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NCT Number: NCT07590544

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

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

PAEC General Hospital Islamabad

Islamabad, Punjab Province, 44000, Pakistan

Location contact

Dr Asghar Khan Niazi, FCPS

CONTACT

[email protected]

+923325061749

Dr Salbia Bibi, FCPS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

0.75% 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.

Primary outcomes

  1. Measurement of frequency and mean changes in systolic blood pressure and heart rate

    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.

Secondary outcomes

  1. Requirement for Vasopressors, Atropine ,and Intravenous fluids

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Salbia Bibi, FCPS

CONTACT

[email protected]

+923330335004

Sponsors and collaborators

Lead sponsor

PAEC General Hospital, Islamabad

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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