Back to resultsDiaphragm Function After Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex or Neostigmine in Children
Primary Purpose
Neuromuscular Block, Residual
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sugammadex
Neostigmine
Sponsored by
About this trial
This is an interventional prevention trial for Neuromuscular Block, Residual
Eligibility Criteria
Inclusion Criteria: Patients between the ages of 2 and 7 who are scheduled for surgery lasting more than 1 hour under general anesthesia using a neuromuscular blocking agent Exclusion Criteria: Patients with a history of severe respiratory disease with a high risk of bronchoconstriction Patients with abnormal findings on preoperative chest radiography such as severe atelectasis, pneumothorax, pleural effusion, or pneumonia. Patients with severe renal or liver disease, or neuromuscular disease Patients with a history of allergy to drugs (sugammadex, rocuronium neostigmine) Patients with significant bradycardia Patients scheduled for surgery where estimated blood loss during surgery is expected to be more than 30% of estimated blood volume, or cases where fluid imbalance is expected to be severe during surgery patients scheduled for lung parenchyme/diaphragm/thoracic surgery other researchers considered it inappropriate to participate in research.
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Neostigmine
Sugammadex
Arm Description
The use of neostigmine 0.02mg/kg for reversal of neuromuscular blocking agent.
The use of sugammadex 2mg/kg for reversal of neuromuscular blocking agent.
Outcomes
Primary Outcome Measures
Diaphragm excursion ratio
The ratio of diaphragm excursion at the time before injecting neuromuscular blocking agent before surgery (T0) and diaphragm excursion at the time after reversal of neuromuscular blocking agent (T1)
Secondary Outcome Measures
modified lung ultrasound score before neuromuscular blockade (LUS_T0)
Both lung ultrasound score can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss)
modified lung ultrasound score after reversing neuromuscular blockade (LUS_T1)
Both lung ultrasound score can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss)
modified lung ultrasound score at post-anesthesia care unit (PACU) (LUS_T2)
Both lung ultrasound score can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss)
total recovery time (sec)
time from injection of a neuromuscular block reversal agent to extubation
perioperative respiratory adverse events
laryngospasm, bronchospasm, desaturation (SpO2 < 95%), airway obstruction, severe coughing, postoperative stridor during the emergence period
length of stay in post-anesthesia care unit
Length of stay in post-anesthesia care unit
Adverse events occurred during post-anesthesia care unit stay
agitation, stridor, desaturation (SpO2<95%), nausea, vomiting, bradycardia, somnolence, need for oxygen support
postoperative pulmonary complication
pneumonia, respiratory failure, pleural effusion, atelectasis described in postoperative chest radiography, pneumothorax, bronchospasm, aspiration pneumonia
Full Information
NCT ID
NCT05724550
First Posted
January 15, 2023
Last Updated
April 21, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05724550
Brief Title
Diaphragm Function After Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex or Neostigmine in Children
Official Title
Diaphragm and Lung Ultrasound After Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex or Neostigmine in Children Undergoing Surgery : A Randomized Double-blind Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
February 15, 2025 (Anticipated)
Study Completion Date
April 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is to evaluate the recovery of diaphragm function and atelectasis after reversal of neuromuscular blockade with Neostigmine and Sugammadex using lung ultrasound and diaphragm ultrasound for children aged 2 to 7 who are scheduled for the surgical procedure under general anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Block, Residual
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neostigmine
Arm Type
Active Comparator
Arm Description
The use of neostigmine 0.02mg/kg for reversal of neuromuscular blocking agent.
Arm Title
Sugammadex
Arm Type
Experimental
Arm Description
The use of sugammadex 2mg/kg for reversal of neuromuscular blocking agent.
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Other Intervention Name(s)
bridion
Intervention Description
Sugammadex(100mg/mL), 2mg/kg
After confirming Train-of-four counts 4, patients allocated to sugammadex group receive sugammadex 2mg/kg for reversal of rocuronium at the end of the surgery.
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Other Intervention Name(s)
Neostigmine methylsulfate
Intervention Description
Neostigmine methylsulfate(0.5mg/mL) 0.02mg/kg
After confirming Train-of-four counts 4, patients allocated to neostigmine group receive neostigmine 0.02mg/kg (maximum 5mg) combined with atropine 0.02mg/kg for reversal of rocuronium at the end of the surgery.
Primary Outcome Measure Information:
Title
Diaphragm excursion ratio
Description
The ratio of diaphragm excursion at the time before injecting neuromuscular blocking agent before surgery (T0) and diaphragm excursion at the time after reversal of neuromuscular blocking agent (T1)
Time Frame
during diaphragm ultrasound procedure after reversal of neuromuscular blocking agent (T1), an average of 10 minute
Secondary Outcome Measure Information:
Title
modified lung ultrasound score before neuromuscular blockade (LUS_T0)
Description
Both lung ultrasound score can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss)
Time Frame
during lung ultrasound procedure before neuromuscular blocking agent (T0), an average of 10 minutes
Title
modified lung ultrasound score after reversing neuromuscular blockade (LUS_T1)
Description
Both lung ultrasound score can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss)
Time Frame
during lung ultrasound procedure after reversing neuromuscular blocking agent(T1), an average of 10 minutes
Title
modified lung ultrasound score at post-anesthesia care unit (PACU) (LUS_T2)
Description
Both lung ultrasound score can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss)
Time Frame
30 minutes after entering the post-anesthesia care unit (T2)
Title
total recovery time (sec)
Description
time from injection of a neuromuscular block reversal agent to extubation
Time Frame
From injection of neuromuscular block reversal agent to extubation, not to exceed 20 minutes
Title
perioperative respiratory adverse events
Description
laryngospasm, bronchospasm, desaturation (SpO2 < 95%), airway obstruction, severe coughing, postoperative stridor during the emergence period
Time Frame
intraoperative
Title
length of stay in post-anesthesia care unit
Description
Length of stay in post-anesthesia care unit
Time Frame
from entering the post-anesthesia care unit to discharge from the post-anesthesia care unit, up to 24 hours
Title
Adverse events occurred during post-anesthesia care unit stay
Description
agitation, stridor, desaturation (SpO2<95%), nausea, vomiting, bradycardia, somnolence, need for oxygen support
Time Frame
from entering the post-anesthesia care unit to discharge from the post-anesthesia care unit, up to 24 hours
Title
postoperative pulmonary complication
Description
pneumonia, respiratory failure, pleural effusion, atelectasis described in postoperative chest radiography, pneumothorax, bronchospasm, aspiration pneumonia
Time Frame
from entering the general ward after surgery to discharge from hospital, up to 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients between the ages of 2 and 7 who are scheduled for surgery lasting more than 1 hour under general anesthesia using a neuromuscular blocking agent
Exclusion Criteria:
Patients with a history of severe respiratory disease with a high risk of bronchoconstriction
Patients with abnormal findings on preoperative chest radiography such as severe atelectasis, pneumothorax, pleural effusion, or pneumonia.
Patients with severe renal or liver disease, or neuromuscular disease
Patients with a history of allergy to drugs (sugammadex, rocuronium neostigmine)
Patients with significant bradycardia
Patients scheduled for surgery where estimated blood loss during surgery is expected to be more than 30% of estimated blood volume, or cases where fluid imbalance is expected to be severe during surgery
patients scheduled for lung parenchyme/diaphragm/thoracic surgery
other researchers considered it inappropriate to participate in research.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung-Bin Park, M.D.
Phone
220723664
Ext
82
Email
jb4001@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongrogu
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung-Bin Park, M.D.
Phone
220723664
Ext
82
Email
jb4001@snu.ac.kr
12. IPD Sharing Statement
Learn more about this trial
Diaphragm Function After Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex or Neostigmine in Children
We'll reach out to this number within 24 hrs