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Local analgesia using the subglottic secretion drainage port in intubated patients: a single-centre cluster randomised controlled trial.

Effects of local anesthesia via the subglottic secretion drainage port on the trachea in patients with endotracheal Intubation: a single-center cluster randomized controlled trial.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052250085
Enrollment
108
Registered
2025-08-06
Start date
2025-10-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

N/A Intensive care unit, Critical care, Ventilators, Mechanical

Interventions

Group A: 2 ml of 2% lidocaine administered over the cuff every 6 hours for 24 hours (160 mg/24 hours) Group B: 4 ml of 4% lidocaine administered over the cuff every 6 hours for 24 hours (640 mg/24 ho
Anesthesia, Local
Lidocaine, Pain Management

Sponsors

Homma Hiroshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Intubated patients in ICU, CCU, EICU Patients Patients aged between 18 and 85 years Patients with CPOT 2 or more Patients for whom consent has been obtained.

Exclusion criteria

Exclusion criteria: Patients with GCS 8 or less Patients who are expected to be extubated within 24 hours. Patients who have been previously enrolled in this study Patients with a known allergy to lidocaine Patients who need to be arrested, detained, detained, or confined by investigative or legal authorities Patients participating in clinical research involving other therapeutic interventions within the last three months Patients whose participation in the study is deemed inappropriate by the clinician

Design outcomes

Primary

MeasureTime frame
Absolute value of the CPOT score, 30 minutes after the start of the intervention.

Secondary

MeasureTime frame
CPOT scores at 2, 4 and 6 hours after the start of the intervention Dose of drugs used for analgesia and sedation at 24 hours after the start of the intervention Onset of delirium up to 72 hours after the start of the intervention Ventilator-associated pneumonia (VAP) up to 7 days after the end of the intervention Ventilator free days at 28 days from the start of the intervention Lidocaine concentration in blood 15-30 minutes after the last intervention (at 18 hours). Percentage of lidocaine intoxication during the intervention.

Contacts

Public ContactKeiichiro Shimoyama

Tokyo Medical University Hospital

shimoyan@tokyo-med.ac.jp+81-3-3342-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026