RANDOMIZED DOUBLE-BLIND STUDY TO COMPARE INTRATHECAL 1% 2-CHLOROPROCAINE WITH FENTANYL AND 0.5% ROPIVACAINE WITH FENTANYL FOR SHORT SURGERIES UNDER SPINAL ANAESTHESIA.
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- . Post operative early regain of sensory block and motor block.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA I/II for selection of patient.
- •duration of surgery less than 2 hrs.
Exclusion Criteria
- •Patients Refusal 2)infection on spinal region.
- •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.
Outcomes
Primary Outcomes
. Post operative early regain of sensory block and motor block.
Time Frame: 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.
Time Frame: 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
Time Frame: 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 Outcomes
- Early ambulation after surgery(.Early discharge of patient.)