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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01433081
Enrollment
50
Registered
2011-09-13
Start date
2011-02-28
Completion date
2013-04-30
Last updated
2014-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use, Unspecified, Uncomplicated, Pain

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.

Interventions

DRUGPlacebo infusion of .9 normal saline

administration of .9 normal saline

DRUGadministration of magnesium sulfate

administration of magnesium sulfate

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 64 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Recovery Scores Post Operative24 hours post operativeQuality of recovery scores post operative. Scored on a scale of 40 (poor recovery) to 200 (good recovery).

Secondary

MeasureTime frameDescription
Opioid Consumption24 hoursOpioid consumption after discharge

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

ArmCount
Magnesium Sulfate Infusion
Administration of magnesium suflate
25
Placebo
.9 normal saline infusion
25
Total50

Baseline characteristics

CharacteristicPlaceboMagnesium Sulfate InfusionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
25 Participants25 Participants50 Participants
Age, Continuous52 years
STANDARD_DEVIATION 7.7
53 years
STANDARD_DEVIATION 6.15
52 years
STANDARD_DEVIATION 7.01
Region of Enrollment
United States
25 participants25 participants50 participants
Sex: Female, Male
Female
25 Participants25 Participants50 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
7 / 2310 / 23
serious
Total, serious adverse events
0 / 230 / 23

Outcome results

Primary

Quality of Recovery Scores Post Operative

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

Time frame: 24 hours post operative

Population: Two drop outs for either arm were removed from analysis.

ArmMeasureValue (MEAN)
Magnesium Sulfate InfusionQuality of Recovery Scores Post Operative183 units on scale 40 (low) - 200 (high)
PlaceboQuality of Recovery Scores Post Operative159 units on scale 40 (low) - 200 (high)
Secondary

Opioid Consumption

Opioid consumption after discharge

Time frame: 24 hours

ArmMeasureValue (MEDIAN)
Magnesium Sulfate InfusionOpioid Consumption10 miligram morphine equivalents
PlaceboOpioid Consumption30 miligram morphine equivalents

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026