MedTrace Logo

Sedation During Bronchoscopy:Dexmedetomidine vs Alfentanil

NCT01805726 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2014-11-25

No results posted yet for this study

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.

Conditions

  • Bronchoscopy
  • Conscious Sedation

Interventions

DRUG

xylocain

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

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)

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)

Sponsors & Collaborators

  • Saint-Joseph University

    lead OTHER

Principal Investigators

  • Moussa A Riachy, MD, FCCP · Saint-Joseph University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-03-31
Completion
2014-11-30

Countries

  • Lebanon

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01805726 on ClinicalTrials.gov