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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05021263
Other study ID # 21D.499
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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