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A prospective, observational cohort study of inadvertent perioperative hypothermia and postoperative delirium

A prospective, observational cohort study of inadvertent perioperative hypothermia and postoperative delirium

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100052826
Enrollment
Unknown
Registered
2021-11-06
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-08-23

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

Conditions

Postoperative delirium

Interventions

Control group:No
Inadvertent perioperative hypothermia group:No

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years, both male and female; 2. Patients undergoing elective surgery under general anesthesia or general anesthesia combined with other anesthesia; 3. The operation is expected to last more than 40 minutes.

Exclusion criteria

Exclusion criteria: 1. Central diseases including cerebrovascular diseases, brain trauma and brain surgery, epilepsy, acute hydrocephalus, etc.; 2. Dysthermoregulation includes malignant hyperthermia syndrome (MHS), neuroleptic malignant syndrome, and patients with clearly confirmed hypothyroidism or hyperthyroidism who currently have abnormal thyroid function; 3. Infectious fever; 4. The body temperature was higher than 38.5 degrees three days before surgery due to other reasons; 5. Operations requiring active cooling, such as cardiopulmonary bypass; 6. All diseases or operations that affect the use of thermometers and heating blankets; 7. Preoperative MMSE score < 27, prior mental retardation, Alzheimer's disease, Parkinson's disease, psychiatric disorders, use of psychotropic medications, history of myasthenia gravis, recent history of alcohol abuse; 8. Severe renal insufficiency (preoperative dialysis required), severe liver dysfunction (Child-Pugh class C); 9. Patients with preoperatively left ventricular ejection fraction < 30%, pathological sinus syndrome, severe sinus bradycardia (< 50 beats/min [BPM]), or atrioventricular block of 2 degrees or greater without pacemaker, are known to have a low probability of survival beyond 1 week, and emergency surgery; 10. Those with hearing or language impairment or other reasons unable to cooperate with neurocognitive assessment; 11. ASA grade IV or above; 12. Refuse to sign informed consent.

Design outcomes

Primary

MeasureTime frame
The relationship between IPH(inadvertent perioperative hypothermia) and POD(postoperative delirium);Incidence of perioperative hypothermia;Incidence of postoperative delirium;

Secondary

MeasureTime frame
Duration of delirium;Additional analgesic needs ;PACU(postanesthesia care unit) residence time;Length of stay;Intraoperative blood loss;Incidence of perioperative thermal discomfort;Incidence of myocardial injury non-cardiac surgery;Incidence of surgical site infection ;Mortality;Incidence of perioperative chills;Intraoperative blood transfusion;

Countries

China

Contacts

Public ContactShi Yongyong

Guangdong Provincial Hospital of Chinese Medicine

syy211@hotmail.com+86 13926088958

Outcome results

None listed

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