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Is Remifentanil better than Propofol in providing optimal conditions for an awake fibreoptic intubation? - Remifentanil Vs Propofol for awake fibreoptic intubation

Is Remifentanil better than Propofol in providing optimal conditions for an awake fibreoptic intubation? - Remifentanil Vs Propofol for awake fibreoptic intubation

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000877-23-GB
Enrollment
24
Registered
2005-03-11
Start date
2005-04-11
Completion date
Unknown
Last updated
2012-04-03

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

Conditions

Awake fibre optic intubation is an anaesthetic technique used to intubate patients with a difficult to manage airway. It s a procedure by which a tracheal tube is inserted in a patients trachea while the patient is awake. In fact, most patients are not totally awake but are more commonly sedated during this procedure. We want to compare the efficacy and safety of remifentanil with propofol for awake fibreoptic intubation.

Interventions

Trade Name: Propofol Product Name: Propofol Pharmaceutical Form: Emulsion for infusion INN or Proposed INN: propofol Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concent

Sponsors

Oxford Radcliffe Hospitals NHS trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient inclusion Criteria: * ASA I-III patients requiring awake fibre optic intubation. * ASA- American society of Anesthesologist's classification of a patients physical status Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient exclusion Criteria: Age ASA 3 Unstable ward observations( acutely ill) Inability to communicate effectively

Design outcomes

Primary

MeasureTime frame
Main Objective: Awake fibreoptic intubation is a technique which requires some form of sedation and/or analgesia to make it more acceptable to the patient.Both propofol a short acting intravenous anaesthetic drug and remifentanil, an intravenous opiate with some sedative properties are used in this context.The main aim of the study is to compare remifentanil target controlled infusion with propofol target controlled infusion for sedation and anxiolysis during an awake fibreoptic condition . This study is not designed to test a particular drug, rather to compare two drugs which are already in use for this purpose with the aim to test if one drug is better than the other for sedation of patients undergoing am awake fibre-optic intubation ;Secondary Objective: ;Primary end point(s): PATIENT SEDATION SCORING SYSTEM MODIFIED STEWARD SCORE CONSCIOUSNESS (0-4) 4-fully awake, eyes open, conversive 3-lightly asleep ,eyes open intermittently 2-eyes open on command 1-response to ear pinching 0-no response AIRWAY (0-4) 3-opens mouth, coughs on command 2-opens mouth, clear airway, weak cough 1-airway obstruction relieved by head extension 0-airway obstruction needing jaw retraction/oropharyngeal airway ACTIVITY( 0-3) 2-raising arm on command 1-non purposeful movement 0-no movement DISCOMFORT SCORE(0-3) 0-no discomfort 1-probable mild discomfort, no patient resistance 2-restless patient, minimal patient resistance 3-restless patient, severe patient resistance DIFFICULTIES DURING ENDOSCOPY SCORE (0-2) 0-absent 1-present but did not interfere with endoscopy 2-present and was hindrance to endoscopy

Countries

United Kingdom

Outcome results

None listed

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