Effects of Magnesium Sulfate on Onset and Duration of Low Dose Rocuronium

Observation of Neuromuscular Block Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100293
• Other study ID #: B-1307/209-006
• Status: Completed
• Phase: N/A
• First received: December 11, 2013
• Last updated: April 15, 2016
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Intubation Condition
• Observation of Neuromuscular Block
• Surgical Condition

Intervention

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
• saline
Patients in each group received 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univ. Bundang Hospita	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	intubation condition	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	No
Other	surgical condition	to score a surgical condition according to 7 point likers scale	intraoperative surgical condition	No
Other	postoperative sore throat		postoperative sore throat up to 4 hours	No
Primary	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	No
Secondary	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	No