DEXMEDETOMIDINA VERSUS PROPOFOL FOR SEDATION DURING ECOBRONCHOSCOPY

DEXMEDETOMIDINA VERSUS PROPOFOL FOR SEDATION DURING ECOBRONCHOSCOPY - DEXEBUS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001110-97-ES

Enrollment

Unknown

Registered

2015-04-27

Start date

2015-06-05

Completion date

Unknown

Last updated

2017-05-22

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

Conditions

Patients with suspicion of malignant pulmonary neoplasia who need an ecobronchoscopy under sedation

Interventions

Trade Name: Dexdor Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: DEXMEDETOMIDINE CAS Number: 113775-47-6 Concentration unit: µg/ml microgram(s)/millilitre Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients under 18 years Patients with suspicion of malignant pulmonary neoplasia who need an ecobronchoscopy under sedation Patients with signed informed consent 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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: Hypersensitivity to the active substance or to any of the included excipients Advanced heart block (grade 2 or 3) unless paced. Uncontrolled hypotension. Acute cerebrovascular conditions.

Design outcomes

Primary

Measure	Time frame
Main Objective: Incidence of desaturation with sedation with dexmedetomidine during ecobronchoscopic procedures;Secondary Objective: To evaluate if dexmedetomidina: 1/ Reduce the number of rescue airway maneuvers to avoid desaturation 2/ Maintain haemodynamic stability 3/ Achieve a good sedation level for the procedure 4/ Allow a short recovery time 5/ Reduce the dose of remifentanil and topical lidocaine 6/ Achieve a good bronchoscopist and patient satisfaction;Primary end point(s): To evaluate if dexmedetomidina reduce de incidence of desaturation (SpO2 ? 92%) compared with propofol during the ecobronchoscopy procedures.;Timepoint(s) of evaluation of this end point: Oxygen saturation will be recorded at T0, baseline; T1, after passage of the bronchoscope through vocal cords; T2, every 3 min after T1; T3, 10 min after the end of sedation; T4, at the time of patient discharge from the respiratory endoscopy unit.	—

Measure

Time frame

Main Objective: Incidence of desaturation with sedation with dexmedetomidine during ecobronchoscopic procedures;Secondary Objective: To evaluate if dexmedetomidina: 1/ Reduce the number of rescue airway maneuvers to avoid desaturation 2/ Maintain haemodynamic stability 3/ Achieve a good sedation level for the procedure 4/ Allow a short recovery time 5/ Reduce the dose of remifentanil and topical lidocaine 6/ Achieve a good bronchoscopist and patient satisfaction;Primary end point(s): To evaluate if dexmedetomidina reduce de incidence of desaturation (SpO2 ? 92%) compared with propofol during the ecobronchoscopy procedures.;Timepoint(s) of evaluation of this end point: Oxygen saturation will be recorded at T0, baseline; T1, after passage of the bronchoscope through vocal cords; T2, every 3 min after T1; T3, 10 min after the end of sedation; T4, at the time of patient discharge from the respiratory endoscopy unit.

—

Secondary

Measure	Time frame
Secondary end point(s): To evaluate if dexmedetomidina: 1/ Reduce the number of rescue airway maneuvers to avoid desaturation 2/ Maintain haemodynamic stability 3/ Achieve a good sedation level for the procedure 4/ Allow a short recovery time 5/ Reduce the dose of remifentanil and topical lidocaine 6/ Achieve a good bronchoscopist and patient satisfaction;Timepoint(s) of evaluation of this end point: 1/ Need for rescue airway manuevers during the whole procedure 2/ Heart rate, arterial pressure and presence of arrhythmias at T0, every 5 min from the start of sedation to the end of sedation and at the time of patient discharge from the respiratory endoscopy unit. 3/ Level of sedation after 15 min of the start of sedation, every 10 min during the procedure and at the time of patient discharge from the respiratory endoscopy unit. 4/ Recovery time mesured from the end of sedation to the complete concious recuperation 5/ Total dose of remifentanil and topical lidocaine at the end of the procedure 6/ Bronchoscopist satisfaction with the sedation at the end of the procedure. Patient satisfaction at the time of patient discharge from the respiratory endoscopy unit.	—

Measure

Time frame

Secondary end point(s): To evaluate if dexmedetomidina: 1/ Reduce the number of rescue airway maneuvers to avoid desaturation 2/ Maintain haemodynamic stability 3/ Achieve a good sedation level for the procedure 4/ Allow a short recovery time 5/ Reduce the dose of remifentanil and topical lidocaine 6/ Achieve a good bronchoscopist and patient satisfaction;Timepoint(s) of evaluation of this end point: 1/ Need for rescue airway manuevers during the whole procedure 2/ Heart rate, arterial pressure and presence of arrhythmias at T0, every 5 min from the start of sedation to the end of sedation and at the time of patient discharge from the respiratory endoscopy unit. 3/ Level of sedation after 15 min of the start of sedation, every 10 min during the procedure and at the time of patient discharge from the respiratory endoscopy unit. 4/ Recovery time mesured from the end of sedation to the complete concious recuperation 5/ Total dose of remifentanil and topical lidocaine at the end of the procedure 6/ Bronchoscopist satisfaction with the sedation at the end of the procedure. Patient satisfaction at the time of patient discharge from the respiratory endoscopy unit.

—

Countries

Spain

Contacts

Public ContactHuman Farmacology Research Group

Hospital del Mar Research Institute (IMIM)

Sbermejo@parcdesalutmar.cat003493248 33 55

Outcome results

None listed

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