NCT06985654

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
6mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

May 1, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

July 14, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

September 18, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

May 1, 2025

Last Update Submit

September 17, 2025

Conditions

Keywords

postinduction hypotensionhypotensioncystoscopylactated ringers

Outcome Measures

Primary Outcomes (1)

  • Incidence of Postinduction Hypotension

    Number of patients that experience a decrease in mean arterial pressure (MAP) greater than 20% from the baseline MAP.

    From the time patient enters the operating room to the end of surgery, assessed up to 24 hours.

Other Outcomes (2)

  • Inferior Vena Cava Size

    From the time of consent to the beginning of surgery, assessed up to 24 hours.

  • Respiratory Variability

    From the time of consent to the beginning of surgery, assessed up to 24 hours.

Study Arms (2)

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.

Drug: Lactated Ringers

Interventions

A bolus of Lactated Ringers (15mL/kg of ideal body weight) will be given to patients prior to anesthesia induction.

Preoperative Fluid Bolus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old.
  • Undergoing elective cystoscopy surgery as the primary procedure.
  • Able to provide informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Hypotension

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Sagar Bansal, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

May 1, 2025

First Posted

May 22, 2025

Study Start

July 14, 2025

Primary Completion

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 18, 2025

Record last verified: 2025-05

Locations