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To compare bispectral index value between bupivacaine 0.5% heavy and bupivacaine 0.5 % heavy with fentanyl under spinal anaesthesia

A COMPARATIVE STUDY OF BISPECTRAL INDEX VALUE UNDER SPINAL ANAESTHESIA IN ADULT PATIENTS WITH BUPIVACAINE 0.5 PERCENT HEAVY VERSUS BUPIVACAINE 0.5 PERCENT HEAVY WITH FENTANYL 10mcg-A PROSPECTIVE RANDOMIZED STUDY - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/114008
Enrollment
60
Registered
2026-07-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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: Bupivacaine 0.5 Percent HEAVY 2.5 ml and fentanyl 10 mcg: Subarachnoid block with Bupivacaine 0.5% HEAVY 2.5 ml and fentanyl 10 mcg Control Intervention1: Bupivacaine 0.5 percent HEAV

Sponsors

BHAVANA P
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult Male patients between 18-60 years of age. Adult Female patients between 18-60 years of age. Patients willing to give informed consent. Patients under ASA 1,ASA 2 and ASA3 scheduled for elective surgery under subarachnoid block.

Exclusion criteria

Exclusion criteria: Uncontrolled systemic disorder. ASA-4, ASA-5. Contraindication to central neuraxial blockade. Neurological impairment. Demyelinating disease. Psychoactive Medications/Substance abuse. Patient refusal. Known allergy to study drugs.

Design outcomes

Primary

MeasureTime frame
To compare Bispectral index value between the two study groups after subarachnoid block in adult patients .Timepoint: 0,5,10,15,20,25,30,35,40,45,50,55, 60 minutes

Secondary

MeasureTime frame
Level of spinal anaesthesia, hemodynamic stability such as heart rate, blood pressure, spO2, any adverse effectsTimepoint: 0,5,10,15,20,25,30,35,40,45,50,55, 60 minutes

Countries

India

Contacts

Public ContactV Y SRINIVAS

Mysore Medical college and research institute

drsrinivasvy@gmail.com9448165082

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026