Postinduction HypotensionPhase 4NCT06985654
The Effect of Preoperative Intravenous Fluid Bolus on Post-induction Hypotension in Elective Cystoscopies.
A Phase 4 study testing Lactated Ringers in people with Postinduction Hypotension and Hypotension During Surgery, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
This study aims to determine whether a standardized, weight-based crystalloid fluid bolus administered preoperatively reduces the incidence of postinduction hypotension (PIH) in patients undergoing cystoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postinduction Hypotension, Hypotension During Surgery
- What is being tested?
- Lactated Ringers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Undergoing elective cystoscopy surgery as the primary procedure.
- Able to provide informed consent.
Who cannot join
- Emergency surgeries.
- Past history of amputations of any body part.
- Allergies or contraindications to any medications used in the protocol or lactated ringers.
- Systolic heart failure with LVEF < 30% within the last year.
- Severely depressed RV function within the last year.
- Restrictive diastolic dysfunction within the last year.
- Currently pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to determine whether a standardized, weight-based crystalloid fluid bolus administered preoperatively reduces the incidence of postinduction hypotension (PIH) in patients undergoing cystoscopy.
- Being tested
- Lactated Ringers
- Keywords
- postinduction hypotension, hypotension, cystoscopy, lactated ringers
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated RingersDrug
A bolus of Lactated Ringers (15mL/kg of ideal body weight) will be given to patients prior to anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| No Treatment | No intervention | Patients will receive an ultrasound scan on their heart to determine cardiac output before surgery, but no fluid bolus will be given. |
| Preoperative Fluid Bolus | Experimental | Patients will receive an ultrasound scan on their heart to determine cardiac output and will also receive a fluid bolus of Lactated Ringers before surgery. Receives: Drug: Lactated Ringers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postinduction Hypotension
Number of patients that experience a decrease in mean arterial pressure (MAP) greater than 20% from the baseline MAP.
Measured: From the time patient enters the operating room to the end of surgery, assessed up to 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start14 Jul 2025
- Primary completionJun 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 Postinduction HypotensionStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sagar Bansal, University of Missouri-Columbia
- Investigators
- Sagar Bansal, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985654
- Sponsor's protocol ID
- 2126906
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Intravenous Fluid Bolus on Post-induction Hypotension in Elective Cystoscopies.
- ClinicalTrials.gov ID
- NCT06985654
- Acronym / sponsor ID
- 2126906
- Keywords
- postinduction hypotension, hypotension, cystoscopy, lactated ringers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 May 2025 (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.
This study aims to determine whether a standardized, weight-based crystalloid fluid bolus administered preoperatively reduces the incidence of postinduction hypotension (PIH) in patients undergoing cystoscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Treatment | No intervention | –Patients will receive an ultrasound scan on their heart to determine cardiac output before surgery, but no fluid bolus will be given. |
| Preoperative Fluid Bolus | Experimental | Drug: Lactated RingersPatients will receive an ultrasound scan on their heart to determine cardiac output and will also receive a fluid bolus of Lactated Ringers before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old.
- Undergoing elective cystoscopy surgery as the primary procedure.
- Able to provide informed consent.
Key exclusion criteria (7 listed)
- Emergency surgeries.
- Past history of amputations of any body part.
- Allergies or contraindications to any medications used in the protocol or lactated ringers.
- Systolic heart failure with LVEF < 30% within the last year.
- Severely depressed RV function within the last year.
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 |
|---|---|---|
| Lactated RingersA bolus of Lactated Ringers (15mL/kg of ideal body weight) will be given to patients prior to anesthesia induction. | Drug | Preoperative Fluid Bolus |
Primary outcome
Incidence of Postinduction Hypotension
Time frame: From the time patient enters the operating room to the end of surgery, assessed up to 24 hours.
Number of patients that experience a decrease in mean arterial pressure (MAP) greater than 20% from the baseline MAP.
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 18 Sep 2025.
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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.
Sagar Bansal, MD principal investigator
University of Missouri-Columbia
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 Lactated Ringers in people with Postinduction Hypotension and Hypotension During Surgery, run by University of Missouri-Columbia at 1 site in United States.
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 3 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 18 Sep 2025. 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postinduction Hypotension (time frame: From the time patient enters the operating room to the end of surgery, assessed up to 24 hours.). 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 18 Sep 2025.