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

NCT ID: NCT05021263

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-27
• Study Completion Date: 2023-12-29

Brief Summary

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.

Conditions

Colo-rectal Cancer; Anesthesia

Study Design

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

Study Groups

Magnesium Group

The magnesium group (Mg) will receive a bolus of 50 mg/kg of IV magnesium prior to incision and an infusion of 15 mg/kg/hr, with no preoperative oral pregabalin. All groups will receive preoperative oral acetaminophen, preoperative NSAIDs, subcutaneous heparin, intraoperative TAP block, intraoperative dexamethasone, ondansetron, transdermal scopolamine patch, and postoperative care as per the current ERAS protocol.

Group Type: EXPERIMENTAL

IV Medications

Intervention Type: DRUG

IV magnesium sulfate, used to replete magnesium stores

Control Group

The control group (Ct) will receive saline solution and no IV magnesium or oral pregabalin. All groups will receive preoperative oral acetaminophen, preoperative NSAIDs, subcutaneous heparin, intraoperative TAP block, intraoperative dexamethasone, ondansetron, transdermal scopolamine patch, and postoperative care as per the current ERAS protocol.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

placebo

Interventions

IV Medications

IV magnesium sulfate, used to replete magnesium stores

Intervention Type: DRUG

placebo

placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Kevin Min

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Thomas Jefferson

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

21D.499

Identifier Type: -

Identifier Source: org_study_id