Lung DiseasesPhase 3NCT06185127
Dexmedetomidine-ketamine Combination Versus Fentanyl-midazolam During Bronchoscopy
A Phase 3 study testing Dexmedetomidine, Ketamine and Midazolam in people with Lung Diseases and Diagnosis, run by University of Patras at 1 site in Greece.
Trial summary
Sedation during flexible bronchoscopy (FB) should maintain an adequate respiratory drive, ensure maximum comfort for the patient, and warrant that the objectives of the procedure are achieved. Nevertheless, the optimal sedation method for FB has yet to be established. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Lung Diseases, Diagnosis, Anesthesia
- What is being tested?
- Dexmedetomidine, Ketamine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2019to 31 Aug 2020
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for flexible bronchoscopy at the Naval Hospital of Athens
- Written informed consent
Who cannot join
- known or suspected allergy to any of the study drugs
- renal impairment (serum creatinine > 2 mg/dL)
- hepatic impairment (liver enzymes > 2 times the upper limit of normal)
- seizure disorders
- history of psychosis or bipolar disorder
- hemodynamic instability (heart rate - HR < 50 bpm or systolic blood pressure - SBP < 90 mmHg)
- critically ill patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine-ketamine Combination Versus Fentanyl-midazolam for Patient Sedation During Flexible Bronchoscopy: a Prospective, Single-blind, Randomized Controlled Trial
Sedation during flexible bronchoscopy (FB) should maintain an adequate respiratory drive, ensure maximum comfort for the patient, and warrant that the objectives of the procedure are achieved. Nevertheless, the optimal sedation method for FB has yet to be established. This study aimed to compare the standard recommended combination of midazolam-fentanyl (MF) with that of dexmedetomidine-ketamine (DK) for patient sedation during FB. Patients subjected to FB were randomly assigned to a DK (n=25) and an MF group (n=25). The primary outcome was the rate of critical desaturation events (arterial oxygen saturation <80% with nasal oxygen supply 2 L/min). Secondary outcomes included sedation depth, hemodynamic complications, adverse events, and patient and bronchoscopist satisfaction.
Read the detailed description
Study design and population This randomized controlled trial of adult patients (age >18 years) scheduled for FB was conducted between September 2019 and May 2020 at the Respiratory Medicine Department of Athens Naval Hospital, Greece.
Exclusion criteria included: known or suspected allergy to any of the study drugs, renal impairment (serum creatinine > 2 mg/dL), hepatic impairment (liver enzymes > 2 times the upper limit of normal), seizure disorders, history of psychosis or bipolar disorder, hemodynamic instability (heart rate - HR < 50 bpm or systolic blood pressure - SBP < 90 mmHg), and critically ill patients. The study protocol was approved by the Ethics Committee of Athens Naval Hospital (act number 296/13.08.2019), and written informed consent was obtained from all participants.
Protocol Demographic data and medical history were reviewed at the presentation, and the vital signs were assessed and recorded.
Eligible patients were then randomly assigned to two groups:
- DK group: Dexmedetomidine solution of 1 μg/kg dissolved in 60 ml saline was administered over 15 minutes, followed by a maintenance dose of 0.5 μg/kg/h (continuous infusion). After the first 15 minutes, a bolus dose of 50 mg ketamine dissolved in 10 ml saline was given. An increase of 0.1 μg/kg in the infusion rate of dexmedetomidine was considered when necessary to optimize the level of sedation.
- MF group: Bolus doses of midazolam (5 mg midazolam dissolved in 10 ml saline; 2 ml of the solution or 1 mg midazolam per bolus, premedication dose of 2mg, induction dose of 2 mg) and fentanyl (100 μg / 10 ml; 5 ml of the solution or 50 μg fentanyl per bolus, induction dose of 50μg) were administered at 20-minute intervals in between and titrated as needed to obtain the desired sedation depth. No more than 12 mg of midazolam and 150 μg of fentanyl were administered.
