Use of Ketamine for Conscious Sedation in Flexible Bronchoscopy

NCT06181188 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: C.2019.050
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators plan to conduct a single blinded randomized controlled trial in the Pulmonary Service to demonstrate the efficacy of ketamine and its utility in moderate sedation. Patients presenting for bronchoscopy who meet inclusion criteria will be approached, and if amenable, will be consented and enrolled. Patients will be randomized to receive either 1 mg of midazolam and ketamine 0.25 to 0.5 mg/kg loading dose with subsequent doses of 10-20 mg IV or standard fentanyl and midazolam in 25mcg and 1mg increments respectively for moderate sedation during their procedure. The primary outcome will be patient satisfaction, which will be measured a using patient clinical satisfaction form. A number of secondary outcomes will include the following: (1) provider satisfaction (2) the time from sedation administration to procedure start (when the scope is inserted), (3) the time from sedation to scope removal from the trachea (4) the time from sedation to discharge (defined as the time from the end of the procedure until the patient meets discharge criteria from the recovery area), (5) total dose of medications given (including midazolam, fentanyl, and ketamine), (6) adverse events, (7) vital signs, (8) and the need for additional medications, in particular reversal agents.

Conditions

Conscious Sedation; Patient Satisfaction; Ketamine

Keywords

Conscious Sedation; Bronchoscopy; Ketamine

Outcome Measures

Primary Outcomes (2)

• Patient sedation satisfaction with sedation instrument

  A twenty one question survey assessing patient satisfaction using a 7-point Likert Scale. A "1" on the scale would indicated very satisfied, 2 - satisfied, 3 - somewhat satisfied, 4 - neither satisfied nor dissatisfied, 5 - somewhat dissatisfied, 6 - dissatisfied, and 7- very dissatisfied.

  A survey will be conducted upon the completion of the procedure.

• Patient sedation satisfaction with sedation instrument

  A twenty one question survey assessing patient satisfaction using a 7-point Likert Scale. A "1" on the scale would indicated very satisfied, 2 - satisfied, 3 - somewhat satisfied, 4 - neither satisfied nor dissatisfied, 5 - somewhat dissatisfied, 6 - dissatisfied, and 7- very dissatisfied.

  A follow up survey will be conducted 24-48 hours after the completion of the bronchoscopy. The average of both survey's will then be used to score the overall satisfaction of sedation.

Secondary Outcomes (10)

• Clinician satisfaction with sedation instrument

  Upon completion of the procedure

• time from sedation administration to procedure start

  during the procedure

• procedural time

  during the procedure

• Total time

  during the procedure

• Total dose of medications given

  during the procedure

Other Outcomes (3)

• A patient's history of alcohol consumption.

  at enrollment and during the procedure

• A patient's history of chronic opioid use.

  at enrollment and during the procedure

• A patient's history of chronic benzodiazepine use.

  at enrollment and during the procedure

Study Arms (2)

Ketamine and Midazolam

EXPERIMENTAL

Patients will receive 1mg of midazolam and a bolus of 0.25 - 0.5mg/kg of ketamine to initiate sedation. Additional 10-20mg of ketamine will be given every 3-5 minutes to achieve adequate sedation. If additional anxiolysis is needed, additional doses of midazolam will be given every 3-5 minutes in 1mg increments. .

Drug: Ketamine; Drug: Midazolam

Midazolam and Fentanyl

ACTIVE COMPARATOR

Patient will receive midazolam and fentanyl in 1mg and 25mcg increments respectively until adequate procedural sedation is achieved. Additional increments will be given every 3-5 minutes as needed to achieve adequate sedation.

Drug: Midazolam; Drug: Fentanyl

Interventions

Ketamine DRUG

Patients will receive a combination of ketamine and midazolam for conscious sedation

Also known as: Ketalar

Ketamine and Midazolam

Midazolam DRUG

Patients will receive 1mg of midazolam regardless of which arm they are in and my be given 1mg doses for added sedation as needed every 3-5 minutes

Also known as: Versed

Ketamine and Midazolam; Midazolam and Fentanyl

Fentanyl DRUG

Patients randomized to the midazolam and fentanyl arm will receive 25mcg incremental doses for procedural sedation

Midazolam and Fentanyl

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18 to 75 years who present to the pulmonary clinic for bronchoscopy and considered for airway survey, transbronchial biopsy, endobronchial biopsy, or bronchoalveolar lavage.
• Provider performing the bronchoscopy

You may not qualify if:

• Systolic blood pressure over 180mmHg and/or diastolic blood pressure over 110 on two consecutive readings
• Tachycardia greater than 120 beats/minute on two consecutive measurements
• Any allergy to ketamine, fentanyl, or midazolam
• Patient is pregnant or refuses pregnancy test,in women of child-bearing potential\*
• American Society of Anesthesiologists (ASA) score \> 3
• Presence of a history of psychosis, hallucinations, and/or a psychotic disorder

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Ketamine; Midazolam; Fentanyl

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jess Anderson, DO

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Envelops with pre-randomized and documents will be sealed and placed in a locked cabinet. Once a patient has been enrolled an envelop will be obtained indicating which arm the patient will be enrolled into. The study drugs will be labeled A (ketamine), B (midazolam), and C (fentanyl) and will be referred to as A, B, or C during the procedure to as to maintain anonymity from the patient.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary & Critical Care Fellow

Model Details: Single blinded randomized control trial. The control arm will receive a combination of midazolam and fentanyl. The study arm will receive a combination of midazolam and ketamine.

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 26, 2023
• Study Start: July 15, 2019
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)