Skip to content

Comparison of combined and general anesthesia for percutaneous dilation tracheostomy in patients with severe acute brain injury

Comparison of combined and general anesthesia for percutaneous dilation tracheostomy in patients with severe acute brain injury

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011243
Enrollment
44
Registered
2016-11-02
Start date
2016-11-02
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Anesthesia Percutaneous Dilation Tracheostomy S06 I61 I60

Interventions

Group 1: Combined opioid-free anesthesia: sodium thiopental 5 mg/kg bolus and 7 mg/kg/h infusion or in patients already on thiopental dose increase to 7 mg/kg/h
pipecuronium bromide 0,04-0,06 mg/kg
local anesthesia (upper laryngeal nerves, recurrent laryngeal nerves through cricothyroid membrane, surgical site infiltration) Group 2: Total intravenous anesthesia: sodium thiopental 5 mg/kg bolus a
fentanyl bolus 3-5 mkg/kg

Sponsors

Elizavetinskaya bolnitsa
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: intracranial injury, intracerebral hemorrhage, subarachnoid hemorrhage, severe acute brain injury (Glasgow Coma Scale on admission 3-8)

Exclusion criteria

Exclusion criteria: patients with bilateral fixed and dilated pupils, infusion of vasopressors or inotropic drugs at the moment of including, short cricosternal distance (less than 2,5 cm), coagulopathy (INR>1,5; APTT>55s; Fibrinogen<1,5g/l; platelets count < 100 pl/mkl ),chronic cardiovascular diseases (coronary artery disease, history of myocardial infarction, congestive heart failure, atrial fibrillation, a history (more than 1 month) of antihypertensive and antiarrhythmic drugs intake)

Design outcomes

Primary

MeasureTime frame
stress-response [time frame: from endotracheal tube positioning till tracheostomy tube is inserted] combined end-point: mean-arterial blood pressure or heart rate rise more than 20% from baseline (mean-arterial blood pressure and heart rate after anesthesia induction but before endotracheal tube positioning)

Secondary

MeasureTime frame
- arterial blood pressure rise [time frame: from endotracheal tube positioning till tracheostomy tube is inserted] arterial blood pressure (measured non-invasively with 2 minutes interval) rise proportion - heart rate rise [time frame: from endotracheal tube positioning till tracheostomy tube is inserted] heart rate (measured continuously) rise proportion - arterial blood pressure fall[time frame: from anesthesia induction till the start of an endotracheal tube positioning] arterial blood pressure (measured non-invasively with 2 minutes interval) rise proportion - anesthesia time [time frame: from thiopental bolus or speed rise till tracheostomy tube is inserted] anesthesia time measured in seconds within time frame - lidocain systemic toxicity [time frame: from lidocain injection till tracheostomy tube is inserted] lidocain systemic toxicity signes including abrupt blood pressure fall, arrhythmia (bradycardia, extrasystolia), seizures

Countries

Russia

Contacts

Public ContactDmitry Averyanov

Russian Military Medical Academy

averyanov@anesthvmeda.ru+79213863511

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026