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Comparison of medicines added to spinal anaesthesia for improving pain control during lower limb surgery in trauma patients.

A comparative study of intrathecal midazolam, clonidine, and dexmedetomidine as adjuvants to hyperbaric bupivacaine in trauma patients undergoing lower limb surgery. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100578
Enrollment
105
Registered
2026-01-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: S799- Unspecified injury of hip and thigh Health Condition 2: S899- Unspecified injury of lower leg Health Condition 3: S999- Unspecified injury of ankle and foot

Interventions

Intervention1: Intrathecal midazolam group: Hyperbaric bupivacaine 0.5 percent (2.6ml) with preservative free intrathecal midazolam 2mg (0.4ml) total volume 3ml administered intrathecally for 18 month

Sponsors

Dr Yogesh Sharma
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA (American Society of Anesthesiologists) 1 or 2 status, schedule for elective/emergency lower limb surgery under spinal anaesthesia, informed consent obtained

Exclusion criteria

Exclusion criteria: Patient refusal, known hypersensitivity to study drugs, weight less than 40kg, coagulopathy, infection at puncture site, neurological disorder, severe cardiovascular, hepatic,or renal impairment.

Design outcomes

Primary

MeasureTime frame
To compare the duration of postoperative analgesia provided by intrathecal midazolam, clonidine and dexmedetomidine as adjuent to hyperbaric bupivacaineTimepoint: From intrathecal drug administration up to 24 hours postoperatively—

Secondary

MeasureTime frame
To compare onset & duration of sensory & motor blockTimepoint: Assessed every 2 minutes after intrathecal injection until adequate block is achieved,for duration from intrathecal injection to regression of block upto 24hrs;To assess the hemodynamic stability & sedationTimepoint: Upto 24hrs from the time of intrathecal injection;To evaluate side effects such as nausea, vomiting, bradycardia, hypotension, & respiratory depressionTimepoint: Upto 24hrs from the time of intrathecal injection—

Countries

India

Contacts

Public ContactDr Rajeev Kumar Dubey

Institute of medical sciences banaras hindu university

rajeevdubeyrk@gmail.com9839927283

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026