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A randomized crossover study on the effect of train-of-four monitoring with clinical assessment vs clinical assessment alone on continuous neuromuscular blockade dose in pediatric intensive care patients

A randomized crossover study on the effect of train-of-four monitoring with clinical assessment vs clinical assessment alone on continuous neuromuscular blockade dose in pediatric intensive care patients

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240328002
Enrollment
18
Registered
2024-03-28
Start date
2024-04-27
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular blockade Pediatric intensive care unit Neuromuscular blocking agents Neuromuscular monitoring

Interventions

Patient receives train-of-four test at ulnar nerve in the morning and in the evening. The test result is revealed to the physician in charge. Train-of-four test result, together with clinical assessme
s movement, are used for titration of cisatracurium dose.,Patient receives train-of-four test at ulnar nerve in the morning and in the evening. The test result is CONCEALED from the clinical team. Onl
s movement is used for titration of cisatracurium dose.
Experimental Device,No Intervention No treatment
Train-of-four monitoring with clinical assessment,Clinical assessment alone

Sponsors

Dr. Suvikrom Law
Lead Sponsor
Dr. Thakoon Butpech
Collaborator

Eligibility

Sex/Gender
All
Age
1 Months to 18 Years

Inclusion criteria

Inclusion criteria: 1. Patients admitted to PICU 2. Plan to receive continuous IV cisatracurium infusion for at least 2 days

Exclusion criteria

Exclusion criteria: 1. Known or suspected neuromuscular disease 2. Fracture of both hands or wrists 3. Allergic to cisatracurium or atracurium 4. Patient having medical devices on both hands that preclude TOF testing 5. Patient having permanent or temporary cardiac pacemaker

Design outcomes

Primary

MeasureTime frame
Total daily cisatracurium dose From 7am to 7am the next day Total daily cisatracurium dose measured in mg with one decimal point

Secondary

MeasureTime frame
Train-of-four result Twice per day, in the morning and evening of each day Train-of-four test at ulnar nerve measured as number of twitches (0, 1, 2, 3, or 4 twitches),Clinical assessment of neuromuscular blockade depth Twice per day, in the morning and evening of each day Clinical assessment of patient's movement, ventilator synchrony/triggering, cough and gag; categorized as over-paralyzed, well-paralyzed and under-paralyzed.,Total daily sedative dose from 7am to 7 am the next day Total daily sedative dose measured in mg or micrograms as appropriate

Countries

Thailand

Contacts

Public ContactSuvikrom Law

Faculty of Medicine Siriraj Hospital, Mahidol University

suvikrom.law@mahidol.ac.th024195804

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026