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Dose for Deep Neuromuscular Blockade Deciding Factor of Neuromuscular Blocker Dose for Deep Neuromuscular Blockade

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ClinicalTrials.gov Identifier: NCT04688268
Recruitment Status : Not yet recruiting
First Posted : December 29, 2020
Last Update Posted : December 30, 2020
Sponsor:
Information provided by (Responsible Party):
JiWon Han, Seoul National University Bundang Hospital

Study Description
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Brief Summary:
Find out the deciding factor(total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index, skeletal muscle mass, body fat) of neuromuscular blocker dose for deep neuromuscular blockade.

Condition or disease Intervention/treatment
Laparoscopic Surgery Drug: deep neuromuscular blockade

Detailed Description:
Before the surgery, total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index were measured by height and weight and skeletal muscle mass and body fat were measured by Bioelectrical impedance analysis (InbodyH20N). Find the highest correlation between the 8 factors (total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index, skeletal muscle mass, body fat) and the amount of rocuronium administered to deep neuromuscular blockade.
Study Design
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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Find Out the Deciding Factor of Neuromuscular Blocker Dose for Deep Neuromuscular Blockade
Estimated Study Start Date : January 10, 2021
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
deep neuromuscular blockade
patients who underwent surgery with deep neuromuscular blockade
 Drug: deep neuromuscular blockade
Train of Four=0/4, Post tetanic count 1-2


Outcome Measures
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Primary Outcome Measures :
  1. the highest correlation coefficient [ Time Frame: preoperative 1 days to postoperative 1 days ]
    the relationship of rocuronium for deep neuromuscular blockade and 8 factors (corrected body weight, ideal body weight, lean body weight, fat-free mass, body mass index, skeletal muscle mass, body fat)


Secondary Outcome Measures :
  1. onset time of rocuronium [ Time Frame: preoperative 1 days to postoperative 1 days ]
    time from injection of rocuronium 0.6 mg/kg(TBW) to TOF ratio is less than 0.05

  2. Time to deep neuromuscular blockade [ Time Frame: preoperative 1 days to postoperative 1 days ]
    time from injection of rocuronium 0.6 mg/kg(TBW) to PTC 1

  3. Recovery time [ Time Frame: preoperative 1 days to postoperative 1 days ]
    time from sugammadex injection to TOF ratio > 0.9


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
Sampling Method:   Probability Sample
Study Population
Patients aged 20-80 and American Society of Anesthesiology Physical Grade (ASA) I-II, who undergo laparoscopic surgery for at least 2 hours under general anesthesia.
Criteria

Inclusion Criteria:

  • patients aged 20-80 and American Society of Anesthesiology Physical Grade (ASA) I-II, who undergo laparoscopic surgery for at least 2 hours under general anesthesia

Exclusion Criteria:

  • kidney disease (GFR<60)
  • allergy to study drugs
  • decline participation
  • side effect of propofol and remifentanil
  • when anesthesia does not maintain the level of alertness (BIS) below 60 even when the anesthetic dose is increased, or when hemodynamic instability such as bradycardia and hypotension appears
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): NCT04688268


Contacts
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Contact: Jiwon Han, Dr 82-10-3447-1988 hanjiwon@snubh.org
Contact: Ah-young Oh, Dr 82-31-787-7506 oay1@snubh.org

Sponsors and Collaborators
Seoul National University Bundang Hospital
More Information
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Publications:

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Responsible Party: JiWon Han, principal investigator, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT04688268    
Other Study ID Numbers: B-2008/633-302
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: December 30, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by JiWon Han, Seoul National University Bundang Hospital:
laparoscopic surgery
deep neuromuscular blockade