A comparision between intrathecal bupivacaine with fentanyl and bupivacaine with midazolam in lower abdominal and lower limb surgeries

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/04/051844
• Lead Sponsor: Dr Jayant Bhatia

Brief Summary

IT IS A PROSPECTIVE COMPARATIVE RANDOMISED DOUBLE BLINDED STUDY WHERE IN INTRATHECAL BUPIVACAINE WITH FENTANYL AND INTRATHECAL BUPOVACAINE WITH MIDAZOLAM ARE COMPARED FOR ONSET QUALITY OF ANESTHESIA AND POST OPERATIVE ANALGESIA IN PATIENTS UNDERGOING LOWER ABDOMINAL AND LOWER LIMB SURGERIES

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-04-20
• Study Start: 2023-04-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA grade I or II fit patients Ages between 18 and 60 years Patients undergoing lower abdominal and lower limb surgeries under spinal anesthesia Haemodynamically stable patients with all routine investigations within normal limits without any other co morbidities.
• Patients who are not on any cardiac related drugs.
• Availability of written informed consent from concerned patient.

Exclusion Criteria

• Patients not willing to get enrolled in this study Patients with ASA physical status III or more Patients below 18 years and above 60 years of age Patients posted for emergency procedures Patients with uncontrolled systemic disorders like diabetes mellitus, heart disease, chronic hypertension, pulmonary disorders, etc Patients with spine deformities or local skin interactions overlying the lumbar vertebral region Patients with bleeding or coagulation disorders.
• Patients with known allergies to the study drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TO STUDY THE ONSET OF MOTOR AND SENSORY BLOCK AND DURATION OF ANALEGESIA WITH ADDITION OF MIDAZOLAM OR FENTANYL TO 0.5%BUPIVACAINE HEAVY IN SUB ARACHNOID BLOCK -baseline, 5min 10 min 15 min 20 min 30 min 45 min 60 min	baseline, | 5min , | 10 min, | 15 min, | 20 min, | 30 min, | 45 min, | 60 min

Secondary Outcome Measures

Name	Time	Method
TO EVALUATE QUALITY OF ANESTHESIA AND POST OPERATIVE ANALGESIA	TO MONITOR HEART RATE SP02 AT 0MIN 5 MIN 10 MIN 15 MIN 30 MIN

Trial Locations

Locations (1)

Dr DY Patil medical college and hospital research centre pimpri pune; 🇮🇳 Pune, MAHARASHTRA, India

Dr DY Patil medical college and hospital research centre pimpri pune

🇮🇳Pune, MAHARASHTRA, India

Dr Jayant Bhatia

Principal investigator

9911766166

jayant.bhatia0134@gmail.com