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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05049707
• Other study ID #: #21D.124
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 1, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: April 2023
• Source: Thomas Jefferson University
• Contact: Kevin J Min, MD
• Phone: 631-485-2542
• Email: kevin.min[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Surgery

Intervention

Drug:
• IV magnesium sulfate
15 grams magnesium in 500 cc normal saline delivered at a rate of 15 mg/kg/hr

Other:
• Placebo
500 cc normal saline delivered in equivalent rates as the treatment group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Recovery Questionnaire 40	Validated measure of postoperative quality of recovery	Postoperative days 0-2
Secondary	Hypertension Postoperative	systolic blood pressure > 160	postoperative days 0-2
Secondary	Postoperative Hyperglycemia	glucose > 180	Postoperative days 0-2
Secondary	Complications Possibly Related to Intraoperative Neuromonitoring	We will monitor for rates of complications postoperatively, noting whether or not they could have been detected by intraoperative neuromonitoring	postoperative days 0-2
Secondary	Shivering	Bedside Shivering Scale	First 2 hours in the postoperative care unit or intensive care unit