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A Comparison of Efficacy between Low-Dose Dexmedetomidine and Propofol for Prophylaxis of Postoperative Delirium in Elderly Patients Undergoing Hip Fracture Surgery: A Randomized Controlled Trial

A Comparison of Efficacy between Low-Dose Dexmedetomidine and Propofol for Prophylaxis of Postoperative Delirium in Elderly Patients Undergoing Hip Fracture Surgery: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190522001
Enrollment
111
Registered
2019-05-22
Start date
2019-05-27
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Postoperative delirium Postoperative delirium,Dexmedetomidine, Propofol,Hip surgery

Interventions

Dexmedetomidine (4 mcg/ml) 0.2 mcg/kg/hr IV continuous drip&#44
no bolus dose&#44
max 0.7 mcg/kg/hr,Propofol (10 mg/ml) 0.5 mg/kg/hr (8.3 mcg/kg/min) IV continuous drip&#44
no bolus&#44
max 1.75 mg/kg/hr (29 mcg/kg/min),Normal saline 2.5 ml/hr IV continuous drip
Active Comparator Drug,Active Comparator Drug,Active Comparator Drug
Dexmedetomidine,Propofol,Placebo

Sponsors

Ratchadapiseksompod fund
Lead Sponsor
Ratchadapiseksompod fund
Collaborator

Eligibility

Sex/Gender
All
Age
60 Years to 100 Years

Inclusion criteria

Inclusion criteria: - Age 60 years old or older - Admit post-operative in ICU - Closed fracture intertrochanteric or neck of femur - ASA (American Society of Anesthesiologists) class 2-3 - BMI 18 - 40 kg/m2

Exclusion criteria

Exclusion criteria: - Patient refusal - Allergy to drugs used in this research - Richmond Agitation Sedation Scale (RASS) less than - 2 before sedation - Prior delirium or dementia - Prior or acute cerebrovascular disease - Bradycardia eg. Second or Third-degree atrioventricular block - Prior temporary or permanent pacemaker - Bradycardia (HR less than 50 bpm) of different origin - Severe congestive heart failure - Obstructive sleep apnea - Severe chronic obstructive pulmonary disease - Seizure or status epilepticus - Delirium tremens and alcohol withdrawal - Substance abuse with acute experience of acute withdrawal

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative delirium Postoperative period CAM-ICU

Secondary

MeasureTime frame
Drugs side effects and complication Postoperative period Medical record,Fentanyl consumption Postoperative period Medical record and recording from patient-controlled analgesia (PCA) machine,Length of hospital stay Postoperative period Medical record,Postoperative Thai Mental State Examination (TMSE) Postoperative period Examine by psychiatrists

Countries

Thailand

Contacts

Public ContactGamonmas Ekkapat

Faculty of Medicine, Chulalongkorn University

gamonmas@yahoo.com0894950088

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026