NCT05021263CompletedPhase 3
Does IV Magnesium Improve Quality of Recovery With ERAS Protocols in Laparoscopic Colorectal Surgery?
Source: ClinicalTrials.gov · Last updated 9 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 16 Aug 2021
- Start date
- 27 May 2022
- Primary completion date
- 29 Dec 2023
- Lead sponsor
- Thomas Jefferson University
- Diseases
- Colorectal cancer
- NCT number
- NCT05021263
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 90
- From 27 May 2022 to the primary completion date, 29 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known history of substance abuse
- Chronic Kidney Disease (CKD) Stage 3
- Neuromuscular disease
- Heart block on EKG
- Known allergies to study drugs
Lab values
- Uncontrolled diabetes with Hba1c \> 8%
Other
- Current use of Buprenorphine/Suboxone or Methadone maintenance treatment
- Use of intra- and/or postoperative Ketamine or Lidocaine infusion
- Pre- or postoperative placement of Epidural catheter
- Inability to speak English or communicate verbally
- Hepatic Cirrhosis
Who the study is looking for
- Elective Laparoscopic Colorectal Surgery
- Age 18-75
- ASA (American Society of Anesthesiologists) Physical Status Classification 1-3
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thomas Jefferson Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.