The depth of sedation was quantified at the onset of drug infusion using the Observer's Assessment of Alertness/Sedation scale; a maximum score of 3 was considered optimal for starting FB. Bolus doses of dexmedetomidine (DK group) and midazolam (MF group) were administered when necessary to maintain the same target score. An anesthesiologist was present throughout the procedure to oversee and monitor the sedation protocol. Only the anesthesiologist and the nurse of the bronchoscopy suite were aware of the sedation regimen. The attending pulmonologist remained blind regarding the sedation protocol until the completion of the bronchoscopist satisfaction questionnaire (see below).
Lidocaine gel was placed at the nostril of entry before the procedure, and lidocaine (4 ml of 2% solution) was sprayed under direct vision through the bronchoscope for vocal cord anesthesia before entering the larynx. All participants (in both the MF and the DK group) were initially premedicated with 2 mg of midazolam for anxiolysis and perioperative amnesia 10 minutes before commencing the procedure. They also received oxygen at 2 L/min via nasal cannula and 0.9 NaCl i.v. at 8 ml/h throughout the procedure. Continuous monitoring included electrocardiography, oxygen saturation (SpO2), and automated non-invasive blood pressure recordings.
Outcomes The depth of sedation was evaluated using the Ramsay sedation scale [28] and the Riker sedation-agitation scale. Both tools provide quantitative measurements in the maximum and minimum sedation-agitation range during the procedure. Higher Ramsay and lower Riker scores signify deeper sedation levels.
Bronchoscopist satisfaction was measured with a Likert-scale tool answering the question "How satisfied are you with both the ease and outcome of the procedure?" as follows: 1 = not satisfied at all; 2 = somewhat satisfied; 3 = more satisfied with the procedural outcome; 4 = mostly satisfied with the outcome and somewhat with procedural ease; 5 = exceptionally satisfied with both procedural outcome and ease.
Patient satisfaction was evaluated by a short, custom-made questionnaire that included the following questions: 1) I was satisfied with the sedation administered for the procedure, 2) I felt pain and/or discomfort beyond my tolerance during the procedure, 3) I believe my needs were met during the procedure 4) I felt pain and discomfort after the procedure, 5) I would be willing to undergo a second procedure if the first did not yield adequate results. The responses were measured in a Likert scale format with values 1 = strongly disagree; 2 = disagree; 3 = neither agree nor disagree; 4 = agree; 5 =strongly agree. Questions 2 and 4 were scored reversely. The questionnaire was given in printed form at discharge, and the responses were collected by telephone call the day after the procedure.
Sample size estimation and statistical analyses The primary endpoint of the study was the occurrence of major desaturation events (i.e., SpO2 <80% with nasal oxygen supply 2 L/min). Assuming a desaturation rate of 20 ± 5%, we calculated a lower critical number of 25 patients per group to prove non-inferiority within the above limits of the primary endpoint, with a p-value of <0.05 and 85% power.
- Conditions
- Lung Diseases, Diagnosis, Anesthesia
- Being tested
- Dexmedetomidine, Ketamine, Midazolam, Fentanyl
- Medical subject headings
- Lung Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexmedetomidine administration
Dexmedetomidine solution of 1 μg/kg dissolved in 60 ml saline was administered over 15 minutes, followed by a maintenance dose of 0.5 μg/kg/h (continuous infusion).
KetamineDrug
Also called Ketamine administration
A bolus dose of 50 mg ketamine dissolved in 10 ml saline was given 15 minutes after Dexmedetomidine initiation.
MidazolamDrug
Also called Midazolam administration
Bolus doses of midazolam (5 mg midazolam dissolved in 10 ml saline; 2 ml of the solution or 1 mg midazolam per bolus, premedication dose of 2mg, induction dose of 2 mg) were administered at 20-minute intervals in between and titrated as needed to obtain the desired sedation depth. No more than 12 mg of midazolam were administered.
