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

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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:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University

Tracking Information
First Submitted Date  ICMJE September 9, 2011
First Posted Date  ICMJE September 13, 2011
Results First Submitted Date  ICMJE November 13, 2013
Results First Posted Date  ICMJE April 2, 2014
Last Update Posted Date April 2, 2014
Study Start Date  ICMJE February 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: September 12, 2011)
Quality of recovery scores post operatively [ Time Frame: 24 hours post operatively ]
Quality of recovery scores post operatively
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2014)
Opioid Consumption [ Time Frame: 24 hours ]
Opioid consumption after discharge
Original Secondary Outcome Measures  ICMJE
 (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  ICMJE The Effect of Magnesium Sulfate Infusion on the Quality of Recovery of Ambulatory Patients
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Pain
  • Opioid Use, Unspecified, Uncomplicated
Intervention  ICMJE
  • Drug: Placebo infusion of .9 normal saline
    administration of .9 normal saline
  • Drug: administration of magnesium sulfate
    administration of magnesium sulfate
Study Arms  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2011)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01433081
Other Study ID Numbers  ICMJE STU00032878
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gildasio De Oliveira, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gildasio De Oliveira, MD Northwestern University
PRS Account Northwestern University
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP