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

NCT02100293 | Completed

• 1 other identifier: B-1307/209-006
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Observation of Neuromuscular Block; Intubation Condition; Surgical Condition

Keywords

magnesium sulfate, rocuronium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Outcomes (3)

• intubation condition

  intubation condition during induction of anesthesia up to 10 minutes

• surgical condition

  intraoperative surgical condition

• postoperative sore throat

  postoperative sore throat up to 4 hours

Study Arms (3)

standard dose rocuronium group

ACTIVE COMPARATOR

pretreatment of saline 100ml and rocuronium 0.6 mg/kg

Drug: saline

low dose rocuronium group

ACTIVE COMPARATOR

pretreatment of saline 100ml and rocuronium 0.45 mg/kg

Drug: saline

low dose rocuronium plus magnesium group

ACTIVE COMPARATOR

pretreatment of magnesium sulfate 30 mg/kg and rocuronium 0.45 mg/kg

Drug: magnesium sulfate 30 mg/kg

Interventions

magnesium sulfate 30 mg/kg DRUG

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

low dose rocuronium plus magnesium group

saline DRUG

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

low dose rocuronium group; standard dose rocuronium group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• yr American Society of Anesthesiologists physical status 1 or 2, BMI of 20-24.9 kg/m2 scheduled for elective laryngeal microsurgery

You may not qualify if:

• severe respiratory or cardiac disease hepatic or renal function impairment neuromuscular disease on medications affecting neuromuscular function with known allergy to the drugs

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National Univ. Bundang Hospita

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Interventions

Magnesium Sulfate; Sodium Chloride

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Sang Hwan Do

  Seoul National Univ. Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: March 31, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 18, 2016

Record last verified: 2015-07

Locations

KR (1)