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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05021263
• Other study ID #: 21D.499
• Status: Completed
• Phase: Phase 3
• Start date: May 27, 2022
• Est. completion date: December 29, 2023

Study information

• Verified date: April 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 29, 2023
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Colo-rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• IV Medications
IV magnesium sulfate, used to replete magnesium stores

Other:
• placebo
placebo

Locations

Country	Name	City	State
United States	Thomas Jefferson	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Recovery 40 Questionnaire	Validated Assessment of Postoperative Recovery	Postoperative Day 0-2