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CompletedNCT01153256Updated Jan 9, 2012

Intubating Condition After Magnesium Pre-treatment

An interventional study of magnesium sulphate and normal saline in Easy of Laryngoscopy Manipulation, Vocal Cord Position or Movement and Patient Reaction to Intubation and Cuff Inflation, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-01-09.

Sponsored by Seoul National University Bundang Hospital · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

Magnesium had an inhibitory effect on neuromuscular transmission and caused a decrease in muscle fiber membrane excitability. It reduces the amount of acetylcholine that is released at the motor nerve terminal by decreasing the calcium conductance of presynaptic voltage-dependent calcium channels. After pre-treatment with magnesium, an increased speed of onset and a prolongation of the recovery period of neuromuscular blockade have been observed with other non-depolarizing neuromuscular blocking agent (NMBA) such as atracurium, vecuronium and rocuronium. Rocuronium is the currently preferred NMBA used as an alternative to succinylcholine for rapid tracheal intubation. As an alternative to succinylcholine, high doses of NMBA have been tested for rapid sequence intubation. This excessively high dose of rocuronium, however, prolongs the duration of the neuromuscular block and this may not be warranted in every surgical setting.

The reduction of onset time of rocuronium by magnesium pre-treatment can make intubation condition more rapid and much better clinically. It will thus be interesting to compare intubation conditions of a standard intubation dose of rocuronium after magnesium pre-treatment with high dose of rocuronium or standard dose of rocuronium.

02

Conditions studied

  • Easy of Laryngoscopy Manipulation
  • Vocal Cord Position or Movement
  • Patient Reaction to Intubation and Cuff Inflation
  • Mean Arterial Pressure
  • Heart Rate
03

In context

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients undergoing operation under general anesthesia
  • American Society of Anesthesiologist physical status I or II
  • 20-65 year old male or female

Exclusion criteria

Exclusion Criteria:

  • hepatic or renal dysfunction
  • respiratory or cardiovascular dysfunction
  • neurologic disorder
  • neuromuscular disease
  • pregnancy
  • body mass index (BMI) >30 kg/m2 or \<16.5 kg/m2
  • anticipated difficult airway
  • higher magnesium level than normal range in preoperative evaluation
  • chronic medication with calcium channel blocker or magnesium
  • history of known allergy to magnesium sulphate or any other study drugs
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    group M

    Drug: magnesium sulphate

  • Placebo comparator
    Group R-0.6

    Drug: normal saline

  • Placebo comparator
    Group R-0.9

    Drug: normal saline

Interventions

  • Drugmagnesium sulphate

    The patients of group M receive 50 mg/kg of magnesium sulphate in 100 ml of isotonic saline over 10 min immediately before anaesthesia induction. After induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg), rocuronium 0.6 mg/kg is given over 5 s in a running infusion.

  • Drugnormal saline

    Patients in the group R-0.6 receive the same volume of isotonic saline over the same period, and rocuronium 0.6 mg/kg is given after the induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg).

  • Drugnormal saline

    Patients in the group R-0.6 receive the same volume of isotonic saline over the same period, and rocuronium 0.9 mg/kg is given after the induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg).

06

What researchers measure

Primary outcomes

  1. the intubating conditions

    The anesthesiologist also assessed the intubating conditions as per the intubation scoring system of the Good Clinical Research Practice guideline.

    Time frame: 1 minute during intervention

Secondary outcomes

  1. mean arterial pressure (MAP)

    They were recorded pre-induction (base line), just before intubation, and every minute thereafter for 5 min.

    Time frame: 5 min before intubation, immediate before intubation, post-intubation 1, 2, 3, 4, and 5 min.

  2. heart rate (HR)

    They were recorded pre-induction (base line), just before intubation, and every minute thereafter for 5 min.

    Time frame: 5 min before intubation, immediate before intubation, post-intubation 1, 2, 3, 4, and 5 min.

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do 463-707, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01153256
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Hyo-Seok Na (professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Jun 30, 2010
Start date
Dec 2010
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Jan 9, 2012
View the source record on ClinicalTrials.gov ↗

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