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

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01433081
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Opioid Use, Unspecified, Uncomplicated	Drug: Placebo infusion of .9 normal saline; Drug: administration of magnesium sulfate	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: The Effect of Magnesium Sulfate Infusion on the Quality of Recovery of Ambulatory Patients
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Quality of Recovery Scores Post Operative [24 hours post operative]

   Quality of recovery scores post operative. Scored on a scale of 40 (poor recovery) to 200 (good recovery).

Secondary Outcome Measures

1. Opioid Consumption [24 hours]

   Opioid consumption after discharge

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes 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

Locations

	Site	City	State	Country	Postal Code
1	Prentice Womens Hospital	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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

• Responsible Party: Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT01433081
• Other Study ID Numbers: STU00032878
• First Posted: Sep 13, 2011
• Last Update Posted: Apr 2, 2014
• Last Verified: Feb 1, 2014

• Additional relevant MeSH terms: Magnesium Sulfate

Study Results

Participant Flow

Recruitment Details	Patients were enrolled consecutively from 2/2011 through 4/2013.

Arm/Group Title	Magnesium Sulfate Infusion	Placebo
Arm/Group Description	Administration of magnesium suflate	Normal saline infusion
Period Title: Overall Study
STARTED	25	25
COMPLETED	23	23
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Magnesium Sulfate Infusion	Placebo	Total
Arm/Group Description	Administration of magnesium suflate	.9 normal saline infusion	Total of all reporting groups
Overall Participants	25	25	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	25 100%	25 100%	50 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53 (6.15)	52 (7.7)	52 (7.01)
Sex: Female, Male (Count of Participants)
Female	25 100%	25 100%	50 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	25 100%	25 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Quality of Recovery Scores Post Operative
Description	Quality of recovery scores post operative. Scored on a scale of 40 (poor recovery) to 200 (good recovery).
Time Frame	24 hours post operative

Outcome Measure Data

Analysis Population Description

Two drop outs for either arm were removed from analysis.

Arm/Group Title	Magnesium Sulfate Infusion	Placebo
Arm/Group Description	Administration of magnesium suflate	Normal saline infusion
Measure Participants	23	23
Mean (Inter-Quartile Range) [units on scale 40 (low) - 200 (high)]	183	159

2. Secondary Outcome

Title	Opioid Consumption
Description	Opioid consumption after discharge
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Magnesium Sulfate Infusion	Placebo
Arm/Group Description	Administration of magnesium suflate	.9 normal saline infusion
Measure Participants	23	23
Median (Inter-Quartile Range) [miligram morphine equivalents]	10	30

Adverse Events

Time Frame	24 hours
Adverse Event Reporting Description	Nausea in the post operative period
Arm/Group Title	Magnesium Sulfate Infusion		Placebo
Arm/Group Description	Administration of magnesium suflate		.9 normal saline infusion
All Cause Mortality
	Magnesium Sulfate Infusion		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Magnesium Sulfate Infusion		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Magnesium Sulfate Infusion		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/23 (30.4%)		10/23 (43.5%)
Gastrointestinal disorders
Nausea	7/23 (30.4%)	10	10/23 (43.5%)	10
Vomiting	2/23 (8.7%)	2	6/23 (26.1%)	6

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.