(MOTOR Study) Neuromuscular MOniTOring in pediatric anesthesia. Randomized clinical study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

IRCCS Istituto Giannina Gaslini

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

20 Jan 2026 → ongoing

Decision date (initial)

2025-06-11

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-517057-27-00

WHO UTN

U1111-1314-5605

ClinicalTrials.gov

NCT06331611

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

The main objective of the study is to analyze the frequency of sugammadex use, with and without the aid of quantitative neuromuscular monitoring.

Secondary objectives 6

1. how quantitative neuromuscolar monitoring can optimize the state of curarization in the intra- and post- operative phase
2. the difference in the dose of sugammadex (mg/kg) used in the two arms
3. whether there are differences in the choice of neuromuscular blocker dosage based on the presence or absence of quantitative neuromuscular monitoring
4. additional information regarding the time required to achieve extubation and the need for further administration of the antagonist drug with and without the presence of quantitative neuromuscular monitoring
5. the incidence of adverse events with and without the presence of quantitative neuromuscular monitoring
6. the quality of awakening with and without the presence of quantitative neuromuscular monitoring

Conditions and MedDRA coding

patients scheduled to undergo elective surgical procedures with general anesthesia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Children > 2 years or ≤ 16 years
2. Children who will undergo surgery in general anesthesia with tracheal intubation and receiving a non-depolarizing blockade agent,
3. Acquisition of informed consent by both legally recognized representatives, capable of understanding the document and providing consent on behalf of the participant.

Exclusion criteria 15

1. Children ≤ 2 years or > 16 years of age
2. Children with an ASA classification ≥ 3
3. Presence of neuromuscular disease, channelopathy, peripheral neuropathy or any clinical condition that could alter the neuromuscular function
4. Presence of contraindications to or impossible use of the TetraGraph monitoring: patients too small for the TetraSens Pediatric, skin lesions or tattoos in or in proximity of all the possible sites of the TetraSens Pediatric, implanted electronic device (such as a cardiac pacemaker), combined intraoperative use of short wave or microwave, epileptic patients, amputations or limb malformations.
5. Confirmed or suspected hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents or sugammadex
6. Conditions may affect the pharmacokinetics and/or pharmacodynamics of rocuronium bromide (biliary tract/hepatic/renal impairment, prolonged circulation time such as cardiovascular disease or edematous state, obesity, hypothermia, burn patients, severe electrolyte disturbances, altered blood pH or severe dehydration)
7. Confirmed or suspected contraindication to sugammadex (hypersensitivity to sugammadex or to any of the excipients)
8. Conditions may affect the pharmacokinetics and/or pharmacodynamics of sugammadex (increased risk of bleeding such as hereditary deficiencies of vitamin K-dependent coagulation factors, pre-existing coagulopathies. anticoagulants, renal and hepatic dysfunction, prolonged circulation time such as cardiovascular disease or edematous state, drugs such as Toremifene, EV fusidic acid, Hormonal contraceptives
9. Renal impairment, defined as GFR < 60 mL/min/1.73 m2, as calculated with Schwartz formula (eGFR = 0.5 × height (cm)/plasma creatinine)
10. Biliary tract and hepatic impairment, defined as levels of AST or ALT 3 times above the upper limit of the range of normality, or levels of total bilirubin 2 times above the upper limit of the range of normality, as reported by the local lab
11. Cardiac surgery
12. Emergency surgery
13. Known hypersensitivity to any of the study drugs or to any of their components, or to any component of the study drugs
14. Pregnancy or potential pregnancy
15. Any specific contraindication to any aspect of the protocol

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the percentage of Sugammadex use in each arm at the end of anesthesia

Secondary endpoints 10

1. The time needed to extubate patients
2. the difference in the dose of sugammadex (mg/kg) in the two arms
3. The frequency of respiratory complications during and after extubation (residual paralysis, upper airway obstruction, laryngospasm, bronchospasm)
4. The best dose needed to reach the reversal of the neuromuscular blockade, indirectly evaluated from the need to administer further doses of sugammadex after extubation
5. Possible adverse reactions to the use of sugammadex or to the use of TetraGraph System
6. The incidence of extubation with residual neuromuscular paralysis (TOFr < 0.9)
7. Quality of awakening and occurrence of any episodes of agitation/delirium (Richmond Agitation-Sedation Scale -RASS)
8. The reliability of using quantitative neuromuscular monitoring in pediatrics, in the anesthetist's opinion
9. The incidence of SpO2 < 90% in the post-operative acute care unit (PACU)
10. The frequency of sugammadex use in patients with TOFr ≥ 0.9

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

IRCCS Istituto Giannina Gaslini

Sponsor organisation

IRCCS Istituto Giannina Gaslini

Address

Via Gerolamo Gaslini 5

City

Genoa

Postcode

16147

Country

Italy

Scientific contact point

Organisation

IRCCS Istituto Giannina Gaslini

Contact name

Nicola Disma

Public contact point

Organisation

IRCCS Istituto Giannina Gaslini

Contact name

Nicola Disma

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications