Effect of Calcium Chloride on Recovery From Neuromuscular Blockade

Residual Neuromuscular Blockade Clinical Trial

Official title:

Effect of Calcium Chloride on Recovery From Neuromuscular Blockade in Patients Undergoing General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213848
• Other study ID #: Calcium RNMB
• Status: Completed
• Phase: N/A
• First received: August 4, 2014
• Last updated: June 29, 2015
• Start date: August 2014
• Est. completion date: October 2014

Study information

• Verified date: August 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of calcium chloride against residual neuromuscular blockade at the end of general anesthesia

Description:

During general anesthesia, neuromuscular blocking agent is administered to facilitate endotracheal intubation and the view of operative field. The neuromuscular blockade should be reversed at the end of anesthesia to recover spontaneous breathing of the patient.

Residual neuromuscular blockade (RNMB) is defined as train of-four ratio < 0.9. RNMB is a risk factor for postoperative pulmonary complication and increases postoperative mortality. Neostigmine is acetylcholinesterase inhibitor routinely used at the end of anesthesia to prevent RNMB. A meta-analysis, however, showed that 40 percent of patients who received intermediate-acting neuromuscular blocking agent during anesthesia showed RNMB in PACU.

Calcium triggers the release of acetylcholine from the motor nerve terminal and enhances excitation-contraction coupling in muscle. Increasing calcium concentrations decreased the sensitivity to dTc and pancuronium in an animal muscle-nerve model. The effect of calcium chloride on residual neuromuscular blockade is not studied yet.

The purpose of this study is to evaluate the effect of calcium chloride on residual neuromuscular blockade at the end of general anesthesia

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 yr

• Body mass index 15.0-25.0 kg/m2

• American Society of Anesthesiologists physical status I-III

• Scheduled for elective surgery with an expected duration of more than 60 min under general anesthesia with endotracheal intubation

Exclusion Criteria:

• Suspected difficulty airway

• Bronchial asthma, chronic obstructive pulmonary disease

• Neuromuscular disease

• Hepatic or renal dysfunction.

• Taking medications that might influence the effect of neuromuscular blocking agents

• Allergy to the medication that used in this trial

• Pregnant, or breastfeeding state

• Suspected malignant hyperthermia

• Contraindication to the medication that used in this trial

• Hypercalcemia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Residual Neuromuscular Blockade

Intervention

Drug:
• Calcium
Administration of calcium chloride 5 mg/kg along with neostigmine 25 mcg/kg + atropine 15 mcg/kg
• control
In the control group, all the procedures were the same with calcium group, except for the fact that calcium chloride is not administered

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to train of-four ratio of 0.9.	Train of-four will be measured using acceleromyograph.	At 10 minutes (expected aeverage) after the surgery	No
Secondary	Train of-four ratio	Train of-four will be measured using accelerography.	At 5, 10, 20 minutes after the administration of reversal drug	No
Secondary	Length of PACU stay		At 60 minutes (expected average) after the surgery	No