Depth of anaesthesia related to the changes in patient body temperature during surgery requiring deep hypothermia

Not Applicable

• Conditions: Prevention of both awake anaesthesia and anaesthetic ovedose in patients undergoing surgery in deep hypothermia; Surgery

• Registration Number: ISRCTN23417303
• Lead Sponsor: General University Hospital in Prague

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-01-10
• Last Update Posted: 19 February 2024
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients with chronic thromboembolic pulmonary hypertension (CTEPH) undergoing elective pulmonary endarterectomy (PEA)
2. Aged 18 years old and over.
3. No history of chronic renal or hepatic failure
4. No history of opioid withdrawal
5. Signed informed consent

Exclusion Criteria

1. Refusal to sign the informed consent
2. History of renal or hepatic failure
3. Age off the limit

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following primary outcome measures will be assessed immediately before induction in general anaesthesia (norepinephrine only), 5 minutes after induction in general anaesthesia, and 5 minutes after the start of extracorporeal circulation, in 35, 30, 25, and 20 degrees of C respectively, in target temperature, between 2 periods of circulatory arrest, during rewarming in 20, 25, 30 and 35 degrees of C:<br>1. Plasma concentration of propofol, sufentanil and norepinephrine measured using sensitive UHPLC-MS/MS (ultra-high performance liquid chromatography-tandem mass spectrometry) with isotopically labelled internal standards on the Shimadzu UHPLC Nexera X3 coupled with a Triple Quad 8045 tandem mass spectrometer with methodology validated following the European Medicines Agency (EMA) Guideline on bioanalytical method validation<br>2. Depth of anaesthesia level measured using the Masimo Next Generation SedLine monitor<br>

Secondary Outcome Measures

Name	Time	Method
1. Total doses of vasopressors, anaesthetics and muscle relaxants measured using data from the medical files after the end of the surgical procedure<br>2. Prevalence of awareness during anaesthesia measured using the modified Brice questionnaire at the ICU after the patient's extubation on the second or third postoperative day (depending on the patient's condition to respond)<br>