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Sedation During Bronchoscopy:Dexmedetomidine vs Alfentanil

Success of Sedation During Bronchoscopy: Comparison of the Effects of Dexmedetomidine, Alfentanil and Local Anesthesia

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01805726
Enrollment
162
Registered
2013-03-06
Start date
2013-02-28
Completion date
2014-11-30
Last updated
2014-11-25

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

Conditions

Bronchoscopy, Conscious Sedation

Keywords

bronchoscopy, sedation, pulmonary function, tolerance, xylocain, dexmedetomidine, alfentanil

Brief summary

The purpose of this study is to find the best sedation necessary for patients undergoing bronchoscopy. Patients are randomized to three different regimes of sedation during bronchoscopy were studied: 1. \- Group standard/control: local anesthesia only(C) 2. \- Group alfentanil + local anesthesia(A) 3. \- Group dexmedetomidine + local anesthesia(D) The primary endpoint is the bronchoscopy score. Secondary endpoints are: Level of sedation and tolerance bronchoscopy examination. Measured parameters on the safety of examination are: the lowest saturation, needs to supplemental oxygen, amnesia , choking sensation or chest pain and if the patient is ready or not to undertake bronchoscopy second time in his life if necessary. Endtidal CO2, Respiratory rate, Blood pressure, Heart rate, level of oxygen are collected every 5 minutes before, during and after the bronchoscopy.

Detailed description

BACKGROUND: 1. Problem: The endoscopy of the tracheobronchial tree by endoscopy is an act very common in the daily activity of pulmonologists. The indications for bronchoscopy are multiple and include infectious causes, tumor, systemic disease, foreign bodies and other indications. It can be diagnostic or therapeutic purposes. Bronchoscopy is an invasive but rarely, however, induced severe complications (respiratory failure, hemodynamic collapse, massive bleeding ...). However, tolerance to the examination varies significantly between patients \[1-3\]. Different signs and symptoms include desaturation, chest pain, choking sensation and cough. These effects are likely to alter patient comfort during the procedure and the quality of it. To further improve the tolerance operators have resorted to various techniques. A first step in improving the comfort is a good local anesthesia using spray or swab intra nasal base and lidocaine anesthesia of the airway (trachea, carina and bronchi) during the examination. The second step involves the use of intravenous sedation \[1, 3-14\]. 2. Background: Until now, there is no standardized protocol for the best product and the best dose to use for sedation of patients. Several studies have been done comparing different drug or drug combination in the benzodiazepine family, ketamine or morphine with varying results and not leading in most cases to allow conclusions to establish clear guidelines regarding the use or no sedation plus local anesthesia and sedation dose of this \[1, 3, 5, 8, 15\]. Especially, for fear of adverse effects of sedation on respiratory function, many pulmonologists far are a little hesitant about the administration of sedatives during bronchoscopy. Dexmedetomidine is a new molecule sedation which is approved for its sedative effect while holding a revival meeting described as awake sedation. \[12, 16-22\] DESCRIPTION: The aim of this randomized controlled trial was to evaluate the feasibility and safety of three different regimes of sedation during bronchoscopy: * Group standard / control (local anesthesia only): (C) * Group alfentanil (+ local anesthesia): (A) * Group dexmedetomidine (+ local anesthesia): (D) The primary endpoint is: 1. / Feasibility / tolerance of bronchoscopy by the score bronchoscopy which includes: * The movement of the vocal cords (4 levels) * Cough (4 levels) * Movement members (4 levels) Secondary objectives: 2. / level sedation for bronchoscopy: * Level of sedation achieved according to the objective using: Nursing Instrument for the Communication of Sedation (NICS) (7 levels). * Dose of midazolam necessary complementary in each group. Midazolam to give to the judgment of the operator (if necessary) is predetermined speed (1 mg each minute) to the level of sedation (-1) Level of sedation achieved according to the objective using: Nursing Instrument for the communication of Sedation (NICS). 3. / Tolerance examination: * During the procedure * At the end of the procedure * After 1 hour of the end of the examination

Interventions

Xylocain: (C): Local anesthesia 1% 25 ml in total (bronchoscopy) + saline serum

DRUGAlfentanil

(A) Local anesthesia 1% 25 ml in total (bronchoscopy) + saline serum (slow perfusion for 10 minutes) + alfentanil 10 mcg / kg (slow injection in 5 seconds)

DRUGDexmedetomidine

(D) Local anesthesia 1% 25 ml in total (bronchoscopy) + dexmedetomidine 0.5 mcg / kg (slow perfusion for 10 minutes) + 2 ml saline (slow injection for 5 seconds)

Sponsors

Saint-Joseph University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* All patients admitted for diagnostic flexible bronchoscopy in the endoscopy department

Exclusion criteria

* Bronchoscopy outside the endoscopy unit * Tracheal stenosis * SpO2 \<90% in the open air * Bradycardia \<55 per minute * Atrioventricular block * Heart failure known (EF \<40%) * Alcoholism (\> 5 drinks per week)

Design outcomes

Primary

MeasureTime frameDescription
Bronchoscopy scoreAt the end of the bronchoscopy procedureFeasibility / tolerance of bronchoscopy by the score bronchoscopy which includes: * The movement of the vocal cords (4 levels) * Cough (4 levels) * Movement members (4 levels) Scale will be between: minimum 3 and maximum 16

Secondary

MeasureTime frameDescription
Level of sedation for bronchoscopyAt the end of the bronchoscopy procedure* Level of sedation achieved according to the objective using: Nursing Instrument for the Communication of Sedation (NICS) (7 levels). * Dose of midazolam necessary complementary in each group. Dormicum to give to the judgment of the operator (if necessary) is predetermined speed (1 mg each minute) to the level of sedation (-1) Level of sedation achieved according to the objective using: Nursing Instrument for the communication of Sedation (NICS)

Other

MeasureTime frameDescription
Tolerance of examinationDuring, at the end and one hour after the bronchoscopy.Visual Analogic Scale from 0-10 to evaluate the tolerance of the procedure: * During the procedure * At the end of the procedure * After 1 hour of the end of the examination

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026