FentanylDrug
Also called Fentanyl administration
Bolus doses of fentanyl (100 μg / 10 ml; 5 ml of the solution or 50 μg fentanyl per bolus, induction dose of 50μg) were administered at 20-minute intervals in between and titrated as needed to obtain the desired sedation depth. No more than 150 μg of fentanyl were administered.
| Study group | Role | What they receive |
|---|---|---|
| DK group | Experimental | Dexmedetomidine solution of 1 μg/kg dissolved in 60 ml saline was administered over 15 minutes, followed by a maintenance dose of 0.5 μg/kg/h (continuous infusion). After the first 15 minutes, a bolus dose of 50 mg ketamine dissolved in 10 ml saline was given. Receives: Drug: Dexmedetomidine; Drug: Ketamine |
| MF group | Active comparator | Bolus doses of midazolam (5 mg midazolam dissolved in 10 ml saline; 2 ml of the solution or 1 mg midazolam per bolus, premedication dose of 2mg, induction dose of 2 mg) and fentanyl (100 μg / 10 ml; 5 ml of the solution or 50 μg fentanyl per bolus, induction dose of 50μg) were administered at 20-minute intervals in between and titrated as needed to obtain the desired sedation depth. No more than 12 mg of midazolam and 150 μg of fentanyl were administered. Receives: Drug: Midazolam; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of sedation Ramsay
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Measured: Minute 10 of procedure
Depth of sedation Ramsay
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Measured: Minute 20 of procedure
Depth of sedation Ramsay
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Measured: Minute 30 of procedure
Depth of sedation Ramsay
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Measured: Minute 40 of procedure
Depth of sedation Ramsay
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Measured: Minute 50 of procedure
Depth of sedation Ramsay
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Measured: Minute 60 of procedure
Depth of sedation Ramsay
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Measured: Minute 70 of procedure
Depth of sedation Ramsay
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Measured: Minute 80 of procedure
Depth of sedation Ramsay
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Measured: Minute 90 of procedure
Depth of sedation Riker
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Measured: Minute 10 of procedure
Depth of sedation Riker
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Measured: Minute 20 of procedure
Depth of sedation Riker
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Measured: Minute 30 of procedure
Depth of sedation Riker
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Measured: Minute 40 of procedure
Depth of sedation Riker
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Measured: Minute 50 of procedure
Depth of sedation Riker
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Measured: Minute 60 of procedure
Depth of sedation Riker
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Measured: Minute 70 of procedure
Depth of sedation Riker
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Measured: Minute 80 of procedure
Depth of sedation Riker
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Measured: Minute 90 of procedure
Bronchoscopist satisfaction
Bronchoscopist satisfaction was measured with a Likert-scale tool answering the question "How satisfied are you with both the ease and outcome of the procedure?" as follows: 1 = not satisfied at all; 2 = somewhat satisfied; 3 = more satisfied with the procedural outcome; 4 = mostly satisfied with the outcome and somewhat with procedural ease; 5 = exceptionally satisfied with both procedural outcome and ease.
Measured: 1 hour after the end of the procedure
Patient satisfaction
Patient satisfaction was evaluated by a short, custom-made questionnaire that included the following questions: 1) I was satisfied with the sedation administered for the procedure, 2) I felt pain and/or discomfort beyond my tolerance during the procedure, 3) I believe my needs were met during the procedure 4) I felt pain and discomfort after the procedure, 5) I would be willing to undergo a second procedure if the first did not yield adequate results. The responses were measured in a Likert scale format with values 1 = strongly disagree; 2 = disagree; 3 = neither agree nor disagree; 4 = agree; 5 =strongly agree. Questions 2 and 4 were scored reversely.
