Use of Ketamine for Conscious Sedation in Flexible Bronchoscopy
Condition: Conscious Sedation; Patient Satisfaction; Ketamine
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      The investigators propose to carry out a single blinded randomized controlled trial where 33
      patients will receive midazolam and ketamine for sedation in one arm and 33 will receive the
      standard fentanyl and midazolam combination in the other arm. During the procedure, the
      investigators will measure and record vital signs as well as the total dose of medication
      used. After the procedure, the investigator will note the time to recovery and discharge. The
      bronchoscopist will be asked to assess the quality of the procedure as well as a checklist to
      the patient to be done immediately after the procedure and 48 hours post procedure.

      A patient presents to the pulmonary clinic for a scheduled outpatient bronchoscopy. During
      the initial visit to discuss the need for bronchoscopy, patients will be provided with a
      brochure on the study and advised that if they meet inclusion criteria, they may elect to
      participate. If the patient elects to participate in the study and meets inclusion and
      exclusion criteria they will be consented and enrolled. Once enrolled, the study personnel
      will then retrieve the subject's assigned envelope that will contain all the data collection
      forms and the study medication will be ordered. If the patient is enrolled in the ketamine
      arm, an order for ketamine will be placed in in the electronic medical record to the
      inpatient OR pharmacy for 10mg/ml (10ml) prefilled syringe. Pulmonary clinic nursing
      personnel will pick up the ketamine syringe from inpatient OR pharmacy. In the Bronchoscopy
      Suite, nurse will affix a sticker "Drug A" to cover the ketamine 10mg/mL pharmacy label. The
      remainder of the medications will be pulled from the pyxis machine in the bronchoscopy suite
      and kept on standby by the bedside nurse.

      Once consented, the nurse or physician taking care of the patient will then take the sealed
      envelope within the packet containing the subject's randomized medication assignment and give
      this sealed envelope to the nurse involved in the subject's care to retrieve the medication.
      To maintain the study protocol the ketamine syringe will be labeled as 'drug A" The bedside
      nurse will label the syringe with midazolam and fentanyl as "drug B and drug C" respectively
      along with the amount, the patient name and the initial of the preparer, then give the
      medications to the attending physician for verification and administration by either the
      attending physician or fellow physician under direct supervision of the attending physician.
      The patient will be blinded to the study medication but the physicians and nursing staff will
      know the identity of the medications being administered. The subject will continue on with
      care as directed by the provider. There will be at least two licensed providers in the room
      for the duration of the procedure.

      In regards to quality of sedation, procedural sedation will be titrated to achieve a RASS
      score of negative 1 to negative 3. In the patient's randomized to the ketamine arm they will
      receive an initial 1mg dose of IV midazolam for anxiolysis followed by Ketamine at an initial
      dose of 0.25 - 0.5 mg/kg administered over 1 minute. Additional doses of ketamine 10-20mg
      will be administered every 5-10 minutes until an appropriate level of sedation is achieved.
      Additional midazolam can be given for anxiety at the discretion of the attending physician.
      If the procedure calls for fentanyl to be used instead of ketamine, midazolam will be given
      in 1mg and fentanyl in 25mcg increments every 3 minutes and titrated to achieve a RASS of -3.
      During the procedure, the physician and nursing staff will refer to ketamine as "A" and then
      the dose (e.g. "please administer 10 mg of A") and midazolam as "B" in order to prevent the
      subject from knowing the identity of the study medication. If the bronchoscopist does not
      feel adequate sedation has been achieved after several doses of ketamine (at least 4 doses),
      they may convert the procedure to standard sedation consisting of fentanyl and midazolam and
      drop the subject from the study. Additionally, if the procedure is started and it is
      determined that the patient cannot be adequately sedated then the physician can elect to
      abort the procedure and drop the subject from the study. After completion of the procedure,
      the bronchoscopist will be given a form in which to rate the quality of procedural sedation;
      attached for review. During the procedure, vital signs and medication dose administration
      data will be recorded on the medication use sheet as already used in the BAMC pulmonary
      suite. Following the procedure, all immediate complications during the procedure will be
      recorded.

      The investigator will record the time elapsed from medication administration until discharge
      from the recovery area. Subjects will be discharged from the recovery area after they meet
      preset parameters found in the standard operating procedures of the bronchoscopy suite.
      Procedural times such start time, completion of procedure, and total dose of sedation will be
      documented in the procedural report as currently preformed for all bronchoscopies. The total
      dose of sedation will be added to the procedural report by a study team member after the
      physician has filled out the report and submitted their sedation checklists as detailed below
      in order to maintain proper blinding. Immediately following the procedure, the bronchoscopist
      will complete a form rating: the overall quality of sedation, rating of subject discomfort,
      sedation-related technical difficulties, and depth of sedation. It will also me noted on the
      data recording form if the patient has an active prescription for opioids, benzodiazepines,
      or if they consume greater than or equal to five alcohol drinks per week.

      After the subject meets the preset parameters found in the standard operating procedures of
      the bronchoscopy suite for discharge, a post-procedural checklists will be administered and
      the subject will be discharged home. The subject will be contacted via phone 48 hours after
      the procedure and will be asked to rate the quality of the procedure via the modified PSSI
      index as well as additional questions about their oral intake and if they experienced any
      side effects specific to ketamine. A sample of the script for the post-procedural phone call
      will be attached for review. The investigator will attempt to contact each subject at least
      3x starting 48 hours after the procedure for two more days. voicemails will be left after
      each attempt. If they are unreachable, they will then be noted as lost to follow up.

      All checklists will be sealed into separate envelopes and will be placed in the subject's
      overall study envelope. The envelopes will remain sealed until the study results are
      analyzed.
    

Intervention name(s): Ketamine; Midazolam; Fentanyl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive a combination of ketamine and midazolam for conscious sedation; 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; Patients randomized to the midazolam and fentanyl arm will receive 25mcg incremental doses for procedural sedation
Other intervention name(s): Ketalar; Versed
Intervention MeSH terms: Midazolam; Fentanyl; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Conscious Sedation; Bronchoscopy; Ketamine