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

Comparative Study of Intrathecal Bupivacaine With FentanvI and Bupivacaine with Midazolam in Lower Abdominal and Lower Limb Surgeries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051844
Enrollment
60
Registered
2023-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: INTRATHECAL BUPIVACAINE AND FENTANYL: INTRATHECAL BUPIVACAINE 0.5% 3ml WITH FENTANYL 0.5ml 25mcg IN LOWER ABDOMINAL AND LOWER LIMB SURGERIES Control Intervention1: INTRATHECAL BUPIVACAI

Sponsors

Dr Jayant Bhatia
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 minTimepoint: baseline, 5min , 10 min, 15 min, 20 min, 30 min, 45 min, 60 min

Secondary

MeasureTime frame
TO EVALUATE QUALITY OF ANESTHESIA AND POST OPERATIVE ANALGESIATimepoint: TO MONITOR HEART RATE SP02 AT 0MIN 5 MIN 10 MIN 15 MIN 30 MIN

Countries

India

Contacts

Public ContactDrChhaya M Suryawanshi

Department of anesthesia

chhayasuryawanshi@gmail.com9922888201

Outcome results

None listed

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