Does IV Magnesium Improve Quality of Recovery With ERAS Protocols in Laparoscopic Colorectal Surgery?

Completed · Phase 3 · Has a placebo group

Conditions studied: Colo-rectal Cancer, Anesthesia

In brief

This study is a randomized, double blind controlled trial examining the impact of incorporating a single intraoperative intravenous magnesium bolus and infusion into a preexisting Enhanced Recovery After Surgery (ERAS) protocol for colorectal surgery in place of preoperative oral pregabalin. These protocols are pathways designed with the goal of achieving early surgical recovery by utilizing a constellation of perioperative care techniques that include the use of opioid-sparing pain medications, minimally invasive approaches, and prevention of post-operative nausea and vomiting, among others. Intravenous magnesium has shown to be an effective non-opioid analgesic in abdominal surgeries that decreases total opioid consumption, pain, and improves recovery. The purpose of this study is to evaluate whether or not the addition of intravenous magnesium to our institutional ERAS protocol will improve specific outcome measures, and provide additional benefits when compared to oral preoperative pregabalin. The primary outcome is the patient's quality of recovery based on the "Quality of Recovery - 40 Questionnaire" (QOR 40), and secondary outcomes will be opioid consumption, pain, shivering, sedation scores, acute kidney injury, gastrointestinal function, respiratory function, and hospital length of stay.

Key facts

Study ID

NCT05021263

Run by

Thomas Jefferson University

People needed

90

Starts

2022-05-27

Expected to finish

2023-12-29

Last updated by the study team

2024-04-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Elective Laparoscopic Colorectal Surgery
• Age 18-75
• ASA (American Society of Anesthesiologists) Physical Status Classification 1-3

You may not qualify if…

• Current use of Buprenorphine/Suboxone or Methadone maintenance treatment
• Known history of substance abuse
• Use of intra- and/or postoperative Ketamine or Lidocaine infusion
• Pre- or postoperative placement of Epidural catheter
• Inability to speak English or communicate verbally
• Chronic Kidney Disease (CKD) Stage 3
• Hepatic Cirrhosis
• Neuromuscular disease
• Heart block on EKG
• Uncontrolled diabetes with Hba1c > 8%
• Known allergies to study drugs

Where it is running

• Thomas Jefferson — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.