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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01433081
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : February 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. Opioid Consumption [ Time Frame: 24 hours ]
    Opioid consumption after discharge

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01433081

United States, Illinois
Prentice Womens Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: Gildasio De Oliveira, MD Northwestern University

Responsible Party: Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University Identifier: NCT01433081     History of Changes
Other Study ID Numbers: STU00032878
First Posted: September 13, 2011    Key Record Dates
Results First Posted: April 2, 2014
Last Update Posted: April 2, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Magnesium Sulfate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents