Back to resultsThe Effect of Intraoperative Magnesium Sulfate Infusion on the Postoperative Recovery
Primary Purpose
Postoperative Pain
Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Magnesium Sulfate
Normal saline
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- aged between 18-65 year-old-patient (ASA I-II) who are planned to undergoing day surgery
Exclusion Criteria:
- ASA class ≥ III
- suspected imbalance of electrolyte
- myocardial damage or conduction delay
- myasthenia gravis or other neuromuscular disease
- impaired renal function
- already using any type of analgesia
- denial of participating in the study or not giving the informed consent
Sites / Locations
- Seoul National University Bundang Hospital, department of Anesthesia and pain
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Normal saline group
Magnesium group
Arm Description
after loading normal saline 100cc in 10-20 minutes, continuous infusion of normal saline until the end of surgery
after loading magnesium sulfate dosing 50 mg/kg (100cc) in 10-20 minutes, continuous infusion of magnesium sulfate 15 mg/kg/h until the end of surgery
Outcomes
Primary Outcome Measures
severity of postoperative pain
checking the postoperative pain in score at the recovery room and outpatient surgery center
Secondary Outcome Measures
Full Information
NCT ID
NCT03206008
First Posted
June 30, 2017
Last Updated
April 19, 2018
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03206008
Brief Title
The Effect of Intraoperative Magnesium Sulfate Infusion on the Postoperative Recovery
Official Title
The Effect of Intraoperative Magnesium Sulfate Infusion on the Postoperative Recovery After Outpatient Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
hard to get an informed concent because of small number of indiaiton of surgery
Study Start Date
November 18, 2016 (Actual)
Primary Completion Date
November 24, 2017 (Actual)
Study Completion Date
November 24, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Evaluating analgesic effect of intraoperative magnesium sulfate infusion in the outpatient surgery case
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal saline group
Arm Type
Placebo Comparator
Arm Description
after loading normal saline 100cc in 10-20 minutes, continuous infusion of normal saline until the end of surgery
Arm Title
Magnesium group
Arm Type
Active Comparator
Arm Description
after loading magnesium sulfate dosing 50 mg/kg (100cc) in 10-20 minutes, continuous infusion of magnesium sulfate 15 mg/kg/h until the end of surgery
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
severity of postoperative pain
Description
checking the postoperative pain in score at the recovery room and outpatient surgery center
Time Frame
1 hour interval
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
aged between 18-65 year-old-patient (ASA I-II) who are planned to undergoing day surgery
Exclusion Criteria:
ASA class ≥ III
suspected imbalance of electrolyte
myocardial damage or conduction delay
myasthenia gravis or other neuromuscular disease
impaired renal function
already using any type of analgesia
denial of participating in the study or not giving the informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SangHwan Do
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Bundang Hospital, department of Anesthesia and pain
City
Seongnam
State/Province
Gyenggo-do
ZIP/Postal Code
13620
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Intraoperative Magnesium Sulfate Infusion on the Postoperative Recovery
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