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Effects of dexmedetomidine on postoperative sleep quality and cognitive function: a randomized controlled trial

Effects of dexmedetomidine on postoperative sleep quality and cognitive function: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040698
Enrollment
Unknown
Registered
2020-12-08
Start date
2020-12-06
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

REM

Interventions

A:0.2ug/kg/h dexmedetomidine was pumped for 1h at the beginning of the operation.
B:0.7ug/kg/h dexmedetomidine was pumped for 1h at the beginning of the operation.
C:200ug dexmedetomidine (200ug/100ml, 2ml/h, 4ug/h) was added to the postoperative analgesia pump.
D:No dexmedetomidine use perioperatively

Sponsors

The Fourth Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: All subjects must meet the following inclusion criteria: (1) Patients undergoing elective general anesthesia are not limited to gender; (2) ASA I to III; (3) Aged 18 to 75 years; (4) Not received chemotherapy or related immunotherapy before; (5) Voluntary participation in clinical trials and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) The patient refuses; (2) Second or third degree atrioventricular block in patients with sinus bradycardia; (3) Acute heart failure unstable anginascreening for myocardial infarction in the first 6 months resting ECG heart rate 50 times/min, serious arrhythmias such as third degree atrioventricular block severe heart diseases of the heart valves; QTc: Male >=450 ms, female >=470 ms; (4) Obvious abnormality of liver and kidney function: liver function: TBIL, ALT, AST more than 2.5 ULN; Renal function: serum creatinine (Cr) & GT; 1.5 ULN; (5) A history of neuropsychiatric illness and long-term use of anti-psychotropic drugs; (6) A history of epilepsy; (7) Other neurological diseases that may significantly affect the quality of sleep; (8) A history of drug abuse and/or alcohol abuse in the 2 years prior to screening, i.e. an average of more than 2 units of alcohol per day; Fine (1 unit =360 mL beer or 45 mL 40% spirit or 150 mL wine); (9) Abnormal body temperature before operation, respiratory tract, lung or other site infection; (10) Patients with immune system diseases, history of chemoradiotherapy and application of immunosuppressive drugs such as hormones; (11) Patients with hearing impairment or impaired understanding and communication; (12) Pregnant or lactating female patients; Women of childbearing age who refuse to accept contraceptive measures; (13) Other conditions in which the investigator considers it inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Electroencephalogram;Total sleep duration;Sleep duration at night;Duration of NREM I, II, III, IV;The proportion of background fast wave sleep occurring in large amounts in EEG background activity.;

Secondary

MeasureTime frame
Subjective sleep quality of patients;Postoperative personality changes of patients;Cognitive function assessment;Inflammatory cytokines;

Countries

China

Contacts

Public ContactLiu Yan

The Fourth Hospital of Hebei Medical University

258158601@qq.com+86 13582118982

Outcome results

None listed

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