Sedation During Bronchoscopy:Dexmedetomidine vs Alfentanil

NCT ID: NCT01805726

Last Updated: 2014-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-11-30

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

Conditions

Bronchoscopy; Conscious Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Xylocain (C)

(C): Local anesthesia

Group Type: PLACEBO_COMPARATOR

xylocain

Intervention Type: DRUG

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

Alfentanil Group + Xylocain (A)

Local anesthesia and Alfentanil

Group Type: ACTIVE_COMPARATOR

Alfentanil

Intervention Type: DRUG

(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 Group + Xylocain (D)

Local anesthesia and dexmedetomidine

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

(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)

Interventions

xylocain

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

Intervention Type: DRUG

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)

Intervention Type: DRUG

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)

Intervention Type: DRUG

Other Intervention Names

Xylocain only; Alfentanil as morphinics short acting; Dexmedetomidine as awake sedation

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint-Joseph University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moussa A Riachy, MD, FCCP

Role: PRINCIPAL_INVESTIGATOR

Saint-Joseph University

Locations

Hotel Dieu de France Hospital

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

FM235

Identifier Type: -

Identifier Source: org_study_id