Effects of Magnesium Sulfate on Onset and Duration of Low Dose Rocuronium
Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02100293
Collaborator
(none)
84
1
3
14
6
Study Details
Study Description
Brief Summary
This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date
:
Oct 1, 2013
Actual Primary Completion Date
:
Dec 1, 2014
Actual Study Completion Date
:
Dec 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: standard dose rocuronium group pretreatment of saline 100ml and rocuronium 0.6 mg/kg |
Drug: saline
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 |
Drug: saline
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 |
Drug: magnesium sulfate 30 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
|
Outcome Measures
Primary Outcome Measures
- onset time of rocuronium [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
- maximal suppression time and duration of rocuronium [time from the injection of rocuronium to T1 maximal suppression time and reversal of T1 25% up to 1 hours]
Other Outcome Measures
- intubation condition [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.
- surgical condition [intraoperative surgical condition]
to score a surgical condition according to 7 point likers scale
- postoperative sore throat [postoperative sore throat up to 4 hours]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National Univ. Bundang Hospita | Seongnam-si | Gyeonggi-do | Korea, Republic of | 463-707 |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
- Principal Investigator: Sang Hwan Do, Seoul National Univ. Bundang Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02100293
Other Study ID Numbers:
- B-1307/209-006
First Posted:
Mar 31, 2014
Last Update Posted:
Apr 18, 2016
Last Verified:
Jul 1, 2015
Keywords provided by Seoul National University Hospital
Additional relevant MeSH terms: