The Effect of Intraoperative Magnesium Sulfate Infusion on the Postoperative Recovery

The Effect of Intraoperative Magnesium Sulfate Infusion on the Postoperative Recovery After Outpatient Surgery

Evaluating analgesic effect of intraoperative magnesium sulfate infusion in the outpatient surgery case

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Normal saline; Drug: Magnesium Sulfate

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyenggo-do
    • Seongnam, Gyenggo-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital, department of Anesthesia and pain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Normal saline group; after loading normal saline 100cc in 10-20 minutes, continuous infusion of normal saline until the end of surgery	Drug: Normal saline; Placebo
Active Comparator: Magnesium group; 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	Drug: Magnesium Sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of postoperative pain	checking the postoperative pain in score at the recovery room and outpatient surgery center	1 hour interval

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Study Chair: SangHwan Do, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2016
• Primary Completion (Actual): November 24, 2017
• Study Completion (Actual): November 24, 2017

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 19, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: B-1608-360-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No