A Clinical trial to study the effect of two drugs,chloroprocaine and ropivacaine with adjuvant fentanyl in spinal anaesthesia for short surgeries

Phase 3

Not yet recruiting

• Conditions: healthy human volunteers of both the sex with age group of( 18 to 65yrs) for short surgeries under spinal anaesthesia; Medical and Surgical,

• Registration Number: CTRI/2021/08/035513
• Lead Sponsor: Bharati Vidyapeeth Deemed To Be University Medical College and Research Centre Pune

Brief Summary

The study is randomized ,double blind, trial comparing the efficacy between the two drugs intrathecal 1% 2- chloroprocaine  and 0.5% ropivacaine with adjuvant fentany  (12.5 mcg)l in spinal anaesthesia for short surgeries . primary outcome  will be duration of anaesthesia and haemodynamic stability, secondary outcome will be early ambulation and early discharge.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-04-08
• Study Start: 2021-08-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• 1)ASA I/II for selection of patient.
• 2)duration of surgery less than 2 hrs.

Exclusion Criteria

• 1)Patients Refusal 2)infection on spinal region.
• 3)Patients with a history of severe cardiovascular disease, steroid use, renal or hepatic dysfunction and mental retardation 4)Known sensitivity to the drug to be used 5)Patients on anticoagulant therapy, coagulation disorder 6)Intolerance to Atypical plasma cholinesterase.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
. Post operative early regain of sensory block and motor block.	observation of motor and sensory block after spinal anaesthesia in short surgeries every 5 mins for 20 mins then every 10 mins upto end of surgery | 2.Heart rate ,systolic blood pressure, diastolic blood pressure ,respiratory rate , oxygen saturation for every 5 mins for 10 minutes then every 10 minutes upto end of surgery
Haemodynamic stability after giving spinal anaesthesia in short surgeries.	observation of motor and sensory block after spinal anaesthesia in short surgeries every 5 mins for 20 mins then every 10 mins upto end of surgery | 2.Heart rate ,systolic blood pressure, diastolic blood pressure ,respiratory rate , oxygen saturation for every 5 mins for 10 minutes then every 10 minutes upto end of surgery
. Duration of surgery	observation of motor and sensory block after spinal anaesthesia in short surgeries every 5 mins for 20 mins then every 10 mins upto end of surgery | 2.Heart rate ,systolic blood pressure, diastolic blood pressure ,respiratory rate , oxygen saturation for every 5 mins for 10 minutes then every 10 minutes upto end of surgery

Secondary Outcome Measures

Name	Time	Method
Early ambulation after surgery	.Early discharge of patient.

Trial Locations

Locations (1)

Bharati Vidyapeeth (Deemed To Be ) Medical College and Research Centre, Pune.; 🇮🇳 Pune, MAHARASHTRA, India

Bharati Vidyapeeth (Deemed To Be ) Medical College and Research Centre, Pune.

🇮🇳Pune, MAHARASHTRA, India

Dr Deshmukh Aishwarya Shrinivas

Principal investigator

08217474217

Aishudeshmukh222@gmail.com