MgSO4 Combined With Rocuronium Priming

Muscle Relaxation Clinical Trial

Official title:

MgSO4 Combined With Rocuronium Priming

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01389791
• Other study ID #: Mg priming
• Status: Recruiting
• Phase: N/A
• First received: May 26, 2011
• Last updated: January 6, 2012
• Start date: May 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Seoul National University Bundang Hospital
• Contact: Mihyun Kim, MD
• Phone: 82-31-787-2034
• Email: snmd56[@]yahoo.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Priming with either rocuronium or MgSO4 is known to accelerate the effect of rocuronium on muscle relaxation. The purpose of this study is to define the effect of MgSO4 on the rocuronium-priming.

Description:

Acceleration of muscle relaxation is beneficial in rapid-sequence intubation. If MgSO4 combined with priming is efficient in accelerating muscle relaxation, it would be an interesting alternative to rapid-sequence intubation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients of ASA ?-?

• aged 18~65

• scheduled to undergo elective surgery under general anesthesia

Exclusion Criteria:

• risk of pulmonary aspiration

• anticipated airway difficulty

• reactive airway disease

• allergic to study drugs

• neuromuscular / cardiovascular/ renal/ hepatic disease

• atrioventricular conduction disturbance

• BMI < 18.5 or > 24.9

• chronic treatment with calcium channel blocker

• medications which affect muscle relaxation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Relaxation

Intervention

Drug:
• magnesium sulfate
Patients in this group receive intravenous MgSO4 50mg/kg before administration of rocuronium (induction dose).
• priming
Patients in this group receive 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium.
• magnesium sulfate and priming
Patients in this group receive MgSO4 50mg/kg and 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium.

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university Bundang hospital	Seongnam	Kyoung-ki-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time from injection of induction dose of rocuronium until 95% depression of TOF		time from injection of induction dose of rocuronium until 95% depression of TOF, upto 5 min	No
Secondary	rocuronium duration	time from injection of induction dose of rocuronium until train-of-four count reaches two.	time from injection of induction dose of rocuronium until train-of-four count reaches two.	No
Secondary	intubating condition	rapid sesequence intubation condition is evaluated.	time from injection of induction dose of rocuronium until tracheal intubation.	Yes