The Effect of Magnesium Sulfate Infusion on the Quality of Recovery of Ambulatory Patients

• ClinicalTrials.gov Identifier: NCT01433081
• Recruitment Status: Completed
• First Posted: September 13, 2011
• Results First Posted: April 2, 2014
• Last Update Posted: April 2, 2014
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Gildasio De Oliveira, Northwestern University

Tracking Information

• First Submitted Date: September 9, 2011
• First Posted Date: September 13, 2011
• Results First Submitted Date: November 13, 2013
• Results First Posted Date: April 2, 2014
• Last Update Posted Date: April 2, 2014
• Study Start Date: February 2011
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 19, 2014)

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).

Original Primary Outcome Measures (submitted: September 12, 2011)

Quality of recovery scores post operatively [ Time Frame: 24 hours post operatively ]

Quality of recovery scores post operatively

Current Secondary Outcome Measures (submitted: February 19, 2014)

Opioid Consumption [ Time Frame: 24 hours ]

Opioid consumption after discharge

Original Secondary Outcome Measures (submitted: September 12, 2011)

Opioid Consumption [ Time Frame: 24 hours ]

Opioid consumption

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Magnesium Sulfate Infusion on the Quality of Recovery of Ambulatory Patients
• Official Title: The Effect of Magnesium Sulfate Infusion on the Quality of Recovery of Ambulatory Patients

Brief 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 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention

Condition

• Pain
• Opioid Use, Unspecified, Uncomplicated

Intervention

• Drug: Placebo infusion of .9 normal saline
  administration of .9 normal saline
• Drug: administration of magnesium sulfate
  administration of magnesium sulfate

Study Arms

• Active Comparator: Magnesium sulfate infusion
  Administration of magnesium suflate
  Intervention: Drug: administration of magnesium sulfate
• Placebo Comparator: Placebo
  .9 normal saline infusion
  Intervention: Drug: Placebo infusion of .9 normal saline

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):534-40, table of contents.
• White PF. Multimodal analgesia: its role in preventing postoperative pain. Curr Opin Investig Drugs. 2008 Jan;9(1):76-82. Review.
• 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.
• 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. Review.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 12, 2011): 50
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2013
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01433081
• Other Study ID Numbers: STU00032878
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Gildasio De Oliveira, Northwestern University
• Study Sponsor: Northwestern University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gildasio De Oliveira, MD; Northwestern University

• PRS Account: Northwestern University
• Verification Date: February 2014