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Effect of Calcium Chloride on Recovery From Neuromuscular Blockade

Primary Purpose

Residual Neuromuscular Blockade

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Calcium
control
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Residual Neuromuscular Blockade focused on measuring Neuromuscular blockade reversal, TOF ratio, Calcium chloride

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Calcium

control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time to train of-four ratio of 0.9.
Train of-four will be measured using acceleromyograph.

Secondary Outcome Measures

Train of-four ratio
Train of-four will be measured using accelerography.
Length of PACU stay

Full Information

First Posted
August 4, 2014
Last Updated
June 29, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02213848
Brief Title
Effect of Calcium Chloride on Recovery From Neuromuscular Blockade
Official Title
Effect of Calcium Chloride on Recovery From Neuromuscular Blockade in Patients Undergoing General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Residual Neuromuscular Blockade
Keywords
Neuromuscular blockade reversal, TOF ratio, Calcium chloride

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcium
Arm Type
Experimental
Arm Description
Administration of calcium chloride 5 mg/kg along with neostigmine 25 mcg/kg + atropine 15 mcg/kg
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
In the control group, all the procedures were the same with calcium group, except for the fact that calcium chloride is not administered
Intervention Type
Drug
Intervention Name(s)
Calcium
Intervention Description
Administration of calcium chloride 5 mg/kg along with neostigmine 25 mcg/kg + atropine 15 mcg/kg
Intervention Type
Drug
Intervention Name(s)
control
Intervention Description
In the control group, all the procedures were the same with calcium group, except for the fact that calcium chloride is not administered
Primary Outcome Measure Information:
Title
Time to train of-four ratio of 0.9.
Description
Train of-four will be measured using acceleromyograph.
Time Frame
At 10 minutes (expected aeverage) after the surgery
Secondary Outcome Measure Information:
Title
Train of-four ratio
Description
Train of-four will be measured using accelerography.
Time Frame
At 5, 10, 20 minutes after the administration of reversal drug
Title
Length of PACU stay
Time Frame
At 60 minutes (expected average) after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Chang Kim, M.D., Ph. D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jae Woo Ju, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Calcium Chloride on Recovery From Neuromuscular Blockade

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