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Effect of Calcium Chloride on Recovery From Neuromuscular Blockade

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02213848
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
Deok Man Hong, Seoul National University Hospital

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
Residual Neuromuscular Blockade Drug: Calcium Drug: control Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
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 : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213848


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Hyun Chang Kim, M.D., Ph. D. Seoul National University Hospital
Study Director: Jae Woo Ju, M.D. Seoul National University Hospital

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Responsible Party: Deok Man Hong, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02213848    
Other Study ID Numbers: Calcium RNMB
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: August 2014
Keywords provided by Deok Man Hong, Seoul National University Hospital:
Neuromuscular blockade reversal
TOF ratio
Calcium chloride
Additional relevant MeSH terms:
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Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes
Calcium, Dietary
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents