Comparison of Hemodynamic Stability With 0.75percent and 0.5percent Hyperbaric Bupivacaine During Spinal Anesthesia in Cystoscopic Procedures

Comparison of Hemodynamic Stability With 0.75 vs 0.5percent Hyperbaric Bupivacaine During Spinal Anesthesia in Cystoscopic Procedures:A Randomized Control Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cystoscopy
• Intervention / Treatment: Drug: 0.5% Hyperbaric Bupivicaine; Drug: 0.75% hyperbaric bupivacaine

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dr Salbia Bibi, FCPS; Phone Number: +923330335004; Email: dr.salbia@yahoo.com

Study Locations

• Pakistan
  • Punjab Province
    • Islamabad, Punjab Province, Pakistan, 44000
      • PAEC General Hospital Islamabad
      • Contact: Dr Asghar Khan Niazi, FCPS; Phone Number: +923325061749; Email: asghar852@yahoo.com
      • Principal Investigator: Dr Salbia Bibi, FCPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.5% hyperbaric bupivacaine group; Patients will receive spinal anesthesia with 0.5% hyperbaric bupivacainefor cystoscopic procedures.hemodynamic parameters will be monitored and compared with other group.	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.
Active Comparator: 0.75% hyperbaric bupivacaine group; Patients will receive spinal anesthesia with 0.75% hyperbaric bupivacaine for cystoscopic procedures.hemodynamic stability and related outcomes will be assesed and compared with 0.5% group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of frequency and mean changes in systolic blood pressure and heart rate	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.	From institution of spinal block upto 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Requirement for Vasopressors, Atropine ,and Intravenous fluids	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.	From institution of spinal block upto 30 minutes

Collaborators and Investigators

• Sponsor: PAEC General Hospital, Islamabad
• Investigators: Principal Investigator: Dr Salbia Bibi, FCPS, PAEC General Hospital, Islamabad

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 10, 2026
• First Submitted That Met QC Criteria: May 10, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 10, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: spinal anesthesia; cystoscopy; hemodynamic stability; hyperbaric bupivacaine
• Other Study ID Numbers: PGHI-IRB(DME)-RCD-06-074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As the hospital where this study is being conducted does not allow to share any collected data with other researches due to patient confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No