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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01153256
Other study ID # Mg_rocu
Secondary ID
Status Completed
Phase N/A
First received April 9, 2010
Last updated January 6, 2012
Start date December 2010
Est. completion date March 2011

Study information

Verified date January 2012
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)


Related Conditions & MeSH terms


Intervention

Drug:
magnesium 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.
normal 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).
normal 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).

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-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 the intubating conditions The anesthesiologist also assessed the intubating conditions as per the intubation scoring system of the Good Clinical Research Practice guideline. 1 minute during intervention No
Secondary mean arterial pressure (MAP) They were recorded pre-induction (base line), just before intubation, and every minute thereafter for 5 min. 5 min before intubation, immediate before intubation, post-intubation 1, 2, 3, 4, and 5 min. No
Secondary heart rate (HR) They were recorded pre-induction (base line), just before intubation, and every minute thereafter for 5 min. 5 min before intubation, immediate before intubation, post-intubation 1, 2, 3, 4, and 5 min. No
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