BronchoscopyPhase 4NCT03613792
Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy
A Phase 4 study testing Remifentanil, Fentanyl and Midazolam in people with Bronchoscopy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Bronchoscopy
- What is being tested?
- Remifentanil, Fentanyl and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2023to Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18 years-old)
- Undergoing planned flexible bronchoscopy with dynamic maneuvers for Excessive Central Airway Collapse assessment at Beth Israel Deaconess Medical Center.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215
About this study
Official title: Remifentanil Plus Ketamine Versus Midazolam Plus Fentanyl for Dynamic Flexible Bronchoscopy: Randomized Double-blind Clinical Trial
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.
- Conditions
- Bronchoscopy
- Being tested
- Remifentanil, Fentanyl, Midazolam, Ketamine
- Keywords
- dynamic, flexible
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Opioid analgesic
FentanylDrug
Opioid analgesic
MidazolamDrug
Also called Versed
Benzodiazepine
KetamineDrug
Analgesic
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil and Ketamine Group | Active comparator | 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. Receives: Drug: Remifentanil; Drug: Ketamine |
| Fentanyl and Midazolam | Active comparator | 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 Receives: Drug: Fentanyl; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction with Sedation Instrument (PSSI)
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).
Measured: Two hours after procedure conclusion, prior to patient discharge from the hospital
Secondary outcomes (8)
Numerical Rating Scale (NRS) for Discomfort
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).
Measured: Two hours after procedure conclusion, prior to patient discharge from the hospital
ALDRETE score
The ALDRETE score (global assessment of post-anesthetic condition) is used to assess patients' recovery after bronchoscopy at PACU
Measured: Two hours after procedure conclusion, prior to patient discharge from the hospital
Clinician Satisfaction with Sedation Instrument (CSSI)
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).
Measured: Two hours after procedure conclusion, prior to patient discharge from the hospital
Severity of Cough
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
Measured: Two hours after procedure conclusion, prior to patient discharge from the hospital
Incidence of Complications
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.
Measured: Two hours after procedure conclusion, prior to patient discharge from the hospital
Duration of Dynamic Flexible Bronchoscopy
Defined as the total time spent between initial insertion of flexible bronchoscope and final withdrawal of such.
Measured: Two hours after procedure conclusion, prior to patient discharge from the hospital
PACU Length of Stay
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.
Measured: Until discharge from the PACU, on average one hour
Total Nebulized Lidocaine Dose
Total dose requirement of nebulized lidocaine, pain medication and cough suppressors at PACU discharge.
Measured: Until discharge from the PACU, on average one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study startSep 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Change in procedure means limited value for study question
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satya Krishna Ramachandran, Beth Israel Deaconess Medical Center
- Investigators
- Satya Krishna Ramachandran, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613792
- Sponsor's protocol ID
- 2018P000023
- Status last verified
- Jul 2023
- First submitted
- 30 Jul 2018
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanil Plus Ketamine Versus Midazolam Plus Fentanyl for Dynamic Flexible Bronchoscopy: Randomized Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT03613792
- Acronym / sponsor ID
- 2018P000023
- Conditions
- Bronchoscopy
- Keywords
- dynamic, flexible
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in procedure means limited value for study question
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil and Ketamine Group | Active comparator | Drug: Remifentanil, Drug: KetaminePatients 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. |
| Fentanyl and Midazolam | Active comparator | Drug: Fentanyl, Drug: MidazolamThe 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (>18 years-old)
- Undergoing planned flexible bronchoscopy with dynamic maneuvers for Excessive Central Airway Collapse assessment at Beth Israel Deaconess Medical Center.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifentanilOpioid analgesic | Drug | Remifentanil and Ketamine Group |
| FentanylOpioid analgesic | Drug | Fentanyl and Midazolam |
| MidazolamAlso: VersedBenzodiazepine | Drug | Fentanyl and Midazolam |
| KetamineAnalgesic | Drug | Remifentanil and Ketamine Group |
Primary outcome
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).
8 secondary outcomes
Numerical Rating Scale (NRS) for Discomfort
Time frame: Two hours after procedure conclusion, prior to patient discharge from the hospital
ALDRETE score
Time frame: Two hours after procedure conclusion, prior to patient discharge from the hospital
Clinician Satisfaction with Sedation Instrument (CSSI)
Time frame: Two hours after procedure conclusion, prior to patient discharge from the hospital
Severity of Cough
Time frame: Two hours after procedure conclusion, prior to patient discharge from the hospital
Incidence of Complications
Time frame: Two hours after procedure conclusion, prior to patient discharge from the hospital
Duration of Dynamic Flexible Bronchoscopy
Time frame: Two hours after procedure conclusion, prior to patient discharge from the hospital
PACU Length of Stay
Time frame: Until discharge from the PACU, on average one hour
Total Nebulized Lidocaine Dose
Time frame: Until discharge from the PACU, on average one hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Bronchoscopy
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Active, not recruitingObservational study
Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy
Postoperative Sore Throat, Bronchoscopy
RecruitingObservational study
Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study
Operator Radiation Exposure
Not yet recruiting
Postoperative Pulmonary Function Assessment Based on Deep Learning Study
Lung Cancer (NSCLC)
Not yet recruitingPhase 2
Navigation Bronchoscopy Guided Microwave Ablation Versus SBRT in Early NSCLC
Lung Cancer (NSCLC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satya Krishna Ramachandran, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil, Fentanyl and Midazolam in people with Bronchoscopy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction with Sedation Instrument (PSSI) (time frame: Two hours after procedure conclusion, prior to patient discharge from the hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.