To find out which drug is better between Midazolam versus Fentanyl when used as an adjuvant with 0.5% hyperbaric Levobupivacaine in achieving prolonged post operative pain relief in patients undergoing elective lower limb surgeries under spinal anesthesia

Phase 3

Lead Sponsor: Department of Anesthesiology, S.M.S Medical College and Attached Hospitals

Recruitment & Eligibility

Inclusion Criteria

1. Patient willing to participate in the study with written informed consent

2. Patients age between 20 to 60 years

3. Height of the patient is more than 145 cms

4. Patients undergoing elective lower limb surgeries

5. Patients belonging to ASA physical status I or II

Exclusion Criteria

1. Patients with bacteremia sepsis or skin infection of local site

2. Patient with severe hypovolemia or anemia or compromised renal cardiac or respiratory status

3. Patients with raised intracranial tension

4. Patients with abnormal coagulation profile

5. Patients allergic to drugs used for study

6. Uncooperative patients

7. Patients in whom spinal anesthesia failed and general anesthesia was required

Primary Outcome Measures

Name	Time	Method
To determine the average time for the need of first dose of rescue analgesiaTimepoint: Every 30 minutes for 6 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Adverse events if any to be notedTimepoint: 24 hours;To compare the changes in cardiocirculatory parameters ( HR, SBP, DBP, MBP)Timepoint: Every 5 minutes for first 30 minutes followed by every 10 minutes till completion of surgery then every 30 minutes for 6 hours postoperatively;To determine the average duration of motor blockTimepoint: Every 30 minutes till 6 hours postoperatively;To determine the average duration of sensory blockTimepoint: Every 30 minutes till 6 hours postoperatively;To determine the average time for the onset of motor blockTimepoint: Every 2 minutes till maximum motor block;To determine the average time for the onset of sensory blockTimepoint: Every 2 minutes till highest level attained;To determine the VAS scoreTimepoint: Every 30 minutes for 6 hours postoperatively