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Comparison of change in blood pressure using two different drugs for anesthesia for prostate surgery

haemodynamic effect of subarachnoid block using hyperbaric bupivacaine versus isobaric ropivacaine in patients undergoing transurethral resection of prostate: a double blind randomized controlled trial - nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085808
Enrollment
100
Registered
2025-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

Interventions

Intervention1: isobaric 0.75% ropivacaine: isobaric 0.75% ropivacaine 15mg in subarachnoid space and monitored for 3 hours for haemodynamic effect and 8 hours for sensory and motor block starting from

Sponsors

sir ganga ram hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age- 50 to 75 years 2. Body Mass Index (BMI)- 18-30 kg/m2 3. American Society of Anaesthesiology (ASA) Grade - I and II

Exclusion criteria

Exclusion criteria: 1. Inability to obtain written informed consent 2. History of hypersensitivity to local or systemic anaesthetic agents 3. Patient already on any vasopressor 4. Preoperative bradycardia or tachycardia or hypotension 5. Failure of subarachnoid block

Design outcomes

Primary

MeasureTime frame
Haemodynamic effects (hypotension) in the intraoperative periodTimepoint: every 5 min in the intraoperative period and then every 15 min in the postoperative period for a total of 3 hours followinng subarachnoid block

Secondary

MeasureTime frame
1. Bradycardia & tachycardia in the intraoperative periodTimepoint: heart rate will be monitored continuously & recorded every 5 min for the intraoperative period & then every 15 min in the postop period for 3 hours;2. Cumulative dose of vasopressor in the intraoperative periodTimepoint: Total dose of vasopressor needed in the intraoperative period will be recorded by the investigator after each operation is completed;3. Level of sensory block assessed on 5 & 10 min after subarachnoid block administrationTimepoint: 5min, 10 min following subarachnoid block;4. Duration of sensory block assessed in the postop period hourly up to 8 hoursTimepoint: 1st hour, 2nd hour, 3rd hour, 4th hour, 5th hour, 6th hour, 7th hour, 8th hour following subarachnoid block;5. Degree of motor block assessed using modified Bromage scale assessed on 5 min & 10 min after subarachnoid block administrationTimepoint: 5min, 10 min following subarachnoid block;6. Duration of motor block assessed using modified Bromage scale done hourly in the postoperative period up to 8 hoursTimepoint: 1st hour, 2nd hour, 3rd hour, 4th hour, 5th hour, 6th hour, 7th hour, 8th hour following subarachnoid block

Countries

India

Contacts

Public ContactDr Shikha sharma

sir ganga ram hospital

sshikha18@gmail.com9810382283

Outcome results

None listed

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