PainNCT01433081
The Effect of Magnesium Sulfate Infusion on the Quality of Recovery of Ambulatory Patients
A study testing administration of magnesium sulfate in people with Pain and Opioid Use, Unspecified, Uncomplicated, run by Northwestern University at 1 site in United States.
Trial summary
A national survey has revealed that 80% of patients experienced pain after surgery and 86% of these patients had moderate, severe or extreme pain (1).Postoperative pain can extend recovery room stay after surgery and it is also a common cause of unanticipated admissions which have important economic… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Pain, Opioid Use, Unspecified, Uncomplicated
- What is being tested?
- administration of magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- undergoing lumpectomy
- ASA I and II
- Age between 18-64
Who cannot join
- pregnancy
- breastfeeding -history of EKG abnormalities-
- kidney disease including: End Stage Renal Disease and polycystic kidney disease
- unable to understand the informed consent
- use of opioid in the last week
- use of calcium channel blockers
- Drop-out: surgeon or patient request
Trial locations and contacts
1 site in 1 country.
About this study
A national survey has revealed that 80% of patients experienced pain after surgery and 86% of these patients had moderate, severe or extreme pain (1).Postoperative pain can extend recovery room stay after surgery and it is also a common cause of unanticipated admissions which have important economic implications(2).More importantly, postoperative pain can lead to a poor quality of recovery in ambulatory patients. The Intraoperative use of medications that might decrease postoperative pain is therefore highly desirable.
Some medications such as lidocaine and ketamine have been proved to decrease postoperative pain when given during the Intraoperative period in ambulatory patients(3,4) but it is still unknown if those medications can in fact lead to a better quality of recovery .
Read more
Magnesium sulfate is a non-competitive calcium antagonist at the N-methyl-D- aspartate (NMDA) receptor(5). NMDA receptors have an important role on pain modulation (6). The use of Intraoperative magnesium in order to decrease postoperative pain had contradictory results in different studies. Some studies have shown a potential benefit of magnesium in decreasing postoperative pain (7,8) while others have not demonstrated any benefit (9,10).
In the ambulatory setting, specifically, Tramer et al. did not find any improvement on postoperative pain after an Intraoperative dose of magnesium for patients undergoing ilioinguinal hernia repair(11). Koinig et al., however, demonstrated a significant reduction in the postoperative analgesic requirements in patients undergoing arthroscopic knee surgery (12).
Even though, the reduction of postoperative opioid requirement has been used in many studies in the ambulatory literature, it has been recently questioned by some investigators (13).Patients might take more opioid medications but they may not necessarily develop opioid related side effects such as nausea and vomiting. A more global evaluation of the patient involving several aspects of recovery would be more significant.
The modified quality of recovery 40(MQOR40) is a validated 40 item instrument to assess the quality of postoperative recovery (14). Myles et al. concluded that the MQOR40 would be a useful outcome measure to assess the impact on changes in health care delivery (15), but anesthesia studies underutilize this instrument.
As more complex and painful procedures are being done in the ambulatory setting , the use of non-opioid strategies to control postoperative pain and to enhance quality of recovery will have even a greater role in the anesthetic management of patients. Magnesium has not been established as a potential adjuvant in ambulatory patients with conflicting results of previous investigators. The main objective of this study is to evaluate if the Intraoperative use of magnesium have the ability to improve postoperative quality of recovery in ambulatory patients.
- Conditions
- Pain, Opioid Use, Unspecified, Uncomplicated
- Being tested
- Placebo infusion of .9 normal saline, administration of magnesium sulfate
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo infusion of .9 normal salineDrug
administration of .9 normal saline
administration of magnesium sulfateDrug
administration of magnesium sulfate
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulfate infusion | Active comparator | Administration of magnesium suflate Receives: Drug: administration of magnesium sulfate |
| Placebo | Placebo comparator | .9 normal saline infusion Receives: Drug: Placebo infusion of .9 normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery Scores Post Operative
Quality of recovery scores post operative. Scored on a scale of 40 (poor recovery) to 200 (good recovery).
