A Study on the Effect of Preoperative Sleep Disturbance on the Perioperative Hemodynamics in Elderly Patients Undergoing Hip Arthroplasty

A Study of the Perioperative Hemodynamic Effect of Preoperative Sleep Disturbance in Elderly Patients Undergoing Hip Arthroplasty: An Observational Clinical Study Protocol

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500095407

Enrollment

Unknown

Registered

2025-01-07

Start date

2024-12-04

Completion date

Unknown

Last updated

2025-01-13

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

Conditions

Sleep disturbances

Interventions

Preoperative sleep disorder group:no

Preoperative non-sleep disorder group:no

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age>= 65 years old, gender is not limited; 2) ASA Class I-III; 3) Patients scheduled for hip arthroplasty under general anesthesia; 4) Electronic medical record system recorder; 5) Subject agreed to participate in this study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Emergency surgery patients; 2) Subjects complicated with severe cardiovascular disease (such as myocardial ischemia, angina, heart failure and arrhythmia) before surgery; or subjects experienced myocardial infarction in past last 6 months; 3) Hypertensive subjects with unsatisfactory preoperative blood pressure control (systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >=100mmHg); 4) Subjects with a history of brain injury, intracranial hypertension, cerebral aneurysm, neuropsychiatric diseases (schizophrenia, mania, depression, dementia, stroke, epilepsy, Parkinson's, AD, cognitive impairment, etc.) or taking psychiatric drugs; 5) Subjects with endocrine system related diseases (such as hyperthyroidism, adrenal tumors) before surgery; 6) Subjects diagnosed with difficult airway (modified Marhalanobis score IV) before surgery; 7) Subjects with a history of ipsilateral hip surgery; 8) Alcohol or drug addicts; 9) Subjects who are uncooperative and unable to communicate; 10) Subjects with missing data in electronic medical record system.

Design outcomes

Primary

Measure	Time frame
Positive rate of cardiovascular response;	—

Secondary

Measure	Time frame
Pittsburgh sleep quality index (PSQI);Vital sign monitoring (ABP, HR, SpO2, BIS, PPV, T);Routine examinations and test results during the perioperative period;The time from the end of the surgery to extubation;Blood gas values;Complications during hospitalization;	—

Countries

China

Contacts

Public ContactMa Zhengliang

Nanjing Drum Tower Hospital

13611586781@163.com+86 138 5196 8286

Outcome results

None listed

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