Comparison of Propofol/Alfentanil With Propofol/Ketamine (KET-001)

• ClinicalTrials.gov Identifier: NCT02000206
• Recruitment Status: Unknown
• First Posted: December 4, 2013
• Last Update Posted: December 4, 2013
• Sponsor: Rabin Medical Center
• Information provided by (Responsible Party): Mordechai Kremer, Rabin Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lung Disease	Drug: Propofol; Drug: Ketamine; Drug: Alfentanil	Not Applicable

  Show Detailed Description

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Sedation for Flexible Fiberoptic Bronchoscopy: Comparison of Propofol/Alfentanil With Propofol/Ketamine
• Study Start Date: February 2014
• Estimated Primary Completion Date: September 2014
• Estimated Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: propofol + alfentanil; Patients from the Propofol / Alfentanil group will receive in addition: A loading dose of 10-15 mcg/kg Alfentanil + 0.4 mg/kg Propofol, 2 minutes prior to the beginning of the procedure.; Additional boluses of Propofol (aliquots of 10-50 mg) throughout the procedure if required	Drug: Propofol; Other Name: Diprivan; Drug: Alfentanil; Other Name: Alfenta
Active Comparator: propofol + ketamine; Patients from the Propofol / Ketamine group will receive in addition: 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.; Additional boluses of Propofol (aliquots of 10-50 mg) and/or Ketamine (aliquots of 5-25 mg) throughout the procedure if required.	Drug: Propofol; Other Name: Diprivan; Drug: Ketamine; Other Name: Ketalar

Outcome Measures

Primary Outcome Measures :

1. Percutaneous carbon dioxide tension [ Time Frame: Average expected time of 45 minutes ]
   Continuous measurements (record every 4 seconds). Throughout the duration of fiberoptic bronchoscopy - from the beginning of the procedure until 10 minutes after its termination.
2. oxygen saturation [ Time Frame: Average expected time of 45 minutes. ]
   Continuous measurements (record every 4 seconds). Throughout the duration of fiberoptic bronchoscopy - from the beginning of the procedure until 10 minutes after its termination.
3. heart rate [ Time Frame: Average expected time of 45 minutes ]
   Continuous measurements (record every 4 seconds). Throughout the duration of fiberoptic bronchoscopy - from the beginning of the procedure until 10 minutes after its termination.
4. Non-invasive blood pressure [ Time Frame: Average expected time of 45 minutes ]
   Every 5 minutes. Throughout the duration of fiberoptic bronchoscopy - from the beginning of the procedure until 10 minutes after its termination

Secondary Outcome Measures :

1. Oxygen supplementation [ Time Frame: Average expected time of 45 minutes ]

   Significant hypoxemia, defined as functional SpO2 of 90%, will be treated initially with a jaw thrust maneuver. If it lasts more than few seconds, a naso/oropharyngeal tube will be inserted or supplemental oxygen will be delivered via face mask at 10 L min-1.

   The percentage of patients who needed supplemental oxygen will be evaluated

2. Naso/oropharyngeal tube insertion [ Time Frame: Average expected time of 45 minutes ]

   Significant hypoxemia, defined as functional SpO2 of 90%, will be treated initially with jaw support. If it lasts more than few seconds, a naso/oropharyngeal tube will be inserted or supplemental oxygen will be delivered via face mask at 10 L min-1

   The percentage of patients who needed Naso/oropharyngeal tube insertion will be evaluated

3. A questionnaire evaluating pain and discomfort [ Time Frame: Ca. 30 minutes after the end of the procedure (average expected time of 60 minutes) ]
   A questionnaire evaluating pain and discomfort by Visual Analog Scale will be completed by the patient when awake after the procedure.(~30 minutes after the end of the procedure)
4. A questionnaire evaluating the quality of sedation [ Time Frame: Immediately after end of procedure (average expected time of 30 minutes) ]
   A questionnaire evaluating the quality of sedation and the ease of performing the procedure by Visual Analog Scale will be completed by the bronchoscopist immediately after the procedure.
5. Total propofol dosage [ Time Frame: Average expected time of 30 minutes ]
   The total amount of propofol used throughout the procedure will be calculated.
6. Time to full awakening and orientation [ Time Frame: Anticipated to be in the range of 1-30 minutes after the end of the procedure ]
   Time from termination of the procedure to full awakening and orientation
7. Time to discharge [ Time Frame: Average expected time of 60 minutes. Anticipated to be in the range of 45-120 minutes after the end of fiberoptic bronchoscopy ]
   The time from the termination of the procedure until the patient is discharged from the recovery unit will be measured.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: Yair Manevich, MD; yair.manevich@gmail.com

Locations

Israel

Pulmonary Institute, Rabin Medical Center, Beilinson Hospital

Petach Tikva, Israel, 49100

Sponsors and Collaborators

Rabin Medical Center

Investigators

• Study Director: Mordechai R Kramer, MD; Rabin Medical Center

More Information

Publications:

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.

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:i1-21.

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.

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.

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

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.

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.

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.

White PF, Way WL, Trevor AJ. Ketamine--its pharmacology and therapeutic uses. Anesthesiology. 1982 Feb;56(2):119-36.

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

Slonim AD, Ognibene FP. Amnestic agents in pediatric bronchoscopy. Chest. 1999 Dec;116(6):1802-8.

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.

• Responsible Party: Mordechai Kremer, Head of Pulmonary Institute, Rabin Medical Center
• ClinicalTrials.gov Identifier: NCT02000206 History of Changes
• Other Study ID Numbers: RMC13ctl
• First Posted: December 4, 2013
• Last Update Posted: December 4, 2013
• Last Verified: November 2013

Keywords provided by Mordechai Kremer, Rabin Medical Center:

Ketamine; Alfentanil; Propofol; Oxygen saturation; Percutaneous carbon dioxide; Bronchoscopy

Additional relevant MeSH terms:

Lung Diseases; Respiratory Tract Diseases; Ketamine; Alfentanil; Propofol; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Anesthetics, Dissociative; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Analgesics, Opioid; Narcotics