Measured: 24 hours after bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Sep 2019
- Primary completion31 May 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fouzas Sotirios, University of Patras
- Investigators
- Sotirios Fouzas, MD, PhD, Principal investigator, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185127
- Sponsor's protocol ID
- DKvFM
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine-ketamine Combination Versus Fentanyl-midazolam for Patient Sedation During Flexible Bronchoscopy: a Prospective, Single-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06185127
- Acronym / sponsor ID
- DKvFM
- Conditions
- Lung Diseases, Diagnosis, Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 29 Dec 2023 (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.
Sedation during flexible bronchoscopy (FB) should maintain an adequate respiratory drive, ensure maximum comfort for the patient, and warrant that the objectives of the procedure are achieved. Nevertheless, the optimal sedation method for FB has yet to be established. This study aimed to compare the standard recommended combination of midazolam-fentanyl (MF) with that of dexmedetomidine-ketamine (DK) for patient sedation during FB. Patients subjected to FB were randomly assigned to a DK (n=25) and an MF group (n=25). The primary outcome was the rate of critical desaturation events (arterial oxygen saturation <80% with nasal oxygen supply 2 L/min). Secondary outcomes included sedation depth, hemodynamic complications, adverse events, and patient and bronchoscopist satisfaction.
Detailed description
Study design and population This randomized controlled trial of adult patients (age >18 years) scheduled for FB was conducted between September 2019 and May 2020 at the Respiratory Medicine Department of Athens Naval Hospital, Greece.
Exclusion criteria included: known or suspected allergy to any of the study drugs, renal impairment (serum creatinine > 2 mg/dL), hepatic impairment (liver enzymes > 2 times the upper limit of normal), seizure disorders, history of psychosis or bipolar disorder, hemodynamic instability (heart rate - HR < 50 bpm or systolic blood pressure - SBP < 90 mmHg), and critically ill patients. The study protocol was approved by the Ethics Committee of Athens Naval Hospital (act number 296/13.08.2019), and written informed consent was obtained from all participants.
Protocol Demographic data and medical history were reviewed at the presentation, and the vital signs were assessed and recorded.
Eligible patients were then randomly assigned to two groups:
- DK group: Dexmedetomidine solution of 1 μg/kg dissolved in 60 ml saline was administered over 15 minutes, followed by a maintenance dose of 0.5 μg/kg/h (continuous infusion). After the first 15 minutes, a bolus dose of 50 mg ketamine dissolved in 10 ml saline was given. An increase of 0.1 μg/kg in the infusion rate of dexmedetomidine was considered when necessary to optimize the level of sedation.
- MF group: Bolus doses of midazolam (5 mg midazolam dissolved in 10 ml saline; 2 ml of the solution or 1 mg midazolam per bolus, premedication dose of 2mg, induction dose of 2 mg) and fentanyl (100 μg / 10 ml; 5 ml of the solution or 50 μg fentanyl per bolus, induction dose of 50μg) were administered at 20-minute intervals in between and titrated as needed to obtain the desired sedation depth. No more than 12 mg of midazolam and 150 μg of fentanyl were administered.
The depth of sedation was quantified at the onset of drug infusion using the Observer's Assessment of Alertness/Sedation scale; a maximum score of 3 was considered optimal for starting FB. Bolus doses of dexmedetomidine (DK group) and midazolam (MF group) were administered when necessary to maintain the same target score. An anesthesiologist was present throughout the procedure to oversee and monitor the sedation protocol. Only the anesthesiologist and the nurse of the bronchoscopy suite were aware of the sedation regimen. The attending pulmonologist remained blind regarding the sedation protocol until the completion of the bronchoscopist satisfaction questionnaire (see below).
Lidocaine gel was placed at the nostril of entry before the procedure, and lidocaine (4 ml of 2% solution) was sprayed under direct vision through the bronchoscope for vocal cord anesthesia before entering the larynx. All participants (in both the MF and the DK group) were initially premedicated with 2 mg of midazolam for anxiolysis and perioperative amnesia 10 minutes before commencing the procedure. They also received oxygen at 2 L/min via nasal cannula and 0.9 NaCl i.v. at 8 ml/h throughout the procedure. Continuous monitoring included electrocardiography, oxygen saturation (SpO2), and automated non-invasive blood pressure recordings.
