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Clinical Trials/NCT01153256
NCT01153256CompletedNot Applicable

The Influence of Magnesium Sulphate Pretreatment on Intubating Conditions During Rapid Sequence Induction

Seoul National University Bundang Hospital1 site in 1 country168 target enrollmentStarted: December 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
168
Locations
1
Primary Endpoint
the intubating conditions

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
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

  • 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

Arms & Interventions

group M

Experimental

Intervention: magnesium sulphate (Drug)

Group R-0.6

Placebo Comparator

Intervention: normal saline (Drug)

Group R-0.9

Placebo Comparator

Intervention: normal saline (Drug)

Outcomes

Primary Outcomes

the intubating conditions

Time Frame: 1 minute during intervention

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

Secondary Outcomes

  • mean arterial pressure (MAP)(5 min before intubation, immediate before intubation, post-intubation 1, 2, 3, 4, and 5 min.)
  • heart rate (HR)(5 min before intubation, immediate before intubation, post-intubation 1, 2, 3, 4, and 5 min.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hyo-Seok Na

professor

Seoul National University Bundang Hospital

Study Sites (1)

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