Measured: 24 hours post operative
Secondary outcomes (1)
Opioid Consumption
Opioid consumption after discharge
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Northwestern 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gildasio De Oliveira, Northwestern University
- Investigators
- Gildasio De Oliveira, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433081
- Sponsor's protocol ID
- STU00032878
- Status last verified
- Feb 2014
- First submitted
- 9 Sep 2011
- Last updated
- 2 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
PubMed 12873949White PF. Multimodal analgesia: its role in preventing postoperative pain. Curr Opin Investig Drugs. 2008 Jan;9(1):76-82.
PubMed 18183534McKay A, Gottschalk A, Ploppa A, Durieux ME, Groves DS. Systemic lidocaine decreased the perioperative opioid analgesic requirements but failed to reduce discharge time after ambulatory surgery. Anesth Analg. 2009 Dec;109(6):1805-8. doi: 10.1213/ANE.0b013e3181be371b.
PubMed 19923506Berti M, Baciarello M, Troglio R, Fanelli G. Clinical uses of low-dose ketamine in patients undergoing surgery. Curr Drug Targets. 2009 Aug;10(8):707-15. doi: 10.2174/138945009788982496.
PubMed 19702519Mayer ML, Westbrook GL, Guthrie PB. Voltage-dependent block by Mg2+ of NMDA responses in spinal cord neurones. Nature. 1984 May 17-23;309(5965):261-3. doi: 10.1038/309261a0.
PubMed 6325946Begon S, Pickering G, Eschalier A, Mazur A, Rayssiguier Y, Dubray C. Role of spinal NMDA receptors, protein kinase C and nitric oxide synthase in the hyperalgesia induced by magnesium deficiency in rats. Br J Pharmacol. 2001 Nov;134(6):1227-36. doi: 10.1038/sj.bjp.0704354.
PubMed 11704642Ryu JH, Kang MH, Park KS, Do SH. Effects of magnesium sulphate on intraoperative anaesthetic requirements and postoperative analgesia in gynaecology patients receiving total intravenous anaesthesia. Br J Anaesth. 2008 Mar;100(3):397-403. doi: 10.1093/bja/aem407.
PubMed 18276652
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Magnesium Sulfate Infusion on the Quality of Recovery of Ambulatory Patients
- ClinicalTrials.gov ID
- NCT01433081
- Acronym / sponsor ID
- STU00032878
- Conditions
- Pain, Opioid Use, Unspecified, Uncomplicated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 13 Sep 2011 (estimated)
- Results
- Posted 2 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A national survey has revealed that 80% of patients experienced pain after surgery and 86% of these patients had moderate, severe or extreme pain (1).Postoperative pain can extend recovery room stay after surgery and it is also a common cause of unanticipated admissions which have important economic implications(2).More importantly, postoperative pain can lead to a poor quality of recovery in ambulatory patients. The Intraoperative use of medications that might decrease postoperative pain is therefore highly desirable.
Some medications such as lidocaine and ketamine have been proved to decrease postoperative pain when given during the Intraoperative period in ambulatory patients(3,4) but it is still unknown if those medications can in fact lead to a better quality of recovery .
Magnesium sulfate is a non-competitive calcium antagonist at the N-methyl-D- aspartate (NMDA) receptor(5). NMDA receptors have an important role on pain modulation (6). The use of Intraoperative magnesium in order to decrease postoperative pain had contradictory results in different studies. Some studies have shown a potential benefit of magnesium in decreasing postoperative pain (7,8) while others have not demonstrated any benefit (9,10).
In the ambulatory setting, specifically, Tramer et al. did not find any improvement on postoperative pain after an Intraoperative dose of magnesium for patients undergoing ilioinguinal hernia repair(11). Koinig et al., however, demonstrated a significant reduction in the postoperative analgesic requirements in patients undergoing arthroscopic knee surgery (12).
