PAEC General Hospital Islamabad
Islamabad, Punjab Province, 44000, Pakistan
Location contact
Dr Asghar Khan Niazi, FCPS
CONTACT
Dr Salbia Bibi, FCPS
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07590544
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Phase 4
Islamabad, Punjab Province, 44000, Pakistan
Dr Asghar Khan Niazi, FCPS
CONTACT
Dr Salbia Bibi, FCPS
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Known hypersensitivity to bupivacaine. Significant cardiovascular,hepatic or renal disease.
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.
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.
Time frame: From institution of spinal block upto 30 minutes
Measurement of frequency and mean changes in systolic blood pressure(to assess hypotension) and heart rate(to assess bradycardia)will be recorded and analyzed to evaluate the hemodynamic effects of 0.5% vs 0.75% hyperbaric bupivacaine in patients undergoing cystoscopic procedures under spinal anesthesia.
Time frame: From institution of spinal block upto 30 minutes
The need for vasopressors,atropine and iv fluids to manage hemodynamic instability during spinal anesthesia in patients undergoing cystoscopic procedures with 0.5% vs 0.75% hyperbaric bupivacaine shall also be recorded and compared.
Contact information is provided by the study sponsor or research team.
PAEC General Hospital, Islamabad
Other
Comparison of Hemodynamic Stability With 0.75 vs 0.5percent Hyperbaric Bupivacaine During Spinal Anesthesia in Cystoscopic Procedures:A Randomized Control Trial
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