monitor a patient's level of consciousness using a 'Depth of Anesthesia Monitor' such as the Bispectral Index (BIS), which analyzes a patient's brain activity and generates a number to tell the anesthesiologist how asleep they are.

The investigator's study will test if different levels of CO2 during intravenous anesthesia are linked with different levels of sedation or sleepiness in children, as measured by BIS. If so, this could reduce the amount of anesthetic medication the child receives. Other benefits may be decreased medication costs, fewer side effects, and a positive environmental impact by using less disposable anesthesia equipment.

详细描述

Purpose: Carbon dioxide (CO2) is a major end-product of metabolism and can have marked effects on central nervous system function. It can also be easily manipulated during general anesthesia via controlled ventilation. High levels of carbon dioxide (hypercapnia) are associated with sedation and have been shown to produce selective suppression of thermal and ischaemic pain in animals and humans. This effect was attenuated by dexamethasone and naloxone, indicating that stress pathways and endogenous opioids may be implicated. Hypercapnia during anesthesia may have additional benefits, including reduced levels of wound infection due to improved tissue oxygenation reduced incidence of postoperative nausea and vomiting and reduced recovery time from volatile anesthetic.

It is a known phenomenon for high levels of CO2 to be associated with reduced levels of consciousness in humans, known as CO2 narcosis. A 1927 paper described narcosis of animals when breathing 30-40% CO2 in oxygen, with prompt recovery upon removal. The authors described a 'sharp sour taste' and associated hypertension when the same solution was administered to humans. However, few studies investigate the impact of carbon dioxide on anesthetic requirements. An animal study from 1967 demonstrated that very high levels of CO2 (>95 mmHg) offset halothane requirements in dogs. Most recently, increased carbon dioxide levels during surgery (40 - 45 mmHg) were shown to reduce the Minimal Alveolar Concentration to Blunt Adrenergic Response (skin incision; MAC-BAR) of sevoflurane in adult patients undergoing gastric carcinoma resection.

Total intravenous anesthesia (TIVA), an alternative to inhalational anesthesia, is a commonly used anesthetic technique in the investigator's institution. This is due to its many benefits, including reduced emergence delirium, reduced environmental impact and reduced post-operative nausea and vomiting. Administration can be guided by depth of anesthesia monitoring such as the Bispectral Index (BIS), which measures the patient's level of consciousness derived from electroencephalogram readings. BIS has been shown to help guide propofol dosing in children regardless of whether the TIVA technique was target controlled or a manual infusion regimen, and to correlate well with both modelled and measured propofol levels in children.

The investigator's study aims to determine whether differing levels of CO2 affect the anesthetic depth in anesthetized children, as measured by BIS.

Hypothesis: Hypercarbia is associated with a reduction in BIS readings, in anesthetized children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Care Provider)

盲法说明

The anesthesiologist will be blinded to the BIS reading and will continue to provide anesthesia according to the protocol. The BIS numerical value in the OR will be covered, but the waveform will be visible to assess signal quality. The anesthesiologist providing care to the patient will not be involved in data collection or analysis

入排标准

年龄范围
3 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 3 - 11 years undergoing non- or minimally-stimulating elective procedures, defined as anesthesia without skin incision or painful manipulation (e.g., non-invasive imaging, auditory brainstem response testing), middle ear surgery, surgery with effective local or regional anesthesia before surgical incision (e.g dental procedures with local anesthetic infiltration, urology with regional block).
  • American Society of Anesthesiologists (ASA) physical status I and II
  • TIVA technique appropriate throughout induction and maintenance of anesthesia
  • Controlled ventilation via endotracheal tube
  • Anticipated surgical time ≥ 90 minutes: to allow time for anesthetic induction and subsequent testing and washout periods at all three EtCO2 levels.

