The Effect of Magnesium Sulfate Infusion on the Quality of Recovery of Ambulatory Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pain Opioid Use, Unspecified, Uncomplicated |
Drug: Placebo infusion of .9 normal saline Drug: administration of magnesium sulfate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | The Effect of Magnesium Sulfate Infusion on the Quality of Recovery of Ambulatory Patients |
- Quality of recovery scores post operatively [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: No ]Quality of recovery scores post operatively
- Opioid consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Opioid consumption
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Magnesium sulfate infusion
Administration of magnesium suflate
|
Drug: administration of magnesium sulfate
administration of magnesium sulfate
|
|
Placebo Comparator: Placebo
.9 normal saline infusion
|
Drug: Placebo infusion of .9 normal saline
administration of .9 normal saline
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- undergoing lumpectomy
- ASA I and II
- Age between 18-64
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Gildasio De Oliveira, MD | 312-926-8373 | |
| Contact: Robert McCarthy, PharmD | 312-926-9015 | r-mccarthy@northwestern.edu |
| United States, Illinois | |
| Prentice Womens Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Gildasio De Oliveira, MD 312-926-8373 | |
| Contact: Robert McCarthy, PharmD 312-926-9015 r-mccarthy@northwestern.edu | |
| Principal Investigator: Gildasio De Oliveira, MD | |
| Principal Investigator: | Gildasio De Oliveira, MD | Northwestern University |
More Information
Publications:
| Responsible Party: | Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01433081 History of Changes |
| Other Study ID Numbers: | STU00032878 |
| Study First Received: | September 9, 2011 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Magnesium Sulfate Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics |
Central Nervous System Depressants Anti-Arrhythmia Agents Cardiovascular Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Tocolytic Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 19, 2013