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

Phase 3

Completed

• Conditions: Colo-rectal Cancer; Anesthesia
• Interventions: Other: placebo; Drug: IV Medications

• Registration Number: NCT05021263
• Lead Sponsor: Thomas Jefferson University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-25
• Study Start: 2022-05-27
• Primary Completion: 2023-12-29
• Study Completion: 2023-12-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	placebo	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.
Magnesium Group	IV Medications	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.

Primary Outcome Measures

Name	Time	Method
Quality of Recovery 40 Questionnaire	Postoperative Day 0-2	Validated Assessment of Postoperative Recovery

Trial Locations

Locations (1)

Thomas Jefferson; 🇺🇸 Philadelphia, Pennsylvania, United States