Effect of Calcium Chloride on Recovery From Neuromuscular Blockade

NCT ID: NCT02213848

Last Updated: 2015-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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

Conditions

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Residual Neuromuscular Blockade

Keywords

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Neuromuscular blockade reversal TOF ratio Calcium chloride

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Calcium

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

Group Type EXPERIMENTAL

Calcium

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

control

Intervention Type DRUG

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

Interventions

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Calcium

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Deok Man Hong

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyun Chang Kim, M.D., Ph. D.

Role: STUDY_DIRECTOR

Seoul National University Hospital

Jae Woo Ju, M.D.

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Calcium RNMB

Identifier Type: -

Identifier Source: org_study_id