排除标准

  • Need for inhalational induction of anesthesia
  • Sedative premedication
  • Use of ketamine intraoperatively
  • Unable to place BIS electrodes due to surgical site or other contraindications (e.g., MRI)
  • Allergy to study drugs (propofol, remifentanil, lidocaine)
  • Depression of conscious level for any reason
  • BMI <5th or >95th centile for age
  • History of obstructive or central sleep apnea
  • Known or suspected raised intracranial pressure
  • Recent or historical traumatic brain injury

研究组 & 干预措施

Low normal ETCO2, High normal ETCO2, Normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: High normal ETCO2: ETCO2 50 mmHg (+/- 3mmHg) (Other)

Low normal ETCO2, High normal ETCO2, Normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: Normal ETCO2: ETCO2 40 mmHg (+/- 3mmHg) (Other)

High normal ETCO2, Normal ETCO2, Low normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: High normal ETCO2: ETCO2 50 mmHg (+/- 3mmHg) (Other)

High normal ETCO2, Normal ETCO2, Low normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: Normal ETCO2: ETCO2 40 mmHg (+/- 3mmHg) (Other)

Low normal ETCO2, High normal ETCO2, Normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: Low Normal ETCO2: ETCO2 30 mmHg (+/- 3mmHg) (Other)

High normal ETCO2, Normal ETCO2, Low normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: Low Normal ETCO2: ETCO2 30 mmHg (+/- 3mmHg) (Other)

High normal ETCO2, Low normal ETCO2, Normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: High normal ETCO2: ETCO2 50 mmHg (+/- 3mmHg) (Other)

High normal ETCO2, Low normal ETCO2, Normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: Normal ETCO2: ETCO2 40 mmHg (+/- 3mmHg) (Other)

High normal ETCO2, Low normal ETCO2, Normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: Low Normal ETCO2: ETCO2 30 mmHg (+/- 3mmHg) (Other)

Low normal ETCO2, Normal ETCO2, High normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: High normal ETCO2: ETCO2 50 mmHg (+/- 3mmHg) (Other)

Low normal ETCO2, Normal ETCO2, High normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: Normal ETCO2: ETCO2 40 mmHg (+/- 3mmHg) (Other)

Low normal ETCO2, Normal ETCO2, High normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: Low Normal ETCO2: ETCO2 30 mmHg (+/- 3mmHg) (Other)

Normal ETCO2, Low normal ETCO2, High normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: High normal ETCO2: ETCO2 50 mmHg (+/- 3mmHg) (Other)

Normal ETCO2, Low normal ETCO2, High normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: Normal ETCO2: ETCO2 40 mmHg (+/- 3mmHg) (Other)

Normal ETCO2, Low normal ETCO2, High normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: Low Normal ETCO2: ETCO2 30 mmHg (+/- 3mmHg) (Other)

Normal ETCO2, High normal ETCO2, Low normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: High normal ETCO2: ETCO2 50 mmHg (+/- 3mmHg) (Other)

Normal ETCO2, High normal ETCO2, Low normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: Normal ETCO2: ETCO2 40 mmHg (+/- 3mmHg) (Other)

Normal ETCO2, High normal ETCO2, Low normal ETCO2

Experimental

All patients will receive same interventions, in a randomised order.

干预措施: Low Normal ETCO2: ETCO2 30 mmHg (+/- 3mmHg) (Other)

结局指标

主要结局

To determine the effect of end-tidal carbon dioxide concentration (EtCO2) on the depth of anesthesia in children, as measured by BIS.

时间窗: Continually assessed throughout the general anesthetic, approximately 1.5-2 hours

The investigator's study aims to determine whether differing levels of CO2 affect the anesthetic depth in anesthetized children, as measured by BIS. The investigators will determine a significant change in BIS to be at least a 5 point difference. Patients will act 'as their own controls', and be tested across three ETCO2 levels in a randomized order.

次要结局

  • Patient movement as detected clinically by the surgical or anesthetic team.(Continually assessed throughout the general anesthetic, approximately 1.5-2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Chin

Clinical Associate Professor

University of British Columbia

研究点 (2)

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