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Regional anaesthesia with three different drug doses in sick and elderly patients with hip fracture

Anaesthetic management of high risk orthopedic patients with combined sequential spinal epidural using three different doses of intrathecal ropivacaine - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093494
Enrollment
60
Registered
2025-08-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue Health Condition 2: M80- Osteoporosis with current pathological fracture Health Condition 3: M800- Age-related osteoporosis with current pathological fracture Health Condition 4: M800- Age-related osteoporosis with current pathological fracture Health Condition 5: O- Medical and Surgical

Interventions

Intervention1: Combined sequential spinal epidural anaesthesia: With the approval of the Institutional Ethical Committee, a total of 60 patients will be randomly allocated into either of the three gr

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with ASA III & above 2.Heart disease with systolic & diastolic dysfunction 3.IHD with no indication/unwilling for pre-procedure intervention 4.Patients of either sex above 75 yrs of age irrespective of other comorbidities 5.Patients of uncontrolled DM 6.Elective /emergency surgery

Exclusion criteria

Exclusion criteria: 1.Patients <65 yrs 2.Contraindication of CSEA/SAB 3.Not willing

Design outcomes

Primary

MeasureTime frame
The primary objective is to compare the hemodynamic stability measured in terms of fall in MAP 30% from baseline.Timepoint: Every 5 minutes, upto 30 minutes and then every 15 minutes till completion of surgery.

Secondary

MeasureTime frame
1. Incidence of bradycardia 2. Time needed to achieve bromage 3 (complete motor paralysis) 3. Time needed to reach sensory T10 4. Volume of epidural bupivacaine to reach sensory T10 5. Surgeon satisfaction 6. Patient satisfaction 7. Adverse events if any Timepoint: Whenever incidences are noticed from start of anaesthesia till completion of surgery

Countries

India

Contacts

Public ContactSathyasuba Meenakshi sundaram

BIHER

drsathyasuba@gmail.com9791421124

Outcome results

None listed

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