Sedation During Bronchoscopy:Dexmedetomidine vs Alfentanil

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

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.

Study Overview

• Status: Completed
• Conditions: Bronchoscopy; Conscious Sedation
• Intervention / Treatment: Drug: xylocain; Drug: Alfentanil; Drug: Dexmedetomidine

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

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Phase 3

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Hotel Dieu de France Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Xylocain (C); (C): Local anesthesia	Drug: xylocain; Xylocain: (C): Local anesthesia 1% 25 ml in total (bronchoscopy) + saline serum; Other Names: Xylocain only
Active Comparator: Alfentanil Group + Xylocain (A); Local anesthesia and Alfentanil	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); Other Names: Alfentanil as morphinics short acting
Active Comparator: Dexmedetomidine Group + Xylocain (D); Local anesthesia and dexmedetomidine	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); Other Names: Dexmedetomidine as awake sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Saint-Joseph University
• Investigators: Principal Investigator: Moussa A Riachy, MD, FCCP, Saint-Joseph University

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: February 17, 2013
• First Submitted That Met QC Criteria: March 4, 2013
• First Posted (Estimate): March 6, 2013

Study Record Updates

• Last Update Posted (Estimate): November 25, 2014
• Last Update Submitted That Met QC Criteria: November 22, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: bronchoscopy; dexmedetomidine; sedation; pulmonary function; tolerance; alfentanil; xylocain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Dexmedetomidine; Alfentanil
• Other Study ID Numbers: FM235