Sedation During Bronchoscopy:Dexmedetomidine vs Alfentanil

Bronchoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805726
• Other study ID #: FM235
• Status: Completed
• Phase: Phase 3
• First received: February 17, 2013
• Last updated: November 22, 2014
• Start date: February 2013
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Saint-Joseph University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: November 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchoscopy
• Conscious Sedation

Intervention

Drug:
• xylocain
Xylocain: (C): Local anesthesia 1% 25 ml in total (bronchoscopy) + saline serum
• Alfentanil
(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)
• Dexmedetomidine
(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)

Locations

Country	Name	City	State
Lebanon	Hotel Dieu de France Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tolerance of examination	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	During, at the end and one hour after the bronchoscopy.	Yes
Primary	Bronchoscopy score	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) Scale will be between: minimum 3 and maximum 16	At the end of the bronchoscopy procedure	Yes
Secondary	Level of 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. 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) "	At the end of the bronchoscopy procedure	Yes