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

Phase 1

Recruiting

• Conditions: Neuromuscular monitoring; euromuscular blockadePediatric intensive care unit; Neuromuscular blocking agents

• Registration Number: TCTR20240328002
• Lead Sponsor: Dr. Suvikrom Law

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-28
• Last Update Posted: 19 August 2024
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total daily cisatracurium dose From 7am to 7am the next day Total daily cisatracurium dose measured in mg with one decimal point

Secondary Outcome Measures

Name	Time	Method
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