Colo-rectal CancerPhase 3NCT05021263
Does IV Magnesium Improve Quality of Recovery With ERAS Protocols in Laparoscopic Colorectal Surgery?
A Phase 3 study testing IV Medications in people with Colo-rectal Cancer and Anesthesia, run by Thomas Jefferson University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer, Anesthesia
- What is being tested?
- IV Medications
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2022to 29 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective Laparoscopic Colorectal Surgery
- Age 18-75
- ASA (American Society of Anesthesiologists) Physical Status Classification 1-3
Who cannot join
- 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
Show all 11Show fewer
- Hepatic Cirrhosis
- Neuromuscular disease
- Heart block on EKG
- Uncontrolled diabetes with Hba1c > 8%
- Known allergies to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Colo-rectal Cancer, Anesthesia
- Being tested
- IV Medications, placebo
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV MedicationsDrug
IV magnesium sulfate, used to replete magnesium stores
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Group | Experimental | 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. Receives: Drug: IV Medications |
| Control Group | Placebo comparator | 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. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery 40 Questionnaire
Validated Assessment of Postoperative Recovery
Measured: Postoperative Day 0-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start27 May 2022
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Min, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021263
- Sponsor's protocol ID
- 21D.499
- Status last verified
- Apr 2024
- First submitted
- 16 Aug 2021
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does IV Magnesium Improve Quality of Recovery With ERAS Protocols in Laparoscopic Colorectal Surgery?
- ClinicalTrials.gov ID
- NCT05021263
- Acronym / sponsor ID
- 21D.499
- Conditions
- Colo-rectal Cancer, Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 27 May 2022 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Group | Experimental | Drug: IV MedicationsThe 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. |
| Control Group | Placebo comparator | Other: placeboThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective Laparoscopic Colorectal Surgery
- Age 18-75
- ASA (American Society of Anesthesiologists) Physical Status Classification 1-3
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV MedicationsIV magnesium sulfate, used to replete magnesium stores | Drug | Magnesium Group |
| placeboplacebo | Other | Control Group |
Primary outcome
Quality of Recovery 40 Questionnaire
Time frame: Postoperative Day 0-2
Validated Assessment of Postoperative Recovery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IV Medications in people with Colo-rectal Cancer and Anesthesia, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery 40 Questionnaire (time frame: Postoperative Day 0-2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.