Cystoscopy
Conditions
Keywords
spinal anesthesia, hyperbaric bupivacaine, cystoscopy, hemodynamic stability
Brief summary
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
DRUG0.5% 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.
DRUG0.75% 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.
Sponsors
PAEC General Hospital, Islamabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Study design:Randomized control trial(RCT).Setting:Department of anesthesia ,Pakistan Atomic Energy Commission General Hospital,Islamabad. Duration:06 months(after approval of synopsis by CPSP)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of frequency and mean changes in systolic blood pressure and heart rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Requirement for Vasopressors, Atropine ,and Intravenous fluids | 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. |
Countries
Pakistan
Contacts
CONTACTDr Salbia Bibi, FCPS
PRINCIPAL_INVESTIGATORDr Salbia Bibi, FCPS
PAEC General Hospital, Islamabad
Outcome results
None listed