- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02100293
Effects of Magnesium Sulfate on Onset and Duration of Low Dose Rocuronium
April 15, 2016 updated by: Seoul National University Hospital
This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
- Seoul National Univ. Bundang Hospita
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-75 yr American Society of Anesthesiologists physical status 1 or 2, BMI of 20-24.9 kg/m2 scheduled for elective laryngeal microsurgery
Exclusion Criteria:
- severe respiratory or cardiac disease hepatic or renal function impairment neuromuscular disease on medications affecting neuromuscular function with known allergy to the drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: standard dose rocuronium group
pretreatment of saline 100ml and rocuronium 0.6 mg/kg
|
Patients in each group received 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia
|
Active Comparator: low dose rocuronium group
pretreatment of saline 100ml and rocuronium 0.45 mg/kg
|
Patients in each group received 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia
|
Active Comparator: low dose rocuronium plus magnesium group
pretreatment of magnesium sulfate 30 mg/kg and rocuronium 0.45 mg/kg
|
Patients in each group received the magnesium sulfate 30 mg/kg for 2 min in 0.9% normal saline (total volume 100 ml) intravenously for 5 min before induction of anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
onset time of rocuronium
Time Frame: from injection of rocuronium to T1 suppression more than 95% up to 10 minutes
|
from injection of rocuronium to T1 suppression more than 95% up to 10 minutes
|
from injection of rocuronium to T1 suppression more than 95% up to 10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
maximal suppression time and duration of rocuronium
Time Frame: time from the injection of rocuronium to T1 maximal suppression time and reversal of T1 25% up to 1 hours
|
time from the injection of rocuronium to T1 maximal suppression time and reversal of T1 25% up to 1 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intubation condition
Time Frame: intubation condition during induction of anesthesia up to 10 minutes
|
We scored intubation condition on the basis of 4 items, laryngoscopy, vocal cord position, moving of limbs, and coughing.
|
intubation condition during induction of anesthesia up to 10 minutes
|
surgical condition
Time Frame: intraoperative surgical condition
|
to score a surgical condition according to 7 point likers scale
|
intraoperative surgical condition
|
postoperative sore throat
Time Frame: postoperative sore throat up to 4 hours
|
postoperative sore throat up to 4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sang Hwan Do, Seoul National Univ. Bundang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
December 11, 2013
First Submitted That Met QC Criteria
March 26, 2014
First Posted (Estimate)
March 31, 2014
Study Record Updates
Last Update Posted (Estimate)
April 18, 2016
Last Update Submitted That Met QC Criteria
April 15, 2016
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease
- 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-1307/209-006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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