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OpenTrials
Completed

NCT Number: NCT05021263

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Thomas Jefferson

Philadelphia, Pennsylvania, 19102, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV Medications

Drug

IV magnesium sulfate, used to replete magnesium stores

Placebo

Other

placebo

Primary outcomes

  1. Quality of Recovery 40 Questionnaire

    Time frame: Postoperative Day 0-2

    Validated Assessment of Postoperative Recovery

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2021
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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