Outcomes The depth of sedation was evaluated using the Ramsay sedation scale [28] and the Riker sedation-agitation scale. Both tools provide quantitative measurements in the maximum and minimum sedation-agitation range during the procedure. Higher Ramsay and lower Riker scores signify deeper sedation levels.
Bronchoscopist satisfaction was measured with a Likert-scale tool answering the question "How satisfied are you with both the ease and outcome of the procedure?" as follows: 1 = not satisfied at all; 2 = somewhat satisfied; 3 = more satisfied with the procedural outcome; 4 = mostly satisfied with the outcome and somewhat with procedural ease; 5 = exceptionally satisfied with both procedural outcome and ease.
Patient satisfaction was evaluated by a short, custom-made questionnaire that included the following questions: 1) I was satisfied with the sedation administered for the procedure, 2) I felt pain and/or discomfort beyond my tolerance during the procedure, 3) I believe my needs were met during the procedure 4) I felt pain and discomfort after the procedure, 5) I would be willing to undergo a second procedure if the first did not yield adequate results. The responses were measured in a Likert scale format with values 1 = strongly disagree; 2 = disagree; 3 = neither agree nor disagree; 4 = agree; 5 =strongly agree. Questions 2 and 4 were scored reversely. The questionnaire was given in printed form at discharge, and the responses were collected by telephone call the day after the procedure.
Sample size estimation and statistical analyses The primary endpoint of the study was the occurrence of major desaturation events (i.e., SpO2 <80% with nasal oxygen supply 2 L/min). Assuming a desaturation rate of 20 ± 5%, we calculated a lower critical number of 25 patients per group to prove non-inferiority within the above limits of the primary endpoint, with a p-value of <0.05 and 85% power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DK group | Experimental | Drug: Dexmedetomidine, Drug: KetamineDexmedetomidine solution of 1 μg/kg dissolved in 60 ml saline was administered over 15 minutes, followed by a maintenance dose of 0.5 μg/kg/h (continuous infusion). After the first 15 minutes, a bolus dose of 50 mg ketamine dissolved in 10 ml saline was given. |
| MF group | Active comparator | Drug: Midazolam, Drug: FentanylBolus doses of midazolam (5 mg midazolam dissolved in 10 ml saline; 2 ml of the solution or 1 mg midazolam per bolus, premedication dose of 2mg, induction dose of 2 mg) and fentanyl (100 μg / 10 ml; 5 ml of the solution or 50 μg fentanyl per bolus, induction dose of 50μg) were administered at 20-minute intervals in between and titrated as needed to obtain the desired sedation depth. No more than 12 mg of midazolam and 150 μg of fentanyl were administered. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for flexible bronchoscopy at the Naval Hospital of Athens
- Written informed consent
Key exclusion criteria (7 listed)
- known or suspected allergy to any of the study drugs
- renal impairment (serum creatinine > 2 mg/dL)
- hepatic impairment (liver enzymes > 2 times the upper limit of normal)
- seizure disorders
- history of psychosis or bipolar disorder
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 |
|---|---|---|
| DexmedetomidineAlso: Dexmedetomidine administrationDexmedetomidine solution of 1 μg/kg dissolved in 60 ml saline was administered over 15 minutes, followed by a maintenance dose of 0.5 μg/kg/h (continuous infusion). | Drug | DK group |
| KetamineAlso: Ketamine administrationA bolus dose of 50 mg ketamine dissolved in 10 ml saline was given 15 minutes after Dexmedetomidine initiation. | Drug | DK group |
| MidazolamAlso: Midazolam administrationBolus doses of midazolam (5 mg midazolam dissolved in 10 ml saline; 2 ml of the solution or 1 mg midazolam per bolus, premedication dose of 2mg, induction dose of 2 mg) were administered at 20-minute intervals in between and titrated as needed to obtain the desired sedation depth. No more than 12 mg of midazolam were administered. | Drug | MF group |
| FentanylAlso: Fentanyl administrationBolus doses of fentanyl (100 μg / 10 ml; 5 ml of the solution or 50 μg fentanyl per bolus, induction dose of 50μg) were administered at 20-minute intervals in between and titrated as needed to obtain the desired sedation depth. No more than 150 μg of fentanyl were administered. | Drug | MF group |
