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

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ClinicalTrials.gov Identifier: NCT05049707
Recruitment Status : Not yet recruiting
First Posted : September 20, 2021
Last Update Posted : June 8, 2022
Sponsor:
Information provided by (Responsible Party):
Kevin Min, Thomas Jefferson University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Brain Tumor Surgery Drug: IV magnesium sulfate Other: Placebo Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Perioperative Intravenous Magnesium Affect Postoperative Quality of Recovery in Elective Craniotomy Surgery Patients?
Estimated Study Start Date : November 1, 2022
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control
The control arm will receive an equivalent volume of normal saline as the treatment group
 Other: Placebo
500 cc normal saline delivered in equivalent rates as the treatment group
Experimental: IV magnesium
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.
 Drug: IV magnesium sulfate
15 grams magnesium in 500 cc normal saline delivered at a rate of 15 mg/kg/hr
Other Name: Magnesium Sulfate IV


Outcome Measures
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Primary Outcome Measures :
  1. Quality of Recovery Questionnaire 40 [ Time Frame: Postoperative days 0-2 ]
    Validated measure of postoperative quality of recovery


Secondary Outcome Measures :
  1. Hypertension Postoperative [ Time Frame: postoperative days 0-2 ]
    systolic blood pressure > 160

  2. Postoperative Hyperglycemia [ Time Frame: Postoperative days 0-2 ]
    glucose > 180

  3. Complications Possibly Related to Intraoperative Neuromonitoring [ Time Frame: postoperative days 0-2 ]
    We will monitor for rates of complications postoperatively, noting whether or not they could have been detected by intraoperative neuromonitoring

  4. Shivering [ Time Frame: First 2 hours in the postoperative care unit or intensive care unit ]
    Bedside Shivering Scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05049707


Contacts
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Contact: Kevin J Min, MD 631-485-2542 kevin.min@jefferson.edu

Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Kevin Min, MD Thomas Jefferson University
More Information
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Responsible Party: Kevin Min, Assistant Professor of Anesthesiology, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT05049707    
Other Study ID Numbers: #21D.124
First Posted: September 20, 2021    Key Record Dates
Last Update Posted: June 8, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents