Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy

• ClinicalTrials.gov Identifier: NCT03613792
• Recruitment Status: Unknown
• First Posted: August 3, 2018
• Last Update Posted: January 14, 2020
• Sponsor: Beth Israel Deaconess Medical Center
• Information provided by (Responsible Party): Satya Krishna Ramachandran, Beth Israel Deaconess Medical Center

Study Description

Brief Summary:

This randomized controlled pilot clinical trial will enroll patients undergoing dynamic flexible bronchoscopy will be randomized to receive one of the two anesthetic combinations described above. The study will determine if there is a difference when considering patient and physician and satisfaction when performing DFB. Also, safety and efficacy of the two pharmacological combinations (fentanyl + midazolam and remifentanil + ketamine) used will be evaluated.

Condition or disease	Intervention/treatment	Phase
Bronchoscopy	Drug: Remifentanil; Drug: Fentanyl; Drug: Midazolam; Drug: Ketamine	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Supportive Care
• Official Title: Remifentanil Plus Ketamine Versus Midazolam Plus Fentanyl for Dynamic Flexible Bronchoscopy: Randomized Double-blind Clinical Trial
• Estimated Study Start Date: September 1, 2020
• Estimated Primary Completion Date: December 31, 2020
• Estimated Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Remifentanil and Ketamine Group; Patients in Group 1 will receive remifentanil and ketamine. Remifentanil will be administered initially with a 1mcg/kg IV bolus followed by a continuous infusion, 0.1 to 0.15 mcg/kg/min IV (using ideal body weight) with titration to a maximum dose of 0.2 to 0.4 mcg/kg/min IV. Total dose of ketamine will be titrated from 10 to 40 mg, based on clinical judgment, and it will be recorded. Ketamine will be delivered using 2mL syringes, previously filled with ketamine in normal saline at a 10mg/mL concentration.	Drug: Remifentanil; Opioid analgesic; Drug: Ketamine; Analgesic
Active Comparator: Fentanyl and Midazolam; The patients in this group will receive fentanyl doses that range between 0.5 to 2 mcg/kg (25 - 50 mcg) IV bolus in combination with midazolam 1-5 mg bolus over at least 2 minutes as determined by attending anesthesiologist (not to exceed 2.5 mg / 2 min per package insert). Total dosing of fentanyl and midazolam may be titrated, based on clinical judgment, and it will be recorded. Maintenance, additional midazolam doses of 25% of total initial dose required to achieved desired sedation may be administered IV if additional sedation is considered necessary	Drug: Fentanyl; Opioid analgesic; Drug: Midazolam; Benzodiazepine; Other Name: Versed

Outcome Measures

Primary Outcome Measures :

1. Patient Satisfaction with Sedation Instrument (PSSI) [ Time Frame: Two hours after procedure conclusion, prior to patient discharge from the hospital ]
   The primary outcome will be a difference in patient satisfaction with sedation, as determined by a 5-point difference in the PSSI questionnaire. The total score will be assessed by summing the responses to each question. In the scale, 0 will denote no satisfaction (worst outcome) and 100 will represent the greatest possible satisfaction (best outcome).

Secondary Outcome Measures :

1. Numerical Rating Scale (NRS) for Discomfort [ Time Frame: Two hours after procedure conclusion, prior to patient discharge from the hospital ]
   Difference between both groups in terms of numerical rating scale (NRS) for discomfort associated with the procedure (as reported by the patient). In the scale, 0 will denote no discomfort (best outcome) and 5 will represent the greatest possible discomfort (worse outcome).
2. ALDRETE score [ Time Frame: Two hours after procedure conclusion, prior to patient discharge from the hospital ]
   The ALDRETE score (global assessment of post-anesthetic condition) is used to assess patients' recovery after bronchoscopy at PACU
3. Clinician Satisfaction with Sedation Instrument (CSSI) [ Time Frame: Two hours after procedure conclusion, prior to patient discharge from the hospital ]
   The total score will be assessed by summing the responses to each question. In the scale, 0 will denote no satisfaction (worst outcome) and 100 will represent the greatest possible satisfaction (best outcome).
4. Severity of Cough [ Time Frame: Two hours after procedure conclusion, prior to patient discharge from the hospital ]
   A scale to address severity of cough during the procedure will be used when the bronchoscope pass through the vocal cords and at the level of the proximal trachea, distal trachea and main bronchi. This scale has three categories: Mild, single coughs; Moderate, more than one episode of cough that last less than 5 seconds; and Severe, cough more than 5 seconds
5. Incidence of Complications [ Time Frame: Two hours after procedure conclusion, prior to patient discharge from the hospital ]
   Complications such as desaturation, hypotension, pain, nausea, bradycardia, need for artificial airway or mechanical ventilation and need to abort bronchoscopy will be documented. These will then be compared as percentage of complications.
6. Duration of Dynamic Flexible Bronchoscopy [ Time Frame: Two hours after procedure conclusion, prior to patient discharge from the hospital ]
   Defined as the total time spent between initial insertion of flexible bronchoscope and final withdrawal of such.
7. PACU Length of Stay [ Time Frame: Until discharge from the PACU, on average one hour ]
   Total time of PACU stay with each of the pharmacological combinations, defined as the period of time between initial PACU arrival and final home or floor discharge.
8. Total Nebulized Lidocaine Dose [ Time Frame: Until discharge from the PACU, on average one hour ]
   Total dose requirement of nebulized lidocaine, pain medication and cough suppressors at PACU discharge.

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion criteria:

• Adult (>18 years-old)
• Undergoing planned flexible bronchoscopy with dynamic maneuvers for Excessive Central Airway Collapse assessment at Beth Israel Deaconess Medical Center.

Exclusion criteria:

• Patients with any past medical history of disease that would put them at risk of receiving one of the four proposed medications. This includes, but it's not limited to, allergies, advanced stage kidney disease, congestive heart failure and non-controlled hypertension.
• With a known/documented history of opioid abuse at any point during life.
• PO2< 60 mmHg or SO2 <85% on room air during any of the encounters with physicians between the moment of initial screening and the procedure itself.
• PaCO2 >60 mmHg
• Planned additional procedure(s) requiring general anesthesia after the dynamic bronchoscopy.

Contacts and Locations

Contacts

Contact: Satya Krishna Ramachandran, MD; 617-667-5531; skrama@bidmc.harvard.edu

Locations

United States, Massachusetts

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, United States, 02215

Contact: Satya Krishna Ramachandran, MD

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

• Principal Investigator: Satya Krishna Ramachandran, MD; Beth Israel Deaconess Medical Center

More Information

• Responsible Party: Satya Krishna Ramachandran, Vice Chair of Quality and Safety, Associate Professor of Anaesthesia, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT03613792
• Other Study ID Numbers: 2018P000023
• First Posted: August 3, 2018
• Last Update Posted: January 14, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Satya Krishna Ramachandran, Beth Israel Deaconess Medical Center:

dynamic; flexible

Additional relevant MeSH terms:

Fentanyl; Midazolam; Ketamine; Remifentanil; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; GABA Modulators; GABA Agents