Primary outcome
Depth of sedation Ramsay
Time frame: Minute 10 of procedure
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Depth of sedation Ramsay
Time frame: Minute 20 of procedure
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Depth of sedation Ramsay
Time frame: Minute 30 of procedure
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Depth of sedation Ramsay
Time frame: Minute 40 of procedure
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Depth of sedation Ramsay
Time frame: Minute 50 of procedure
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Depth of sedation Ramsay
Time frame: Minute 60 of procedure
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Depth of sedation Ramsay
Time frame: Minute 70 of procedure
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Depth of sedation Ramsay
Time frame: Minute 80 of procedure
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Depth of sedation Ramsay
Time frame: Minute 90 of procedure
Assessed by Ramsay sedation scale that divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. (https://www.msdmanuals.com/professional/multimedia/table/the-ramsay-sedation-scale; doi:10.1136/bmj.2.5920.656)
Depth of sedation Riker
Time frame: Minute 10 of procedure
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Depth of sedation Riker
Time frame: Minute 20 of procedure
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Depth of sedation Riker
Time frame: Minute 30 of procedure
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Depth of sedation Riker
Time frame: Minute 40 of procedure
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Depth of sedation Riker
Time frame: Minute 50 of procedure
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Depth of sedation Riker
Time frame: Minute 60 of procedure
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Depth of sedation Riker
Time frame: Minute 70 of procedure
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Depth of sedation Riker
Time frame: Minute 80 of procedure
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Depth of sedation Riker
Time frame: Minute 90 of procedure
Assessed by Riker's Sedation-Agitation Scale that ranges from 1 to 7, with scores of <4 indicating deeper sedation, a score of 4 indicating an appearance of calm and cooperativeness, and scores of ≥5 indicating increasing agitation. (https://www.msdmanuals.com/professional/multimedia/table/riker-sedation-agitation-scale; Crit Care Med. 1999;27:1325-1329)
Bronchoscopist satisfaction
Time frame: 1 hour after the end of the procedure
Bronchoscopist satisfaction was measured with a Likert-scale tool answering the question "How satisfied are you with both the ease and outcome of the procedure?" as follows: 1 = not satisfied at all; 2 = somewhat satisfied; 3 = more satisfied with the procedural outcome; 4 = mostly satisfied with the outcome and somewhat with procedural ease; 5 = exceptionally satisfied with both procedural outcome and ease.
Patient satisfaction
Time frame: 24 hours after bronchoscopy
Patient satisfaction was evaluated by a short, custom-made questionnaire that included the following questions: 1) I was satisfied with the sedation administered for the procedure, 2) I felt pain and/or discomfort beyond my tolerance during the procedure, 3) I believe my needs were met during the procedure 4) I felt pain and discomfort after the procedure, 5) I would be willing to undergo a second procedure if the first did not yield adequate results. The responses were measured in a Likert scale format with values 1 = strongly disagree; 2 = disagree; 3 = neither agree nor disagree; 4 = agree; 5 =strongly agree. Questions 2 and 4 were scored reversely.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Sotirios Fouzas, MD, PhD principal investigator
University of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine, Ketamine and Midazolam in people with Lung Diseases and Diagnosis, run by University of Patras at 1 site in Greece.
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 7 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: finished, as of the sponsor's last update on 29 Dec 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 Greece. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depth of sedation Ramsay (time frame: Minute 10 of procedure). The study lists 20 primary outcomes in all. 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 29 Dec 2023.