Even though, the reduction of postoperative opioid requirement has been used in many studies in the ambulatory literature, it has been recently questioned by some investigators (13).Patients might take more opioid medications but they may not necessarily develop opioid related side effects such as nausea and vomiting. A more global evaluation of the patient involving several aspects of recovery would be more significant.
The modified quality of recovery 40(MQOR40) is a validated 40 item instrument to assess the quality of postoperative recovery (14). Myles et al. concluded that the MQOR40 would be a useful outcome measure to assess the impact on changes in health care delivery (15), but anesthesia studies underutilize this instrument.
As more complex and painful procedures are being done in the ambulatory setting , the use of non-opioid strategies to control postoperative pain and to enhance quality of recovery will have even a greater role in the anesthetic management of patients. Magnesium has not been established as a potential adjuvant in ambulatory patients with conflicting results of previous investigators. The main objective of this study is to evaluate if the Intraoperative use of magnesium have the ability to improve postoperative quality of recovery in ambulatory patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulfate infusion | Active comparator | Drug: administration of magnesium sulfateAdministration of magnesium suflate |
| Placebo | Placebo comparator | Drug: Placebo infusion of .9 normal saline.9 normal saline infusion |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- undergoing lumpectomy
- ASA I and II
- Age between 18-64
Key exclusion criteria (7 listed)
- pregnancy
- breastfeeding -history of EKG abnormalities-
- kidney disease including: End Stage Renal Disease and polycystic kidney disease
- unable to understand the informed consent
- use of opioid in the last week
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 |
|---|---|---|
| Placebo infusion of .9 normal salineadministration of .9 normal saline | Drug | Placebo |
| administration of magnesium sulfateadministration of magnesium sulfate | Drug | Magnesium sulfate infusion |
Primary outcome
Quality of Recovery Scores Post Operative
Time frame: 24 hours post operative
Quality of recovery scores post operative. Scored on a scale of 40 (poor recovery) to 200 (good recovery).
1 secondary outcome
Opioid Consumption
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12873949Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
- Background: PubMed 18183534White PF. Multimodal analgesia: its role in preventing postoperative pain. Curr Opin Investig Drugs. 2008 Jan;9(1):76-82.
- Background: PubMed 19923506McKay A, Gottschalk A, Ploppa A, Durieux ME, Groves DS. Systemic lidocaine decreased the perioperative opioid analgesic requirements but failed to reduce discharge time after ambulatory surgery. Anesth Analg. 2009 Dec;109(6):1805-8. doi: 10.1213/ANE.0b013e3181be371b.
- Background: PubMed 19702519Berti M, Baciarello M, Troglio R, Fanelli G. Clinical uses of low-dose ketamine in patients undergoing surgery. Curr Drug Targets. 2009 Aug;10(8):707-15. doi: 10.2174/138945009788982496.
- Background: PubMed 6325946Mayer ML, Westbrook GL, Guthrie PB. Voltage-dependent block by Mg2+ of NMDA responses in spinal cord neurones. Nature. 1984 May 17-23;309(5965):261-3. doi: 10.1038/309261a0.
- Background: PubMed 11704642Begon S, Pickering G, Eschalier A, Mazur A, Rayssiguier Y, Dubray C. Role of spinal NMDA receptors, protein kinase C and nitric oxide synthase in the hyperalgesia induced by magnesium deficiency in rats. Br J Pharmacol. 2001 Nov;134(6):1227-36. doi: 10.1038/sj.bjp.0704354.
- Background: PubMed 18276652Ryu JH, Kang MH, Park KS, Do SH. Effects of magnesium sulphate on intraoperative anaesthetic requirements and postoperative analgesia in gynaecology patients receiving total intravenous anaesthesia. Br J Anaesth. 2008 Mar;100(3):397-403. doi: 10.1093/bja/aem407.
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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.
Gildasio De Oliveira, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing administration of magnesium sulfate in people with Pain and Opioid Use, Unspecified, Uncomplicated, run by Northwestern 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 7 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 2 Apr 2014. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Scores Post Operative (time frame: 24 hours post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01433081, which also lists 7 linked publications.
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 2 Apr 2014.