Clinical trial NCT05724550: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Block, Residual
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 73
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Diaphragm excursion ratio
timeFrame: during diaphragm ultrasound procedure after reversal of neuromuscular blocking agent (T1), an average of 10 minute
Secondary outcomes:
measure: modified lung ultrasound score before neuromuscular blockade (LUS_T0)
timeFrame: during lung ultrasound procedure before neuromuscular blocking agent (T0), an average of 10 minutes
measure: modified lung ultrasound score after reversing neuromuscular blockade (LUS_T1)
timeFrame: during lung ultrasound procedure after reversing neuromuscular blocking agent(T1), an average of 10 minutes
measure: modified lung ultrasound score at post-anesthesia care unit (PACU) (LUS_T2)
timeFrame: 30 minutes after entering the post-anesthesia care unit (T2)
measure: total recovery time (sec)
timeFrame: From injection of neuromuscular block reversal agent to extubation, not to exceed 20 minutes
measure: perioperative respiratory adverse events
timeFrame: intraoperative
measure: length of stay in post-anesthesia care unit
timeFrame: from entering the post-anesthesia care unit to discharge from the post-anesthesia care unit, up to 24 hours
measure: Adverse events occurred during post-anesthesia care unit stay
timeFrame: from entering the post-anesthesia care unit to discharge from the post-anesthesia care unit, up to 24 hours
measure: postoperative pulmonary complication
timeFrame: from entering the general ward after surgery to discharge from hospital, up to 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongrogu
Study officials:
References: