Intubating Condition After Magnesium Pre-treatment

Heart Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153256
• Other study ID #: Mg_rocu
• 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

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

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