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

NCT05021263 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 21D.499
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery 40 Questionnaire

  Validated Assessment of Postoperative Recovery

  Postoperative Day 0-2

Study Arms (2)

Magnesium Group

EXPERIMENTAL

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.

Drug: IV Medications

Control Group

PLACEBO COMPARATOR

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.

Other: placebo

Interventions

IV Medications DRUG

IV magnesium sulfate, used to replete magnesium stores

Magnesium Group

placebo OTHER

placebo

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 25, 2021
• Study Start: May 27, 2022
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

US (1)