Effects of dexmedetomidine early admission on postoperative delirium in elderly patients with hip fracture

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200064643

Enrollment

Unknown

Registered

2022-10-13

Start date

2022-10-01

Completion date

Unknown

Last updated

2023-08-28

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

Conditions

Postoperative delirium

Interventions

Group D:Intravenous dexmedetomidine hydrochloride was given the night before surgery

Group C:Saline was given intravenously the night before surgery

Eligibility

Sex/Gender

All

Age

60 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age >=65 years old; 2. ASA Grade I-III; 3. Elective hip fracture surgery was performed under spinal anesthesia due to hip fracture

Exclusion criteria

Exclusion criteria: 1. Preoperative cognitive impairment (assessed by 3D-CAM); 2. History of mental or neurological disease and current use of psychotropic drugs; 3. History of other serious systemic diseases, such as severe liver,kidney , heart, brain and lung dysfunction; 4. Heart rate &lt indicated by ECG; 50 beats/min or severe conduction block; 5. Impaired communication due to coma, severe dementia, and impaired speech and hearing 6. Study drug allergies 7. Revision of prosthetic fractures or multiple fractures requiring surgical treatment; 8. Refuse to sign the consent form

Design outcomes

Primary

Measure	Time frame
Incidence of postoperative delirium;	—

Secondary

Measure	Time frame
Leeds Sleep Evaluation Questionnaire, LSEQ;Adverse events during intervention (hypertension, hypotension, bradycardia);Adverse events (hypertension, hypotension, bradycardia);Length of stay;30 days postoperative all-cause mortality;Pain score;Opioid consumption;Melatonin levels of Baseline and surgery day;IL-6 levels of Baseline and surgery day;Postoperative adverse events;Severity of postoperative delirium;Wake times;Insomnia severity index scale(ISI);NRS-sleep;Total sleep time;sleep latency;Sleep diary and actigraphy;	—

Measure

Time frame

Leeds Sleep Evaluation Questionnaire, LSEQ;Adverse events during intervention (hypertension, hypotension, bradycardia);Adverse events (hypertension, hypotension, bradycardia);Length of stay;30 days postoperative all-cause mortality;Pain score;Opioid consumption;Melatonin levels of Baseline and surgery day;IL-6 levels of Baseline and surgery day;Postoperative adverse events;Severity of postoperative delirium;Wake times;Insomnia severity index scale(ISI);NRS-sleep;Total sleep time;sleep latency;Sleep diary and actigraphy;

—

Countries

China

Contacts

Public ContactGeng Pengcheng

Lu 'an Hospital affiliated to Anhui Medical University

gpcllnn219720@163.com+86 158 5640 2630

Outcome results

None listed

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