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

NCT07590544 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: PGHI-IRB(DME)-RCD-06-074
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystoscopy

Keywords

spinal anesthesia; hyperbaric bupivacaine; cystoscopy; hemodynamic stability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Requirement for Vasopressors, Atropine ,and Intravenous fluids

  From institution of spinal block upto 30 minutes

Study Arms (2)

0.5% hyperbaric bupivacaine group

ACTIVE COMPARATOR

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

0.75% hyperbaric bupivacaine group

ACTIVE COMPARATOR

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

Interventions

0.5% Hyperbaric Bupivicaine DRUG

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.

0.5% hyperbaric bupivacaine group

0.75% hyperbaric bupivacaine DRUG

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.

0.75% hyperbaric bupivacaine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 years. American society of Anesthesiologist(ASA) physical status I-II. Sceduled for elective cystoscopic procedures under spinal anesthesia.

You may not qualify if:

• Patient refusal. Contraindication to spinal anesthesia(e.g coagulopathy ,infection at injection site).
• Known hypersensitivity to bupivacaine. Significant cardiovascular,hepatic or renal disease.

Sponsors & Collaborators

• PAEC General Hospital, Islamabad: lead

Study Sites (1)

PAEC General Hospital Islamabad

Islamabad, Punjab Province, 44000, Pakistan

Location

Study Officials

• Dr Salbia Bibi, FCPS

  PAEC General Hospital, Islamabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Salbia Bibi, FCPS

CONTACT

+923330335004; dr.salbia@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Trainee

Model Details: 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)

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 15, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)