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Effect of intranasal insulin pretreatment on sleep quality and postoperative delirium in patients undergoing rheumatic heart valve replacement surgeryt

Effect of intranasal insulin pretreatment on sleep quality and postoperative delirium in patients undergoing rheumatic heart valve replacement surgeryt

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048515
Enrollment
Unknown
Registered
2021-07-09
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

Postoperative delirium

Interventions

Sponsors

The General Hospital of Western Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years; 2. Undergoing heart valve replacement surgery under CPB; 3. ASA grade ii ~ iii; 4. Operation time 2-6 hours; 5. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Preoperative rheumatic activities; 2. Heparin resistance; 3. Abnormal coagulation function; 4. Severe liver and kidney damage; 5. CPB is difficult to stop; 6. Preoperative left ventricular ejection fraction less than 30%; 7. Previous hypertension and diabetes; 8. Have a history of insulin allergy; 9. Have a history of alcoholism; 10. Preoperative inability to communicate (coma, profound dementia or language impairment, severe visual and hearing impairment); 11. Preoperative mini-mental state examination (MMSE) score is too low [illiterate < 17 points, primary school level < 20 points, secondary school level (including secondary school) < 24 points]; 12. History of neurological or psychiatric disorders.

Design outcomes

Primary

MeasureTime frame
Plasma cortisol;Incidence of delirium;Sleep latency;Rapid eye movement sleep Incubation period;Total sleep time;Sleep efficiency (%);Number of awakenings (times);

Secondary

MeasureTime frame
Plasma insulin concentration;age;gender;body mass index;Educational level;Operation time;extracorporeal circulation time;preoperative hemoglobin concentration;intraoperative blood transfusion;intraoperative blood loss;

Countries

China

Contacts

Public ContactGong Gu

The General Hospital of Western Theater Command

gonggu68@163.com+86 13980525688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026