Comparison of Hemodynamic Stability With 0.75percent and 0.5percent Hyperbaric Bupivacaine During Spinal Anesthesia in Cystoscopic Procedures
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 0.5% Hyperbaric Bupivicaine, 0.75% hyperbaric bupivacaine.
- Who it may be relevant to
- Registry conditions: Cystoscopy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Hemodynamic Stability With 0.75 vs 0.5percent Hyperbaric Bupivacaine During Spinal Anesthesia in Cystoscopic Procedures:A Randomized Control Trial
Overview
Purpose:The aim of this study is to determine the intrathecal Bupivacaine concentration(0.5% vs 0.75%) with better anesthesia and little hemodynamic disturbance during cystoscopic procedures.In comparing these bupivacaine concentrations ,the result would be expected to enhance safer spinal anesthesia practices ,minimizing the use of vasopressors in urological surgeries.OBJECTIVE:To compare and analyze the frequency and average chages of post spinal hemodynamic instability in terms of hypotension and bradycardia with 0.75% hyperbaric bupivacaine and 0.55 hyperbaric bupivacaine in patients presenting for cystoscopic procedures.
Detailed description
OPERATIONAL DEFINITIONS:
Hemodynamic instability:This refers to systolic blood pressure heart rate shifts of 20% more or less from baseline value after spinal anesthesia.The hemodynamic instability will be evaluated both as a numerical change and categorical variable.
Hypotensin:A qualitative variable,defined as greater than 20% drop in baseline systolic blood pressure or systolic blood pressure of less than 90mmhg after spinal anesthesia.it will be recorded for each patient as present/absent.
Bradycardia:A qualitative variable,defined as heart rate below 60 beats per minute or greater than 20% drop in baseline heart rate after spinal anesthesia.it will be recorded for each patient as present /absent.
Hyperbaric bupivacaine:Local anesthetic mixed with dextrose to increase its density more than CSF.
0.75% hyperbaric bupivacaine is 7.5mg/ml. 0.5% hyperbaric bupivacaine is 5mg/ml. HYPOTHESIS:0.5% hyperbaric bupivacaine is better than 0.75% while undergoing cystoscopy under spinal anesthesia due to its better hemodynamic stability.
Interventions
- Drug 0.5% Hyperbaric Bupivicaine
0.5% hyperbaric bupivacaine will be administered intrathecally for spinal anesthesia in patients undergoing cystoscopic procedures.hemodynamic parameters,systolic blood pressure and heart rate will be monitored, and its effects on hemodynamic stability will be assesed and compared with other intervention. - Drug 0.75% hyperbaric bupivacaine
0.75% hyperbaric bupivacaine will be administered intrathecally duringspinal anesthesia in patients undergoing cystoscopic procedures.hemodynamic parameters will be monitored ,and its effects on hemodynamic stability will be assesed and compared with 0.5% bupivacaine.
Primary outcome measures
- Measurement of frequency and mean changes in systolic blood pressure and heart rate [Time frame: From institution of spinal block upto 30 minutes]
Secondary outcome measures (1)
- Requirement for Vasopressors, Atropine ,and Intravenous fluids [Time frame: From institution of spinal block upto 30 minutes]
Eligibility criteria
Inclusion criteria
- Patients aged 18-80 years. American society of Anesthesiologist(ASA) physical status I-II. Sceduled for elective cystoscopic procedures under spinal anesthesia.
Exclusion criteria
- Patient refusal. Contraindication to spinal anesthesia(e.g coagulopathy ,infection at injection site).
Known hypersensitivity to bupivacaine. Significant cardiovascular,hepatic or renal disease.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Pakistan · 1 center
- PAEC General Hospital Islamabad — Islamabad
Identifiers
NCT: NCT07590544 · PGHI-IRB(DME)-RCD-06-074