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Neuromuscular Block and Anesthetic Depth Monitoring

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ClinicalTrials.gov Identifier: NCT02575443
Recruitment Status : Completed
First Posted : October 14, 2015
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital

Study Description
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Brief Summary:
The purpose of this study is to evaluated whether the depth of neuromuscular block may affect the unicon value of anesthetic depth monitoring system (ADMS).

Condition or disease Intervention/treatment Phase
Cholecystectomy, Laparoscopic Drug: Rocuronium (MB group) Drug: Rocuronium (DB group) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Moderate block (MB) group Drug: Rocuronium (MB group)
Count of train-of-four: 1-2 Titration of rocuronium dose
Experimental: Deep block (DB) group Drug: Rocuronium (DB group)
Post-tetanic count: 1-2 Titration of rocuronium dose


Outcome Measures
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Primary Outcome Measures :
  1. Total infused dose of propofol [ Time Frame: At 1 min after the anesthesia is finished ]

Secondary Outcome Measures :
  1. Electromyographic index presented on the anesthetic depth monitoring system [ Time Frame: Through study completion, an average of 2 hours ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gall bladder disease
  • American Society of Anesthesiologist physical status 1 or 2

Exclusion Criteria:

  • Pregnancy
  • Body mass index < 16
  • Body mass index >30
  • Neuromuscular disease
  • Previous intraabdominal surgery
Contacts and Locations
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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): NCT02575443


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Hyo-Seok Na 82, Gumi 173
More Information
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Responsible Party: Hyo-Seok Na, Dr, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02575443    
Other Study ID Numbers: ADMS NMD depth
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs