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

Monitoring of the depth of anaesthesia in patients undergoing surgery on extracorporeal circulation with circulatory arrest in deep hypothermia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN23417303

Enrollment

Registered

2024-01-10

Start date

2024-01-16

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of both awake anaesthesia and anaesthetic overdose in patients undergoing surgery in deep hypothermia Surgery

Interventions

This is a single centre minimally invasive study planned for 2 years that will include 30 patients undergoing surgery for extracorporeal circulation with deep hypothermia and circulatory arrest. The b

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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: 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 2. Depth of anaesthesia level measured using the Masimo Next Generation SedLine monitor	—

Measure

Time frame

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: 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 2. Depth of anaesthesia level measured using the Masimo Next Generation SedLine monitor

—

Secondary

Measure	Time frame
1. Total doses of vasopressors, anaesthetics and muscle relaxants measured using data from the medical files after the end of the surgical procedure 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)	—

Countries

Czech Republic

Contacts

Public ContactJan Kunstyr

jan.kunstyr@vfn.cz+420724828725

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026