NCT02000206

Brief Summary

A prospective, randomized, patient-blinded comparison of the safety and efficacy of conscious sedation by propofol/alfentanil with propofol/ketamine in patients undergoing flexible fiberoptic bronchoscopy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 23, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 4, 2013

Status Verified

November 1, 2013

Enrollment Period

7 months

First QC Date

October 23, 2013

Last Update Submit

November 26, 2013

Conditions

Lung Disease

Keywords

KetamineAlfentanilPropofolOxygen saturationPercutaneous carbon dioxideBronchoscopy

Outcome Measures

Primary Outcomes (4)

  • Percutaneous carbon dioxide tension

    Continuous measurements (record every 4 seconds). Throughout the duration of fiberoptic bronchoscopy - from the beginning of the procedure until 10 minutes after its termination.

    Average expected time of 45 minutes

  • oxygen saturation

    Continuous measurements (record every 4 seconds). Throughout the duration of fiberoptic bronchoscopy - from the beginning of the procedure until 10 minutes after its termination.

    Average expected time of 45 minutes.

  • heart rate

    Continuous measurements (record every 4 seconds). Throughout the duration of fiberoptic bronchoscopy - from the beginning of the procedure until 10 minutes after its termination.

    Average expected time of 45 minutes

  • Non-invasive blood pressure

    Every 5 minutes. Throughout the duration of fiberoptic bronchoscopy - from the beginning of the procedure until 10 minutes after its termination

    Average expected time of 45 minutes

Secondary Outcomes (7)

  • Oxygen supplementation

    Average expected time of 45 minutes

  • Naso/oropharyngeal tube insertion

    Average expected time of 45 minutes

  • A questionnaire evaluating pain and discomfort

    Ca. 30 minutes after the end of the procedure (average expected time of 60 minutes)

  • A questionnaire evaluating the quality of sedation

    Immediately after end of procedure (average expected time of 30 minutes)

  • Total propofol dosage

    Average expected time of 30 minutes

  • +2 more secondary outcomes

Study Arms (2)

propofol + alfentanil

ACTIVE COMPARATOR

Patients from the Propofol / Alfentanil group will receive in addition: 1. A loading dose of 10-15 mcg/kg Alfentanil + 0.4 mg/kg Propofol, 2 minutes prior to the beginning of the procedure. 2. Additional boluses of Propofol (aliquots of 10-50 mg) throughout the procedure if required

Drug: PropofolDrug: Alfentanil

propofol + ketamine

ACTIVE COMPARATOR

Patients from the Propofol / Ketamine group will receive in addition: 1. A loading dose of 0.2-0.3 mg/kg Ketamine + 0.4 mg/kg Propofol, 2 minutes prior to the beginning of the procedure. 2. Additional boluses of Propofol (aliquots of 10-50 mg) and/or Ketamine (aliquots of 5-25 mg) throughout the procedure if required.

Drug: PropofolDrug: Ketamine

Interventions

PropofolDRUG
Also known as: Diprivan
propofol + alfentanilpropofol + ketamine
KetamineDRUG
Also known as: Ketalar
propofol + ketamine
AlfentanilDRUG
Also known as: Alfenta
propofol + alfentanil

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologists grade I or II
  • patients that will be referred to the procedure for bronchoalveolar lavage and cytologic/bacteriologic sampling, endoluminal biopsies for pathologic /bacteriologic analysis, or for regaining patency (mechanically or laser-assisted) of airways that are obstructed by secretions, tumors or foreign bodies

You may not qualify if:

  • patient refusal or inability to provide informed consent
  • American Society of Anesthesiologists grade III or higher
  • allergy to study medications
  • patients who have an endotracheal tube or tracheostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary Institute, Rabin Medical Center, Beilinson Hospital

Petah Tikva, 49100, Israel

Location

Related Publications (12)

  • Stolz D, Chhajed PN, Leuppi JD, Brutsche M, Pflimlin E, Tamm M. Cough suppression during flexible bronchoscopy using combined sedation with midazolam and hydrocodone: a randomised, double blind, placebo controlled trial. Thorax. 2004 Sep;59(9):773-6. doi: 10.1136/thx.2003.019836.

