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

RANDOMIZED DOUBLE-BLIND STUDY TO COMPARE INTRATHECAL 1% 2-CHLOROPROCAINE WITH FENTANYL AND 0.5% ROPIVACAINE WITH FENTANYL FOR SHORT SURGERIES UNDER SPINAL ANAESTHESIA.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/035513

Enrollment

Registered

2021-08-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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 inj 0.5% ropicacaine.: 0.5% ropivacaine (3cc) with adjuvant inj fentanyl 12.5 mcg Control Intervention1: intrathecal inj 1% 2-chloroprocaine: 1% 2-chloroprocaine with adjuva

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
. Post operative early regain of sensory block and motor block. Haemodynamic stability after giving spinal anaesthesia in short surgeries. . Duration of surgery Timepoint: 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	—

Measure

Time frame

. Post operative early regain of sensory block and motor block. Haemodynamic stability after giving spinal anaesthesia in short surgeries. . Duration of surgery Timepoint: 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

Measure	Time frame
Early ambulation after surgery .Early discharge of patient.Timepoint: .NIBP, heart rate, and SpO2 will be recorded. Sensory and motor block will be assessed every 15 minutes for 60 min and then every 30 minutes until complete regression .Patient will be shifted to, ward from PACU when modified Aldert score would be â?¥ 9. In the ward time of ambulation that is stand without support and walk and time of voiding of urine will be noted	—

Measure

Time frame

Early ambulation after surgery .Early discharge of patient.Timepoint: .NIBP, heart rate, and SpO2 will be recorded. Sensory and motor block will be assessed every 15 minutes for 60 min and then every 30 minutes until complete regression .Patient will be shifted to, ward from PACU when modified Aldert score would be â?¥ 9. In the ward time of ambulation that is stand without support and walk and time of voiding of urine will be noted

—

Countries

India

Contacts

Public ContactDR POOJA NARAYAN BHOSLE

Bharati Vidyapeeth ( Deemed to be university) medical college and research center,Dhankawadi ,pune

bhosle_pooja@yahoo.co.in8128658765

Outcome results

None listed

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