Trial Outcomes & Findings for The Effect of Magnesium Sulfate Infusion on the Quality of Recovery of Ambulatory Patients (NCT NCT01433081)

NCT ID: NCT01433081

Last Updated: 2014-04-02

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 24 hours post operative
• Results posted on: 2014-04-02

Participant Flow

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

Participant milestones

Measure	Magnesium Sulfate Infusion Administration of magnesium suflate	Placebo Normal saline infusion
Overall Study STARTED	25	25
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Magnesium Sulfate Infusion n=25 Participants Administration of magnesium suflate	Placebo n=25 Participants .9 normal saline infusion	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	53 years STANDARD_DEVIATION 6.15 • n=5 Participants	52 years STANDARD_DEVIATION 7.7 • n=7 Participants	52 years STANDARD_DEVIATION 7.01 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours post operative

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

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

Outcome measures

Measure	Magnesium Sulfate Infusion n=23 Participants Administration of magnesium suflate	Placebo n=23 Participants Normal saline infusion
Quality of Recovery Scores Post Operative	183 units on scale 40 (low) - 200 (high) Interval 173.0 to 188.0	159 units on scale 40 (low) - 200 (high) Interval 153.0 to 175.0

SECONDARY outcome

Timeframe: 24 hours

Opioid consumption after discharge

Outcome measures

Measure	Magnesium Sulfate Infusion n=23 Participants Administration of magnesium suflate	Placebo n=23 Participants Normal saline infusion
Opioid Consumption	10 miligram morphine equivalents Interval 0.0 to 20.0	30 miligram morphine equivalents Interval 20.0 to 40.0

Adverse Events

Magnesium Sulfate Infusion

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Magnesium Sulfate Infusion n=23 participants at risk Administration of magnesium suflate	Placebo n=23 participants at risk .9 normal saline infusion
Gastrointestinal disorders Nausea	30.4% 7/23 • Number of events 10 • 24 hours Nausea in the post operative period	43.5% 10/23 • Number of events 10 • 24 hours Nausea in the post operative period
Gastrointestinal disorders Vomiting	8.7% 2/23 • Number of events 2 • 24 hours Nausea in the post operative period	26.1% 6/23 • Number of events 6 • 24 hours Nausea in the post operative period

Additional Information

Gildasio De Oliveira MD

Northwestern University

Phone: 312-472-3573

Email: g-jr@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place