Effect of Calcium Chloride on Recovery From Neuromuscular Blockade

June 29, 2015 updated by: Deok Man Hong, Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to train of-four ratio of 0.9.
Time Frame: At 10 minutes (expected aeverage) after the surgery
Train of-four will be measured using acceleromyograph.
At 10 minutes (expected aeverage) after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Train of-four ratio
Time Frame: At 5, 10, 20 minutes after the administration of reversal drug
Train of-four will be measured using accelerography.
At 5, 10, 20 minutes after the administration of reversal drug
Length of PACU stay
Time Frame: At 60 minutes (expected average) after the surgery
At 60 minutes (expected average) after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 4, 2014

First Submitted That Met QC Criteria

August 7, 2014

First Posted (Estimate)

August 12, 2014

Study Record Updates

Last Update Posted (Estimate)

June 30, 2015

Last Update Submitted That Met QC Criteria

June 29, 2015

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Calcium RNMB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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