Efficacy of two doses of dexmedetomidine as an adjuvant to intrathecal hyperbaric levobupivacaine in lower limb surgeries - a randomized control trial

Efficacy and Safety of different doses of Dexmedetomidine with Hyperbaric Levobupivacaine under Spinal Anaesthesia in lower limb surgeries – A Randomized Control Trial. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/060207

Enrollment

Registered

2023-11-23

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

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

Conditions

Health Condition 1: T240- Burn of unspecified degree of lower limb, except ankle and foot Health Condition 2: S772- Crushing injury of hip with thigh Health Condition 3: S878- Crushing injury of lower leg Health Condition 4: S723- Fracture of shaft of femur Health Condition 5: S822- Fracture of shaft of tibia Health Condition 6: S760- Injury of muscle, fascia and tendon of hip Health Condition 7: S828- Other fractures of lower leg Health Condition 8: S798- Other specified injuries of hip and thi

Interventions

Intervention1: Administration of Spinal Anaesthesia using Hyperbaric Levobupivacaine with Dexmedetomidine as adjuvant.: Patient will receive 3.0 mL (15.0 mg) of 0.5% hyperbaric levobupivacaine by intr

Eligibility

Inclusion criteria

Inclusion criteria: ? Age between 18-60 years. ? American Society of Anesthesiologists (ASA) physical grade I and II. ? Patients undergoing elective lower limb surgeries.

Exclusion criteria

Exclusion criteria: ?BMI > 30kg/m2 ? Patients with known history of allergy to the study medications. ? Patients with coagulative disorders, neurological disorders, hepatic and renal insufficiency. ? Patients unwilling to participate in the study.

Design outcomes

Primary

Measure	Time frame
Intraoperative analgesia at the desired dermatome level T8 is the primary outcome measure.Timepoint: 15 minutes and 30 minutes, then every 30 minutes until the block recedes to the desired dematomal level.	—

Secondary

Measure	Time frame
? The intensity of motor blockade is assessed by the modified Bromage scale. ? Intraoperative hemodynamic changes in HR, Systolic Blood Pressure (SBP), Diastolic Blood Pressure(DBP), Mean Arterial Pressure (MAP) and O2 saturation (SpO2) are assessedTimepoint: 1. Modified Bromage Scale - 15 minutes and 30 minutes, then every 30 minutes. 2. SBP,DBP,MAP and SpO2 assessment - at induction and after every 5 mins till 15 mins.	—

Measure

Time frame

? The intensity of motor blockade is assessed by the modified Bromage scale. ? Intraoperative hemodynamic changes in HR, Systolic Blood Pressure (SBP), Diastolic Blood Pressure(DBP), Mean Arterial Pressure (MAP) and O2 saturation (SpO2) are assessedTimepoint: 1. Modified Bromage Scale - 15 minutes and 30 minutes, then every 30 minutes. 2. SBP,DBP,MAP and SpO2 assessment - at induction and after every 5 mins till 15 mins.

—

Countries

India

Contacts

Public ContactAnmol Bhujabal

Kalinga Institute of Medical Sciences, Bhubaneswar

ganesh.satapathy@kims.ac.in8283872939

Outcome results

None listed

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