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Effect of hypothermia on the depth of anesthesia in patients undergoing cardiac surgery under cardiopulmonary bypass

Effect of hypothermia on the depth of anesthesia in patients undergoing cardiac surgery under cardiopulmonary bypass

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000030151
Enrollment
Unknown
Registered
2020-02-24
Start date
2018-12-05
Completion date
Unknown
Last updated
2020-02-25

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

Conditions

cardiopulmonary bypass in cardiac surgery

Interventions

1:The skin of the patients’ forehead will be carefully cleaned with 70% isopropyl alcohol. After drying, electrodes for RE will be placed as follows in combination with the manufacturer’s recommendati
2:The skin of the patients’ forehead will be carefully cleaned with 70% isopropyl alcohol. After drying, electrodes for SE will be placed as follows in combination with the manufacturer’s recommendati
3:The skin of the patients’ forehead will be carefully cleaned with 70% isopropyl alcohol. After drying, electrodes for Bis will be placed as follows in combination with the manufacturer’s recommendat

Sponsors

The First Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Participants undergoing elective cardiac surgery with hypothermic CPB; 2. Acknowledgement and acceptance of written informed consent; 3. Aged between 16 and 60 years and an ASA score of II-III; 4. Body weight > 50 kg and body mass index between 18 and 24 kg/m2; 5. CPB with an estimated duration of at least two hours.

Exclusion criteria

Exclusion criteria: 1. Pre-existing psychiatric or neurologic disorders; 2. History of major trauma to the head; 3. Long-term drug abuse; 4. Medication affecting the central nervous system; 5. Congenital or acquired scalp or skull abnormalities; 6. Patients participating in other clinical trials; 7. Pre-operative platelet counting < 100 x 109, platelet insufficiency, or coagulopathy; 8. Hepatic or renal dysfunction; 9. Hypoproteinemia (total protein < 60 g); 10. Allergic reaction to anesthetic drugs; 11. Women who are pregnant or lactating.

Design outcomes

Primary

MeasureTime frame
RE;SE;the Bis;the nasopharyngeal temperature;

Secondary

MeasureTime frame
patient age; gender; height; weight; major pre-operative diagnosis; surgical name; the presence of hypertension or diabetes; a history of pre-operative myocardial infarction; cardiac ejection fraction; duration of CPB; and aortic clipping.;patient age; gender; height; weight; major pre-operative diagnosis; surgical name; the presence of hypertension or diabetes; a history of pre-operative myocardial infarction; cardiac ejection fraction; duration of CPB; and aortic clipping.;

Countries

China

Contacts

Public ContactTian Ayong

The first hospital of China Medical University

tay0626@126.com+86 13940182455

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026