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Does Perioperative Intravenous Magnesium Affect Postoperative Quality of Recovery in Craniotomy Surgery Patients?

Primary Purpose

Brain Tumor, Surgery

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
IV magnesium sulfate
Placebo
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Brain Tumor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient age 18-85
  • ASA (American Society of Anesthesiologists) Physical Status Classification 1-3
  • Glasgow Coma Scale (GCS) of 15
  • Adequate english comprehension

Exclusion Criteria:

  • pregnant or nursing patients
  • patients with known allergies to any of the study drugs
  • patient's refusal
  • patients with a history of cirrhosis
  • chronic kidney disease stage 3 or higher
  • known history of substance abuse
  • history of neuromuscular disease
  • history of heart block

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Control

    IV magnesium

    Arm Description

    The control arm will receive an equivalent volume of normal saline as the treatment group

    We will randomize patients in the treatment group to receive either a 50 mg/kg bolus of intravenous magnesium preoperatively followed by a magnesium infusion of 15mg/kg/hr, to be given after intraoperative neuromonitoring staff have been able to record baseline neurological data.

    Outcomes

    Primary Outcome Measures

    Quality of Recovery Questionnaire 40
    Validated measure of postoperative quality of recovery

    Secondary Outcome Measures

    Hypertension Postoperative
    systolic blood pressure > 160
    Postoperative Hyperglycemia
    glucose > 180
    Complications Possibly Related to Intraoperative Neuromonitoring
    We will monitor for rates of complications postoperatively, noting whether or not they could have been detected by intraoperative neuromonitoring
    Shivering
    Bedside Shivering Scale

    Full Information

    First Posted
    August 31, 2021
    Last Updated
    April 10, 2023
    Sponsor
    Thomas Jefferson University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05049707
    Brief Title
    Does Perioperative Intravenous Magnesium Affect Postoperative Quality of Recovery in Craniotomy Surgery Patients?
    Official Title
    Does Perioperative Intravenous Magnesium Affect Postoperative Quality of Recovery in Elective Craniotomy Surgery Patients?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2024 (Anticipated)
    Primary Completion Date
    October 1, 2025 (Anticipated)
    Study Completion Date
    October 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Thomas Jefferson University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Perioperative pain management for craniotomy patients may be challenging because the commonly used agents such as opioids, gabapentin, and dexmedetomidine also cause sedation, which can confound the neurological exam and can lead to respiratory depression and increased intracranial pressure. Preoperative intravenous magnesium boluses and infusions have previously been established as an effective, nonsedating analgesic that can reduce opioid consumption 25-30% up to 48 hours postoperatively. However, intravenous magnesium has not seen widespread use in craniotomy patients due to concerns for interference with the neurological monitoring that commonly occurs in these cases. Intravenous magnesium given as a bolus preoperatively or as a constant infusion may avoid these problems and has never been investigated. The goal of this study is to compare intravenous magnesium given preoperatively and intraoperatively to placebo in adult elective craniotomy patients to improve quality of recovery postoperatively, and evaluate safety and tolerability. Secondary endpoints will include evaluating for pain, sedation, agitation, blood pressure, and opioid consumption postoperatively.
    Detailed Description
    The study is a prospective, randomized, controlled, and double-blinded clinical trial comparing clinical outcomes of craniotomy patients who a magnesium infusion of 15mg/kg/hr to a placebo group of patients who will receive a saline bolus and infusion of equivalent volume starting at surgical closure and continuing for 15 hours. The sample size calculations are based on an effect size 24 point increase in Quality of Recovery-40 Questionnaire scores from a previous randomized control trial featuring the same bolus and infusion regimen as this trial. Investigators, patients, and providers will be blinded. Patients over the age of 18 undergoing elective craniotomy surgery will be enrolled. The study population will consist of patients undergoing elective craniotomy surgery. The inclusion criteria consists of patient age 18-85, ASA (American Society of Anesthesiologists) Physical Status Classification 1-3, with Glasgow Coma Scale (GCS) of 15 with adequate english comprehension. Exclusion criteria includes pregnant or nursing patients, patients with known allergies to any of the study drugs, patient's refusal, patients with a history of cirrhosis, chronic kidney disease stage 3 or higher, known history of substance abuse, neuromuscular disease or heart block.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Tumor, Surgery

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    The control arm will receive an equivalent volume of normal saline as the treatment group
    Arm Title
    IV magnesium
    Arm Type
    Experimental
    Arm Description
    We will randomize patients in the treatment group to receive either a 50 mg/kg bolus of intravenous magnesium preoperatively followed by a magnesium infusion of 15mg/kg/hr, to be given after intraoperative neuromonitoring staff have been able to record baseline neurological data.
    Intervention Type
    Drug
    Intervention Name(s)
    IV magnesium sulfate
    Other Intervention Name(s)
    Magnesium Sulfate IV
    Intervention Description
    15 grams magnesium in 500 cc normal saline delivered at a rate of 15 mg/kg/hr
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    500 cc normal saline delivered in equivalent rates as the treatment group
    Primary Outcome Measure Information:
    Title
    Quality of Recovery Questionnaire 40
    Description
    Validated measure of postoperative quality of recovery
    Time Frame
    Postoperative days 0-2
    Secondary Outcome Measure Information:
    Title
    Hypertension Postoperative
    Description
    systolic blood pressure > 160
    Time Frame
    postoperative days 0-2
    Title
    Postoperative Hyperglycemia
    Description
    glucose > 180
    Time Frame
    Postoperative days 0-2
    Title
    Complications Possibly Related to Intraoperative Neuromonitoring
    Description
    We will monitor for rates of complications postoperatively, noting whether or not they could have been detected by intraoperative neuromonitoring
    Time Frame
    postoperative days 0-2
    Title
    Shivering
    Description
    Bedside Shivering Scale
    Time Frame
    First 2 hours in the postoperative care unit or intensive care unit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patient age 18-85 ASA (American Society of Anesthesiologists) Physical Status Classification 1-3 Glasgow Coma Scale (GCS) of 15 Adequate english comprehension Exclusion Criteria: pregnant or nursing patients patients with known allergies to any of the study drugs patient's refusal patients with a history of cirrhosis chronic kidney disease stage 3 or higher known history of substance abuse history of neuromuscular disease history of heart block
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kevin J Min, MD
    Phone
    631-485-2542
    Email
    kevin.min@jefferson.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kevin Min, MD
    Organizational Affiliation
    Thomas Jefferson University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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