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
About this trial
This is an interventional prevention trial for Brain Tumor
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
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
NCT ID
NCT05049707
First Posted
August 31, 2021
Last Updated
April 10, 2023
Sponsor
Thomas Jefferson University
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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Does Perioperative Intravenous Magnesium Affect Postoperative Quality of Recovery in Craniotomy Surgery Patients?
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