    PMID: 15333854BACKGROUND

  • British Thoracic Society Bronchoscopy Guidelines Committee, a Subcommittee of Standards of Care Committee of British Thoracic Society. British Thoracic Society guidelines on diagnostic flexible bronchoscopy. Thorax. 2001 Mar;56 Suppl 1(Suppl 1):i1-21. doi: 10.1136/thorax.56.suppl_1.i1. No abstract available.

    PMID: 11158709BACKGROUND

  • Gonzalez R, De-La-Rosa-Ramirez I, Maldonado-Hernandez A, Dominguez-Cherit G. Should patients undergoing a bronchoscopy be sedated? Acta Anaesthesiol Scand. 2003 Apr;47(4):411-5. doi: 10.1034/j.1399-6576.2003.00061.x.

    PMID: 12694138BACKGROUND

  • Fox BD, Krylov Y, Leon P, Ben-Zvi I, Peled N, Shitrit D, Kramer MR. Benzodiazepine and opioid sedation attenuate the sympathetic response to fiberoptic bronchoscopy. Prophylactic labetalol gave no additional benefit. Results of a randomized double-blind placebo-controlled study. Respir Med. 2008 Jul;102(7):978-83. doi: 10.1016/j.rmed.2008.02.011. Epub 2008 Apr 3.

    PMID: 18394874BACKGROUND

  • Putinati S, Ballerin L, Corbetta L, Trevisani L, Potena A. Patient satisfaction with conscious sedation for bronchoscopy. Chest. 1999 May;115(5):1437-40. doi: 10.1378/chest.115.5.1437.

    PMID: 10334165BACKGROUND

  • Stolz D, Kurer G, Meyer A, Chhajed PN, Pflimlin E, Strobel W, Tamm M. Propofol versus combined sedation in flexible bronchoscopy: a randomised non-inferiority trial. Eur Respir J. 2009 Nov;34(5):1024-30. doi: 10.1183/09031936.00180808. Epub 2009 Apr 22.

    PMID: 19386684BACKGROUND

  • Clark G, Licker M, Younossian AB, Soccal PM, Frey JG, Rochat T, Diaper J, Bridevaux PO, Tschopp JM. Titrated sedation with propofol or midazolam for flexible bronchoscopy: a randomised trial. Eur Respir J. 2009 Dec;34(6):1277-83. doi: 10.1183/09031936.00142108. Epub 2009 May 14.

    PMID: 19443532BACKGROUND

  • Crawford M, Pollock J, Anderson K, Glavin RJ, MacIntyre D, Vernon D. Comparison of midazolam with propofol for sedation in outpatient bronchoscopy. Br J Anaesth. 1993 Apr;70(4):419-22. doi: 10.1093/bja/70.4.419.

    PMID: 8499201BACKGROUND

  • White PF, Way WL, Trevor AJ. Ketamine--its pharmacology and therapeutic uses. Anesthesiology. 1982 Feb;56(2):119-36. doi: 10.1097/00000542-198202000-00007. No abstract available.

    PMID: 6892475BACKGROUND

  • Berkenbosch JW, Graff GR, Stark JM. Safety and efficacy of ketamine sedation for infant flexible fiberoptic bronchoscopy. Chest. 2004 Mar;125(3):1132-7. doi: 10.1378/chest.125.3.1132.

    PMID: 15006978BACKGROUND

  • Slonim AD, Ognibene FP. Amnestic agents in pediatric bronchoscopy. Chest. 1999 Dec;116(6):1802-8. doi: 10.1378/chest.116.6.1802.

    PMID: 10593809BACKGROUND

  • Hwang J, Jeon Y, Park HP, Lim YJ, Oh YS. Comparison of alfetanil and ketamine in combination with propofol for patient-controlled sedation during fiberoptic bronchoscopy. Acta Anaesthesiol Scand. 2005 Oct;49(9):1334-8. doi: 10.1111/j.1399-6576.2005.00842.x.

    PMID: 16146472BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Interventions

PropofolKetamineAlfentanil

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicFentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mordechai R Kramer, MD

    Rabin Medical Center

    STUDY DIRECTOR

Central Study Contacts

Yair Manevich, MD

CONTACT

yair.manevich@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pulmonary Institute

Study Record Dates

First Submitted

October 23, 2013

First Posted

December 4, 2013

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

December 4, 2013

Record last verified: 2013-11

Locations

IL(1)