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Effect of intrEffect of intravertebral anesthesia assisted dexmedetomidine sedation on circadian rhythm in patients undergoing lower limb orthopedic surgery

Effect of intravertebral anesthesia assisted dexmedetomidine sedation on circadian rhythm in patients undergoing lower limb orthopedic surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000028954
Enrollment
Unknown
Registered
2020-01-09
Start date
2020-01-01
Completion date
Unknown
Last updated
2021-05-17

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

Conditions

Circadian rhythm

Interventions

The control group:Physiological salt pumping
Experimental group:Dexmedetomidine hydrochloride pumping

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) The American college of anesthesiologists (ASA) grades are grades I to III; (2) Elective surgery; (3) Patients undergoing lower extremity orthopedic surgery under intravertebral anesthesia; (4) Aged 18-65 years.

Exclusion criteria

Exclusion criteria: (1) Patients with operation time less than 30 min; (2) Women who are pregnant or breastfeeding; (3) Abnormal liver function, ALT and/or AST > 1.5 times the upper limit of normal value; (4) Abnormal renal function, Cr and/or BUN > 1.5 times the upper limit of normal value;Dialysis patients; (5) Diabetic patients whose blood glucose was not controlled satisfactorily (fasting blood glucose >= 11.1mmol/L in screening period); (6) The physical condition of the patient is difficult to evaluate the efficacy (such as severe central nervous system surgery or intracranial surgery); Patients with psychiatric disorders (such as schizophrenia, depression) and cognitive dysfunction; Patients with a history of epilepsy; History of cerebrovascular disease; Previous history of abuse of psychotropic drugs and narcotic drugs; Alcohol is invisible; (7) Take benzodiazepines, hormones, beta-blockers, clonidine, ibuprofen and naloxone for the previous 7 days; (8) Patients who need intravenous compound propofol and opioid for poor intraoperative anesthetic effect; (9) Patients who are allergic to the tested drugs; (10) Participate in clinical trials of other drugs within 3 months; (11) The patient does not agree to use the epidural analgesia pump, or the epidural analgesia pump falls off halfway; (12) Other circumstances in which the investigator determines that the patient is not fit to participate in the clinical trial.

Design outcomes

Secondary

MeasureTime frame
Nighttime sleep duration;Daytime sleeping time;Night sleep stage: deep sleep time, light sleep time, rapid eye movement time, sleep cycle awake time;Daytime sleep stage: deep sleep time, light sleep time, rapid eye movement time, sleep cycle awake time;VAS score;

Primary

MeasureTime frame
Deep sleep quality score;Urinary dopamine concentration;Urine concentration of 5 - HT;Urine endorphin levels;Urinary melatonin concentration;

Countries

China

Contacts

Public ContactQingping Wu

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

wqp1968@163.com+86 13971605283

Outcome results

None listed

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