Sedation during examination with bronchoscopy

Patient-controlled sedation with propofol versus combined sedation during bronchoscopy – a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005274-38-SE

Enrollment

300

Registered

2016-01-21

Start date

2016-03-10

Completion date

Unknown

Last updated

2017-11-13

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

Conditions

Diagnostic bronchoscopy for referred outpatients

Interventions

Pharmaceutical Form: Emulsion for injection/infusion INN or Proposed INN: Propofol CAS Number: 2078-54-8 Other descriptive name: PROPOFOL Pharmaceutical Form: Solution for injection INN or Proposed I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patient (=18 years) Planned bronchoscopic procedure with sedation in an outpatient setting The patient have after receiving information about the study given their signed informed consent to participate. Women of childbearing potential only if use of highly effective contraceptive. 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 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Known pregnancy or planning to be pregnant Known/suspected allergy or contraindication to any medication within the study. Functional disability in both hands which affect the possibility to operate the PCS device. Cognitive impairment, unwillingness or language difficulties resulting in difficulty to understand the meaning of participation in the study or to operate the PCS device.

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Day of bronchoscopy;Main Objective: We hypothesise that the use of propofol patient controlled sedation for outpatient bronchoscopy will be a safe and well accepted procedure by patients and bronchoscopists, and increase the amount of patients ready for discharge after two hours, compared with sedation using midazolam and morphine. ;Secondary Objective: We also hypothesize that patient characteristics affect the amount of propofol self-administered by the patient during patient controlled sedation. ;Primary end point(s): The primary endpoint is the amount of patients ready for discharge within 2 hours, according to the Post Anaesthetic Discharge Scoring System (PADSS) score, after outpatient bronchoscopy.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Day of bronchoscopy;Main Objective: We hypothesise that the use of propofol patient controlled sedation for outpatient bronchoscopy will be a safe and well accepted procedure by patients and bronchoscopists, and increase the amount of patients ready for discharge after two hours, compared with sedation using midazolam and morphine. ;Secondary Objective: We also hypothesize that patient characteristics affect the amount of propofol self-administered by the patient during patient controlled sedation. ;Primary end point(s): The primary endpoint is the amount of patients ready for discharge within 2 hours, according to the Post Anaesthetic Discharge Scoring System (PADSS) score, after outpatient bronchoscopy.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints; assessment of self-rated patient characteristics using questionaries’ (Sense of Coherence, Coping Strategies Questionnaire, Hospital Anxiety and Depression Scale) and recovery (Post-discharge Surgical Recovery Scale), patients’ satisfaction, bronchoscopist evaluation (perception of cough, bronchial secretion and acceptance of procedure), total dose given of topical anaesthetic, analgesia and sedation drugs. Safety variables; level of sedation, vital signs (arterial oxygen saturation, respiratory frequency, non-invasive blood pressure and heart rate) and interventions performed to maintain cardiovascular and respiratory stability. ;Timepoint(s) of evaluation of this end point: Day of bronchoscopy except for recovery which will be evaluated day after bronchoscopy	—

Measure

Time frame

Secondary end point(s): Secondary endpoints; assessment of self-rated patient characteristics using questionaries’ (Sense of Coherence, Coping Strategies Questionnaire, Hospital Anxiety and Depression Scale) and recovery (Post-discharge Surgical Recovery Scale), patients’ satisfaction, bronchoscopist evaluation (perception of cough, bronchial secretion and acceptance of procedure), total dose given of topical anaesthetic, analgesia and sedation drugs. Safety variables; level of sedation, vital signs (arterial oxygen saturation, respiratory frequency, non-invasive blood pressure and heart rate) and interventions performed to maintain cardiovascular and respiratory stability. ;Timepoint(s) of evaluation of this end point: Day of bronchoscopy except for recovery which will be evaluated day after bronchoscopy

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Countries

Sweden

Contacts

Public ContactUniversitetssjukhuset i Linköping

Region Östergötland

lena.nilsson@regionostergotland.se

Outcome results

None listed

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