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

NCT05049707 | Unknown Phase 3 DMC

• 1 other identifier: #21D.124
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Brain Tumor; Surgery

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery Questionnaire 40

  Validated measure of postoperative quality of recovery

  Postoperative days 0-2

Secondary Outcomes (4)

• Hypertension Postoperative

  postoperative days 0-2

• Postoperative Hyperglycemia

  Postoperative days 0-2

• Complications Possibly Related to Intraoperative Neuromonitoring

  postoperative days 0-2

• Shivering

  First 2 hours in the postoperative care unit or intensive care unit

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Other: Placebo

IV magnesium

EXPERIMENTAL

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

Interventions

IV magnesium sulfate DRUG

15 grams magnesium in 500 cc normal saline delivered at a rate of 15 mg/kg/hr

Also known as: Magnesium Sulfate IV

IV magnesium

Placebo OTHER

500 cc normal saline delivered in equivalent rates as the treatment group

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Kevin Min, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin J Min, MD

CONTACT

631-485-2542; kevin.min@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 20, 2021
• Study Start: November 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share