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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01433081
First received: September 9, 2011
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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 Intervention
Pain
Opioid Use, Unspecified, Uncomplicated
Drug: Placebo infusion of .9 normal saline
Drug: administration of magnesium sulfate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Magnesium Sulfate Infusion on the Quality of Recovery of Ambulatory Patients

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Quality of Recovery Scores Post Operative [ Time Frame: 24 hours post operative ] [ Designated as safety issue: No ]
    Quality of recovery scores post operative. Scored on a scale of 40 (poor recovery) to 200 (good recovery).


Secondary Outcome Measures:
  • Opioid Consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Opioid consumption after discharge


Enrollment: 50
Study Start Date: February 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01433081

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

Publications:
Responsible Party: Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01433081     History of Changes
Other Study ID Numbers: STU00032878
Study First Received: September 9, 2011
Results First Received: November 13, 2013
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014