CystoscopyPhase 4NCT07590544
Comparison of Hemodynamic Stability With 0.75percent and 0.5percent Hyperbaric Bupivacaine During Spinal Anesthesia in Cystoscopic Procedures
A Phase 4 study testing 0.5% Hyperbaric Bupivicaine and 0.75% hyperbaric bupivacaine in people with Cystoscopy, run by PAEC General Hospital, Islamabad at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cystoscopy
- What is being tested?
- 0.5% Hyperbaric Bupivicaine and 0.75% hyperbaric bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2026to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years. American society of Anesthesiologist(ASA) physical status I-II. Sceduled for elective cystoscopic procedures under spinal anesthesia.
Who cannot join
- Patient refusal. Contraindication to spinal anesthesia(e.g coagulopathy ,infection at injection site).
- Known hypersensitivity to bupivacaine. Significant cardiovascular,hepatic or renal disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
PAEC General Hospital Islamabad
Islamabad, Punjab Province, 44000
Dr Asghar Khan Niazi, FCPS, +923325061749, asghar852@yahoo.com
Dr Salbia Bibi, FCPS
About this study
Official title: 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.
Read the 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.
- Conditions
- Cystoscopy
- Being tested
- 0.5% Hyperbaric Bupivicaine, 0.75% hyperbaric bupivacaine
- Keywords
- spinal anesthesia, hyperbaric bupivacaine, cystoscopy, hemodynamic stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% Hyperbaric BupivicaineDrug
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 bupivacaineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 0.75% hyperbaric bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From institution of spinal block upto 30 minutes
Secondary outcomes (1)
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.
Measured: From institution of spinal block upto 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PAEC General Hospital, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salbia Bibi, PAEC General Hospital, Islamabad
- Investigators
- Dr Salbia Bibi, FCPS, Principal investigator, PAEC General Hospital, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590544
- Sponsor's protocol ID
- PGHI-IRB(DME)-RCD-06-074
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As the hospital where this study is being conducted does not allow to share any collected data with other researches due to patient confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hemodynamic Stability With 0.75 vs 0.5percent Hyperbaric Bupivacaine During Spinal Anesthesia in Cystoscopic Procedures:A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07590544
- Acronym / sponsor ID
- PGHI-IRB(DME)-RCD-06-074
- Conditions
- Cystoscopy
- Keywords
- spinal anesthesia, hyperbaric bupivacaine, cystoscopy, hemodynamic stability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- PAEC General Hospital, IslamabadUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| 0.5% hyperbaric bupivacaine group | Active comparator | Drug: 0.5% Hyperbaric BupivicainePatients will receive spinal anesthesia with 0.5% hyperbaric bupivacainefor cystoscopic procedures.hemodynamic parameters will be monitored and compared with other group. |
| 0.75% hyperbaric bupivacaine group | Active comparator | Drug: 0.75% hyperbaric bupivacainePatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-80 years. American society of Anesthesiologist(ASA) physical status I-II. Sceduled for elective cystoscopic procedures under spinal anesthesia.
Key exclusion criteria (2 listed)
- Patient refusal. Contraindication to spinal anesthesia(e.g coagulopathy ,infection at injection site).
- Known hypersensitivity to bupivacaine. Significant cardiovascular,hepatic or renal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5% Hyperbaric Bupivicaine0.5% 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. | Drug | 0.5% hyperbaric bupivacaine group |
| 0.75% hyperbaric bupivacaine0.75% 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. | Drug | 0.75% hyperbaric bupivacaine group |
Primary outcome
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.
1 secondary outcome
Requirement for Vasopressors, Atropine ,and Intravenous fluids
Time frame: From institution of spinal block upto 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No. As the hospital where this study is being conducted does not allow to share any collected data with other researches due to patient confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Salbia Bibi, FCPS principal investigator
PAEC General Hospital, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.5% Hyperbaric Bupivicaine and 0.75% hyperbaric bupivacaine in people with Cystoscopy, run by PAEC General Hospital, Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Salbia Bibi, FCPS (+923330335004, dr.salbia@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of frequency and mean changes in systolic blood pressure and heart rate (time frame: From institution of spinal block upto 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.