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

NCT ID: NCT05049707

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-10-01

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.

Conditions

Brain Tumor; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

IV magnesium sulfate

Intervention Type: DRUG

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

Interventions

IV magnesium sulfate

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Magnesium Sulfate IV

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Kevin Min

Assistant Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin Min, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Central Contacts

Kevin J Min, MD

Role: CONTACT

kevin.min@jefferson.edu

631-485-2542

Other Identifiers

#21D.124

Identifier Type: -

Identifier Source: org_study_id