NCT02213848

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

June 30, 2015

Status Verified

August 1, 2014

Enrollment Period

2 months

First QC Date

August 4, 2014

Last Update Submit

June 29, 2015

Conditions

Residual Neuromuscular Blockade

Keywords

Neuromuscular blockade reversalTOF ratioCalcium chloride

Outcome Measures

Primary Outcomes (1)

  • Time to train of-four ratio of 0.9.

    Train of-four will be measured using acceleromyograph.

    At 10 minutes (expected aeverage) after the surgery

Secondary Outcomes (2)

  • Train of-four ratio

    At 5, 10, 20 minutes after the administration of reversal drug

  • Length of PACU stay

    At 60 minutes (expected average) after the surgery

Study Arms (2)

Calcium

EXPERIMENTAL

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

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

Drug: control

Interventions

CalciumDRUG

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

Calcium
controlDRUG

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

control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Calcium

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Hyun Chang Kim, M.D., Ph. D.

    Seoul National University Hospital

    STUDY DIRECTOR

  • Jae Woo Ju, M.D.

    Seoul National University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 4, 2014

First Posted

August 12, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

June 30, 2015

Record last verified: 2014-08

Locations

KR(1)