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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05049707
Enrollment
110
Registered
2021-09-20
Start date
2024-11-01
Completion date
2025-10-01
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor, Surgery

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.

Interventions

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

OTHERPlacebo

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

Sponsors

Thomas Jefferson University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Recovery Questionnaire 40Postoperative days 0-2Validated measure of postoperative quality of recovery

Secondary

MeasureTime frameDescription
Hypertension Postoperativepostoperative days 0-2systolic blood pressure \> 160
Postoperative HyperglycemiaPostoperative days 0-2glucose \> 180
Complications Possibly Related to Intraoperative Neuromonitoringpostoperative days 0-2We will monitor for rates of complications postoperatively, noting whether or not they could have been detected by intraoperative neuromonitoring
ShiveringFirst 2 hours in the postoperative care unit or intensive care unitBedside Shivering Scale

Contacts

Primary ContactKevin J Min, MD
kevin.min@jefferson.edu631-485-2542

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026