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

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/09/057342
• Lead Sponsor: Department of Anesthesiology, S.M.S Medical College and Attached Hospitals

Brief Summary

In this study our aim is to find out which drug is better between Midazolam versus Fentanyl used as adjuvant with 0.5% Hyperbaric Levobupivacaine in achieving prolonged postoperative analgesia in patients undergoing elective lower limb surgeries under spinal anesthesia.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-01-09
• Study Start: 2023-12-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To determine the average time for the onset of sensory block	Every 2 minutes till highest level attained
To determine the average time for the onset of motor block	Every 2 minutes till maximum motor block
To determine the average duration of sensory block	Every 30 minutes till 6 hours postoperatively
To determine the average duration of motor block	Every 30 minutes till 6 hours postoperatively
To compare the changes in cardiocirculatory parameters ( HR, SBP, DBP, MBP)	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 VAS score	Every 30 minutes for 6 hours postoperatively
Adverse events if any to be noted	24 hours

Trial Locations

Locations (1)

Sawai Man Singh Medical College and Attached Hospitals; 🇮🇳 Jaipur, RAJASTHAN, India

Sawai Man Singh Medical College and Attached Hospitals

🇮🇳Jaipur, RAJASTHAN, India

Dr Harita Haridas

Principal investigator

9544956391

haridasharita@gmail.com