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

NCT ID: NCT01433081

Last Updated: 2014-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-04-30

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.

Conditions

Pain; Opioid Use, Unspecified, Uncomplicated

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Magnesium sulfate infusion

Administration of magnesium suflate

Group Type: ACTIVE_COMPARATOR

administration of magnesium sulfate

Intervention Type: DRUG

administration of magnesium sulfate

Placebo

.9 normal saline infusion

Group Type: PLACEBO_COMPARATOR

Placebo infusion of .9 normal saline

Intervention Type: DRUG

administration of .9 normal saline

Interventions

Placebo infusion of .9 normal saline

administration of .9 normal saline

Intervention Type: DRUG

administration of magnesium sulfate

administration of magnesium sulfate

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Gildasio De Oliveira

Gildasio De Oliveira, M.D. Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gildasio De Oliveira, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Prentice Womens Hospital

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12873949 (View on PubMed)

White PF. Multimodal analgesia: its role in preventing postoperative pain. Curr Opin Investig Drugs. 2008 Jan;9(1):76-82.

Reference Type: BACKGROUND

PMID: 18183534 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19923506 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19702519 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6325946 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11704642 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18276652 (View on PubMed)

Other Identifiers

STU00032878

Identifier Type: -

Identifier Source: org_study_id