Clinical trial NCT05049707: 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
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Brain Tumor
Surgery
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Quality of Recovery Questionnaire 40
timeFrame: Postoperative days 0-2
Secondary outcomes:
measure: Hypertension Postoperative
timeFrame: postoperative days 0-2
measure: Postoperative Hyperglycemia
timeFrame: Postoperative days 0-2
measure: Complications Possibly Related to Intraoperative Neuromonitoring
timeFrame: postoperative days 0-2
measure: Shivering
timeFrame: First 2 hours in the postoperative care unit or intensive care unit
Other outcomes:
Locations:
Study officials:
affiliation: Thomas Jefferson University
name: Kevin Min, MD
role: PRINCIPAL_INVESTIGATOR
References: