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â??Comparative study of two drugs, Fentanyl vs Clonidine when used with standard drug Bupivacaine, in patients undergoing spinal anaesthesia to find out which has better tolerance and pain relief in orthopedic procedures .â??

â??Comparative study of Bupivacaine-Fentanyl vs. Bupivacaine-Clonidine in patients undergoing spinal anaesthesia for orthopedic procedures.â??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038768
Enrollment
60
Registered
2021-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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 Health Condition 2: S829- Unspecified fracture of lower leg

Interventions

Intervention1: Spinal Anaesthesia with Bupivacaine- Fentanyl: i) Written informed consent to perform subarachnoid block will be taken from all the patients. iii) Grouping and Randomization: 100 pat
(II): On completion of the process of spinal anaesthesia
(III): Intraoperative and postoperative period till 60mins post operatively. viii) SAB were performed as per routine care and safetywith 25 gauge Quincke spinal needle via midline approach in each pa

Sponsors

Rmakrishna Mission Seva Pratisthan and Vivekananda Institute Of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Patients who gives written consent. b) ASA-I&II c) Age 18-60 years. d) Any patient posted for elective lower limb orthopedic surgery that can be done under subarachnoid block.

Exclusion criteria

Exclusion criteria: a) Patient who doesnâ??t give consent to participate. b) Any contraindication to SAB. c) Patient requiring intraoperative added any general anaesthetic aid. d) Deaf patient e) Mentally retarded patient/Dementia. f) Patient with psychiatric disorder.

Design outcomes

Primary

MeasureTime frame
Comparison of analgesic duration following, Bupivacaine-Fentanyl vs Bupivacaine-ClonidineTimepoint: Comparison of analgesic duration following, Bupivacaine-Fentanyl vs Bupivacaine-Clonidine . Pulse rate, blood pressure and SpO2 were measured. 5 minutes properatively intraoperatively every 2 minutes for first 10 minutes and every 5 minutes for next 30 minutes and every 15 minutes there after till 1 hour postoperatively—

Secondary

MeasureTime frame
Comparison of postoperative pain relief following, Bupivacaine-Fentanyl vs Bupivacaine-ClonidineTimepoint: Continuous ECG in lead II, SBP, DBP, MAP, HR, RR, SpO2 will be recorded 15 minutes before and at the time of spinal anaesthesia, then at 1 minute, at 3 minute, at 5 minute, thereafter at 5 minutes interval throughoutthe entire surgical procedure and at 15 minutes interval during first 60 minutes of post-operative period.—

Countries

India

Contacts

Public ContactDr Keya Chakraborty

RKMSP & VIMS Kolkata

drkeyachakraborty21@gmail.com9830183464

Outcome results

None listed

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