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

Primary Purpose

Colo-rectal Cancer, Anesthesia

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IV Medications
placebo
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colo-rectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Thomas JeffersonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Magnesium Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Quality of Recovery 40 Questionnaire
Validated Assessment of Postoperative Recovery

Secondary Outcome Measures

Full Information

First Posted
August 16, 2021
Last Updated
June 3, 2022
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT05021263
Brief Title
Does IV Magnesium Improve Quality of Recovery With ERAS Protocols in Laparoscopic Colorectal Surgery?
Official Title
Does IV Magnesium Improve Quality of Recovery With ERAS Protocols in Laparoscopic Colorectal Surgery?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colo-rectal Cancer, Anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnesium Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IV Medications
Intervention Description
IV magnesium sulfate, used to replete magnesium stores
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Quality of Recovery 40 Questionnaire
Description
Validated Assessment of Postoperative Recovery
Time Frame
Postoperative Day 0-2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Min, MD
Phone
6314852542
Email
kevin.min@jefferson.edu
Facility Information:
Facility Name
Thomas Jefferson
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Min

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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