Two drug comparison of low dose of Ropivacaine with Fentanyl and low dose Bupivacaine with Fentanyl which will be givengiven via spinal anesthesia to know which drug combination is better in anesthetizing the required surgical area and cause less side effects in Transurethral surgery of prostate.

Comparative evaluation of low dose ropivacaine with fentanyl and low dose bupivacaine with fentanyl in subarachnoid block in TURP. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076498

Enrollment

Registered

2024-11-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: COMPARATIVE EVALUATION OF LOW DOSE ROPIVACAINE WITH FENTANYL AND LOW DOSE BUPIVACAINE WITH FENTANYL IN SUBARACHNOID BLOCK FOR TRANSURETHRAL RESECTION OF PROSTATE: STUDY(PROSPECTIVE INTE

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 40-80 years undergoing TURP. 2. Patients classified as American Society of Anesthesiologists (ASA) grade I and II. 3. Patients weighing between 40-80 kilograms. 4. Patients with a height ranging from 150 to 180 centimeters.

Exclusion criteria

Exclusion criteria: 1. Refusal to participate in the study. 2. Known allergy to any drugs used in the study. 3. Presence of spinal deformity or focal neurological deficits. 4. Infection at the proposed site of subarachnoid block. 5. Body Mass Index (BMI) greater than 40. 6. Contraindications to subarachnoid block. 7. Coagulation disorders, inability to understand the Visual Analogue Scale (VAS), or prostate weight exceeding 70 grams.

Design outcomes

Primary

Measure	Time frame
• INTRA OPERATIVE: 1.Onset Time to T10 level of sensory block. 2.Time to maximum sensory and maximum motor block level. 3.Total duration of sensory and motor block. • POST OPERATIVE: 1. Time to first analgesic requirement will be evaluated and recorded. 2. Regression of motor block using modified bromage score. 3.Post operative pain (using visual analogue scale 0-10). 4.Time to discharge(decided by the Modified Aldrete Scoring system). Timepoint: BLOCK characteristics(sensory and motor block) and haemodynamic parameters will be checked at-0 mins, 1 mins, 3mins, 5mins, 10mins, 15mins, 20 mins and every 10 minutes till patient is shifted to recovery room. From arrival in PACU ( parameter to be checked are- SBP, DBP, Sensory block , Motor block , VAS score , Modified Aldrete score)- 0min, 15 min, 30 min, 45min, and every 15 min.	—

Measure

Time frame

• INTRA OPERATIVE: 1.Onset Time to T10 level of sensory block. 2.Time to maximum sensory and maximum motor block level. 3.Total duration of sensory and motor block. • POST OPERATIVE: 1. Time to first analgesic requirement will be evaluated and recorded. 2. Regression of motor block using modified bromage score. 3.Post operative pain (using visual analogue scale 0-10). 4.Time to discharge(decided by the Modified Aldrete Scoring system). Timepoint: BLOCK characteristics(sensory and motor block) and haemodynamic parameters will be checked at-0 mins, 1 mins, 3mins, 5mins, 10mins, 15mins, 20 mins and every 10 minutes till patient is shifted to recovery room. From arrival in PACU ( parameter to be checked are- SBP, DBP, Sensory block , Motor block , VAS score , Modified Aldrete score)- 0min, 15 min, 30 min, 45min, and every 15 min.

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Secondary

Measure	Time frame
• SECONDARY OBJECTIVES: 1.To compare onset time to T10 level of sensory block in both the groups. 2.To compare time to maximum sensory block level in both the groups. 3.To compare time to maximum motor block level in both the groups. 4.To note any hemodynamic changes (Heart rate, Systolic Blood pressure, Diastolic Blood pressure), adverse effects and any other observation, if any.Timepoint: sample size -80 each group	—

Measure

Time frame

• SECONDARY OBJECTIVES: 1.To compare onset time to T10 level of sensory block in both the groups. 2.To compare time to maximum sensory block level in both the groups. 3.To compare time to maximum motor block level in both the groups. 4.To note any hemodynamic changes (Heart rate, Systolic Blood pressure, Diastolic Blood pressure), adverse effects and any other observation, if any.Timepoint: sample size -80 each group

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Countries

India

Contacts

Public ContactDr Sanjay Kumar Gupta

HINDU RAO HOSPITAL AND NDMC MEDICAL COLLEGE

drskgupta4u@gmail.com9810655949

Outcome results