Effect of Calcium Chloride on Recovery From Neuromuscular Blockade

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02213848
Collaborator
(none)
58
1
2
2
28.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

Detailed 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

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Calcium Chloride on Recovery From Neuromuscular Blockade in Patients Undergoing General Anesthesia
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Calcium

Administration of calcium chloride 5 mg/kg along with neostigmine 25 mcg/kg + atropine 15 mcg/kg

Drug: Calcium
Administration of calcium chloride 5 mg/kg along with neostigmine 25 mcg/kg + atropine 15 mcg/kg

Placebo Comparator: control

In the control group, all the procedures were the same with calcium group, except for the fact that calcium chloride is not administered

Drug: control
In the control group, all the procedures were the same with calcium group, except for the fact that calcium chloride is not administered

Outcome Measures

Primary Outcome Measures

  1. Time to train of-four ratio of 0.9. [At 10 minutes (expected aeverage) after the surgery]

    Train of-four will be measured using acceleromyograph.

Secondary Outcome Measures

  1. Train of-four ratio [At 5, 10, 20 minutes after the administration of reversal drug]

    Train of-four will be measured using accelerography.

  2. Length of PACU stay [At 60 minutes (expected average) after the surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 110-744

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Study Director: Hyun Chang Kim, M.D., Ph. D., Seoul National University Hospital
  • Study Director: Jae Woo Ju, M.D., Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Deok Man Hong, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02213848
Other Study ID Numbers:
  • Calcium RNMB
First Posted:
Aug 12, 2014
Last Update Posted:
Jun 30, 2015
Last Verified:
Aug 1, 2014
Keywords provided by Deok Man Hong, Associate Professor, Seoul National University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2015