study of occurrence of delirium after surgery using a medicine to reduce anxiety, benzodiazepine, or no medicine, in patients more than 60 years old having leg operation under regional anaesthesia

A randomized double-blind comparison of development of postoperative delirium with or without benzodiazepine premedication in elderly patients undergoing lower extremity surgery under neuraxial anaesthesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/02/031187

Enrollment

Registered

2021-02-10

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

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

Conditions

Health Condition 1: M958- Other specified acquired deformities of musculoskeletal system

Interventions

Intervention1: Benzodiazepine group: Patients will receive premedication with 0.25 mg alprazolam 2 hours before surgery Control Intervention1: Placebo group: Patients will receive premedication with p

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing elective lower extremity procedures performed under neuraxial anaesthesia

Exclusion criteria

Exclusion criteria: â?? Alcohol/drug abuse â?? Chronic benzodiazepine treatment â?? Contraindications for benzodiazepine application e.g. sleep apnea syndrome, severe chronic obstructive pulmonary disease or allergy to benzodiazepines â?? History suggestive of neurological or psychiatric disorders

Design outcomes

Primary

Measure	Time frame
Incidence of postoperative deliriumTimepoint: Days 1,2 and 3 from day of surgery	—

Secondary

Measure	Time frame
â?? Preoperative anxiety scores â?? Preoperative patient cooperation â?? Any change in mental status after surgery â?? Patient satisfaction â?? Correlation of development of delirium with patientsâ?? demographic parameters â?? Feeling of well-being and quality of sleep â?? Amnesia on 1st postoperative day â?? Hospital length of stay â?? Any health related complications within 30 postoperative days Timepoint: Before surgery and days 1,2 and 3 from day of surgery	—

Measure

Time frame

â?? Preoperative anxiety scores â?? Preoperative patient cooperation â?? Any change in mental status after surgery â?? Patient satisfaction â?? Correlation of development of delirium with patientsâ?? demographic parameters â?? Feeling of well-being and quality of sleep â?? Amnesia on 1st postoperative day â?? Hospital length of stay â?? Any health related complications within 30 postoperative days Timepoint: Before surgery and days 1,2 and 3 from day of surgery

—

Countries

India

Contacts

Public ContactDr Kuldeep Singh

University College of Medical Sciences and Guru Teg Bahadur Hospital

medhamohta@gmail.com9868399626

Outcome results

None listed

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