Residual Neuromuscular BlockadeNCT02213848
Effect of Calcium Chloride on Recovery From Neuromuscular Blockade
A study testing Calcium in people with Residual Neuromuscular Blockade, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of calcium chloride against residual neuromuscular blockade at the end of general anesthesia Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Residual Neuromuscular Blockade
- What is being tested?
- Calcium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pregnant, or breastfeeding state
- Suspected malignant hyperthermia
- Contraindication to the medication that used in this trial
- Hypercalcemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Residual Neuromuscular Blockade
- Being tested
- Calcium, control
- Keywords
- Neuromuscular blockade reversal, TOF ratio, Calcium chloride
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalciumDrug
Administration of calcium chloride 5 mg/kg along with neostigmine 25 mcg/kg + atropine 15 mcg/kg
controlDrug
In the control group, all the procedures were the same with calcium group, except for the fact that calcium chloride is not administered
| Study group | Role | What they receive |
|---|---|---|
| Calcium | Experimental | Administration of calcium chloride 5 mg/kg along with neostigmine 25 mcg/kg + atropine 15 mcg/kg Receives: Drug: Calcium |
| control | Placebo comparator | In the control group, all the procedures were the same with calcium group, except for the fact that calcium chloride is not administered Receives: Drug: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to train of-four ratio of 0.9.
Train of-four will be measured using acceleromyograph.
Measured: At 10 minutes (expected aeverage) after the surgery
Secondary outcomes (2)
Train of-four ratio
Train of-four will be measured using accelerography.
Measured: At 5, 10, 20 minutes after the administration of reversal drug
Length of PACU stay
Measured: At 60 minutes (expected average) after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Residual Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deok Man Hong, Seoul National University Hospital
- Investigators
- Hyun Chang Kim, M.D., Ph. D., Study director, Seoul National University HospitalJae Woo Ju, M.D., Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213848
- Sponsor's protocol ID
- Calcium RNMB
- Status last verified
- Aug 2014
- First submitted
- 4 Aug 2014
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calcium Chloride on Recovery From Neuromuscular Blockade in Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT02213848
- Acronym / sponsor ID
- Calcium RNMB
- Conditions
- Residual Neuromuscular Blockade
- Keywords
- Neuromuscular blockade reversal, TOF ratio, Calcium chloride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium | Experimental | Drug: CalciumAdministration of calcium chloride 5 mg/kg along with neostigmine 25 mcg/kg + atropine 15 mcg/kg |
| control | Placebo comparator | Drug: controlIn the control group, all the procedures were the same with calcium group, except for the fact that calcium chloride is not administered |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalciumAdministration of calcium chloride 5 mg/kg along with neostigmine 25 mcg/kg + atropine 15 mcg/kg | Drug | Calcium |
| controlIn the control group, all the procedures were the same with calcium group, except for the fact that calcium chloride is not administered | Drug | control |
Primary outcome
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.
2 secondary outcomes
Train of-four ratio
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Chang Kim, M.D., Ph. D. study director
Seoul National University Hospital
Jae Woo Ju, M.D. study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium in people with Residual Neuromuscular Blockade, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to train of-four ratio of 0.9. (time frame: At 10 minutes (expected aeverage) after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015.