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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium sulfate infusion | Active Comparator | Administration of magnesium suflate |
|
| Placebo | Placebo Comparator | .9 normal saline infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo infusion of .9 normal saline | Drug | administration of .9 normal saline |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery Scores Post Operative | Quality of recovery scores post operative. Scored on a scale of 40 (poor recovery) to 200 (good recovery). | 24 hours post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Opioid consumption after discharge | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gildasio De Oliveira, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prentice Womens Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12873949 | Background | 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. | |
| 18183534 | Background | White PF. Multimodal analgesia: its role in preventing postoperative pain. Curr Opin Investig Drugs. 2008 Jan;9(1):76-82. |
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Patients were enrolled consecutively from 2/2011 through 4/2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Magnesium Sulfate Infusion | Administration of magnesium suflate |
| FG001 | Placebo | Normal saline infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Magnesium Sulfate Infusion | Administration of magnesium suflate |
| BG001 | Placebo | .9 normal saline infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quality of Recovery Scores Post Operative | Quality of recovery scores post operative. Scored on a scale of 40 (poor recovery) to 200 (good recovery). | Two drop outs for either arm were removed from analysis. | Posted | Mean | Inter-Quartile Range | units on scale 40 (low) - 200 (high) | 24 hours post operative |
|
24 hours
Nausea in the post operative period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Magnesium Sulfate Infusion | Administration of magnesium suflate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 10.o | Systematic Assessment | Nausea in 24 hour post operative period. |
We only examined subjects with normal kidney function that were at low risk for magnesium toxicity. It is possible that the current intervention regimen could have led to toxic levels in higher risk patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gildasio De Oliveira MD | Northwestern University | 312-472-3573 | g-jr@northwestern.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| administration of magnesium sulfate |
| Drug |
administration of magnesium sulfate |
|
| 19923506 | Background | McKay 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. |
| 19702519 | Background | Berti 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. |
| 6325946 | Background | Mayer 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. |
| 11704642 | Background | Begon 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. |
| 18276652 | Background | Ryu 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. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Opioid Consumption | Opioid consumption after discharge | Posted | Median | Inter-Quartile Range | miligram morphine equivalents | 24 hours |
|
|
|
| 0 |
| 23 |
| 7 |
| 23 |
| EG001 | Placebo | .9 normal saline infusion | 0 | 23 | 10 | 23 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.o | Systematic Assessment | Vomiting in 24 hour period post operative. |
|
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