NCT01805726

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. 1.\- Group standard/control: local anesthesia only(C)
  2. 2.\- Group alfentanil + local anesthesia(A)
  3. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2013

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

28 days

First QC Date

February 17, 2013

Last Update Submit

November 22, 2014

Conditions

BronchoscopyConscious Sedation

Keywords

bronchoscopysedationpulmonary functiontolerancexylocaindexmedetomidinealfentanil

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Level of sedation for bronchoscopy

    At the end of the bronchoscopy procedure

Other Outcomes (1)

  • Tolerance of examination

    During, at the end and one hour after the bronchoscopy.

Study Arms (3)

Xylocain (C)

PLACEBO COMPARATOR

(C): Local anesthesia

Drug: xylocain

Alfentanil Group + Xylocain (A)

ACTIVE COMPARATOR

Local anesthesia and Alfentanil

Drug: Alfentanil

Dexmedetomidine Group + Xylocain (D)

ACTIVE COMPARATOR

Local anesthesia and dexmedetomidine

Drug: Dexmedetomidine

Interventions

xylocainDRUG

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

Also known as: Xylocain only
Xylocain (C)
AlfentanilDRUG

(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)

Also known as: Alfentanil as morphinics short acting
Alfentanil Group + Xylocain (A)
DexmedetomidineDRUG

(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)

Also known as: Dexmedetomidine as awake sedation
Dexmedetomidine Group + Xylocain (D)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu de France Hospital

Beirut, Lebanon

Location

MeSH Terms

Interventions

AlfentanilDexmedetomidine

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImidazolesAzoles

Study Officials

  • Moussa A Riachy, MD, FCCP

    Saint-Joseph University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2013

First Posted

March 6, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2013

Study Completion

November 1, 2014

Last Updated

November 25, 2014

Record last verified: 2014-11

Locations

LE(1)