Effect of Treatment of Pre-induction Hypertension on Hemodynamic Stability During Induction of General Anesthesia

NCT06063772 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 807353
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if treatment of pre-induction hypertension with an intravenous short acting calcium channel antagonist will (1) reduce the magnitude and duration of blood pressure excursions outside of a pre-established normal range and (2) decrease the requirement for vasoactive medications during the period from induction of anesthesia until just prior to surgical incision.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Magnitude and Duration of Deviation from a normal blood pressure range.

  Blood pressure (systolic, diastolic and mean) will be recorded and plotted against time. The area under the curve of that plot that is outside of the normal blood pressure range is the outcome measure upon which the investigators will compare the clevidipine treated cohort to the placebo treated cohort.

  The investigators will measure and record blood pressure at 2 minute intervals from induction of anesthesia until just prior to incision.

Secondary Outcomes (1)

• Dose of vasoactive drugs used during induction of anesthesia.

  Investigators will record the dose of vasoactive drugs administered from induction until just prior to incision.

Study Arms (2)

Clevidipine

EXPERIMENTAL

Once consented, patients will be randomized into one of two groups using a block randomization table. The treatment arm will receive clevidipine. Clevidipine comes from the manufacturer in a "ready to use" formulation. It requires no preparation by pharmacy, nursing or physician staff. All patients randomized to receive clevidipine will be in the experimental cohort.

Drug: Clevidipine

Placebo (Lactated Ringers)

PLACEBO COMPARATOR

The Control arm will receive Lactate Ringers as placebo. All patients randomized to receive lactated ringers will be in the control cohort. Lactated Ringers is stored at room temperature (25°C)

Drug: Lactated Ringers, Intravenous

Interventions

Clevidipine DRUG

The investigator will start the appropriate drug and titrate the drug in the pre-operative area until the mean arterial pressure is between 70 mmHg and 110 mmHg. The infusion will be titrated every 90 seconds to a maximum rate 32 mg/hr for clevidipine or the volume equivalent of placebo.

Also known as: Cleviprex

Clevidipine

Lactated Ringers, Intravenous DRUG

The investigator will start the appropriate drug and titrate the drug in the pre-operative area until the mean arterial pressure is between 70 mmHg and 110 mmHg. The infusion will be titrated every 90s to a maximum rate 32mg/hr for clevidipine or the volume equivalent of placebo.

Also known as: Placebo

Placebo (Lactated Ringers)

Eligibility Criteria

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

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Any patient older than 18 years
• Scheduled for elective surgery requiring general anesthesia
• Presenting with hypertension during the pre-operative assessment (defined as either a systolic blood pressure \> 140 mmHg or a diastolic blood pressure \> 90 mmHg

You may not qualify if:

• Known adverse reaction to clevidipine or any of its constituent parts.
• Presence of structural heart disease.
• Known acute or chronic kidney disease.
• Pregnancy or lactation.
• Non-elective surgery.
• Treatment with another investigational drug or other intervention at the time of enrollment.
• Patients unable to consent for themselves.
• Incarcerated patients.
• Known defect in lipid metabolism.

Sponsors & Collaborators

• University of California, San Diego: lead

MeSH Terms

Conditions

Hypertension

Interventions

clevidipine; Ringer's Lactate

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Edward O O'Brien, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward O O'Brien, M.D.

CONTACT

619-543-5297; e1obrien@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 1. Initial identification of patients will be based on measured blood pressure. No other criteria will be used to identify patients for screening. 2. Cohort assignment will be made using a block randomization table. 3. The investigator measuring hemodynamics in the OR during induction will be blind to the patient's cohort assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Anesthesiology

Model Details: Prospective blinded trial comparing the effect on post induction hemodynamic stability of pre-induction treatment of hypertension to placebo.

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: October 3, 2023
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share