Conscious Sedation During ProcedurePhase 2/3NCT02713191
Dexmedetomidine vs. Midazolam Sedation for Endobronchial Ultrasound
A Phase 2/3 study testing Dexmedetomidine, Midazolam bolus and Rescue midazolam in people with Conscious Sedation During Procedure and Endobronchial Ultrasound, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
The randomized controlled trial will compare efficacy and safety of dexmedetomidine to midazolam for sedation during endobronchial ultrasound Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Conscious Sedation During Procedure, Endobronchial Ultrasound
- What is being tested?
- Dexmedetomidine, Midazolam bolus and Rescue midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2016to 1 Feb 2017
- Phase
- Phase 2/3
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or more
- American Society of Anesthesiologists physical status I or II
- Presence of hilar and/or mediastinal lymph nodes on thoracic CT scan
Who cannot join
- Known allergy to dexmedetomidine or midazolam or fentanyl
- Documented coagulopathy
- Pregnancy
- Hemodynamic instability (hypotension, arrhythmia, recent acute coronary event)
- Neuropsychiatric illness
- History of previous endobronchial ultrasound procedure
- Refusal to provide consent
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160023
About this study
Official title: Efficacy and Safety of Dexmedetomidine vs. Midazolam Sedation in Patients Undergoing Convex-probe Endobronchial Ultrasound: a Randomized Double Blind Trial
The randomized controlled trial will compare efficacy and safety of dexmedetomidine to midazolam for sedation during endobronchial ultrasound
Read the detailed description
Benzodiazepines, opioids, and propofol are currently used alone or in combination for achieving sedation during endobronchial ultrasound and other bronchoscopic procedures. However, all these agents carry a risk of respiratory depression. Dexmedetomidine, a highly selective adrenergic alpha-2 agonist, has sedative and analgesic properties but does not cause respiratory depression. This study aims to compare efficacy and safety of dexmedetomidine as a sedative to midazolam in patients with hilar/mediastinal lymphadenopathy undergoing convex-probe endobronchial ultrasonography on day care basis. Patients will be randomized to receive either dexmedetomidine plus fentanyl or midazolam plus fentanyl prior to procedure, followed by dexmedetomidine or saline infusion respectively during the procedure. Ramsay sedation score of two will be targeted, failing which patients in both groups will receive midazolam bolus on as-needed basis. Bronchoscopist will remain blinded to group allocation. Patients will be monitored for sedation, oxygenation and hemodynamic parameters throughout. Need for additional midazolam, sedative efficacy, frequency of adverse respiratory and hemodynamic events, and bronchoscopist and patient satisfaction with the procedure will be compared between the two groups.
- Being tested
- Dexmedetomidine, Midazolam bolus, Saline placebo, Rescue midazolam, Fentanyl
- Keywords
- Bronchoscopy, Sedation, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine 1µg/Kg in 100 mL saline intravenously over 10-15 minutes immediately prior to procedure, followed by Dexmedetomidine infusion at 0.6 µg/kg/hour as maintenance dose during entire procedure
Midazolam bolusDrug
Midazolam 2 mg as slow intravenous bolus immediately prior to procedure
Saline placeboOther
100 mL saline infusion over 10-15 minutes immediately prior to procedure
Rescue midazolamDrug
Rescue boluses of 0.5 mg midazolam, if needed during procedure
FentanylDrug
1 µg/kg fentanyl as slow intravenous bolus immediately prior to procedure
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Dexmedetomidine + fentanyl before, and dexmedetomidine infusion during, procedure Receives: Drug: Dexmedetomidine; Drug: Rescue midazolam; Drug: Fentanyl |
| Midazolam | Active comparator | Midazolam + fentanyl before, and matching saline infusion during, procedure Receives: Drug: Midazolam bolus; Other: Saline placebo; Drug: Rescue midazolam; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of midazolam boluses administered to achieve targeted Ramsay sedation score of two
Measured: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
Secondary outcomes (5)
Mean difference in depth of sedation during procedure as assessed by Ramsay scale
Measured: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
Frequency of adverse hemodynamic events - hypotension, hypertension, tachycardia, bradycardia
Measured: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
Frequency of respiratory events - hypoxia, need for air airway maneuvers to maintain oxygenation
Measured: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
Mean difference in patient and physician satisfaction related to procedure as assessed by visual analogue scale
Measured: Immediately after endobronchial ultrasound procedure
Mean difference in time taken to discharge patient from post-procedure recovery room
Measured: From end of endobronchial ultrasound procedure until final patient discharge from recovery room, assessed up to twelve hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conscious Sedation During ProcedureStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashutosh Nath Aggarwal, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713191
- Sponsor's protocol ID
- Renu1
- Status last verified
- Feb 2017
- First submitted
- 20 Jan 2016
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kumari R, Jain K, Agarwal R, Dhooria S, Sehgal IS, Aggarwal AN. Fixed dexmedetomidine infusion versus fixed-dose midazolam bolus as primary sedative for maintaining intra-procedural sedation during endobronchial ultrasound-guided transbronchial needle aspiration: a double blind randomized controlled trial. Expert Rev Respir Med. 2021 Dec;15(12):1597-1604. doi: 10.1080/17476348.2021.1918000. Epub 2021 Apr 25.
PubMed 33849367
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dexmedetomidine vs. Midazolam Sedation in Patients Undergoing Convex-probe Endobronchial Ultrasound: a Randomized Double Blind Trial
- ClinicalTrials.gov ID
- NCT02713191
- Acronym / sponsor ID
- Renu1
- Keywords
- Bronchoscopy, Sedation, Dexmedetomidine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 18 Mar 2016 (estimated)
- 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.
The randomized controlled trial will compare efficacy and safety of dexmedetomidine to midazolam for sedation during endobronchial ultrasound
Detailed description
Benzodiazepines, opioids, and propofol are currently used alone or in combination for achieving sedation during endobronchial ultrasound and other bronchoscopic procedures. However, all these agents carry a risk of respiratory depression. Dexmedetomidine, a highly selective adrenergic alpha-2 agonist, has sedative and analgesic properties but does not cause respiratory depression. This study aims to compare efficacy and safety of dexmedetomidine as a sedative to midazolam in patients with hilar/mediastinal lymphadenopathy undergoing convex-probe endobronchial ultrasonography on day care basis. Patients will be randomized to receive either dexmedetomidine plus fentanyl or midazolam plus fentanyl prior to procedure, followed by dexmedetomidine or saline infusion respectively during the procedure. Ramsay sedation score of two will be targeted, failing which patients in both groups will receive midazolam bolus on as-needed basis. Bronchoscopist will remain blinded to group allocation. Patients will be monitored for sedation, oxygenation and hemodynamic parameters throughout. Need for additional midazolam, sedative efficacy, frequency of adverse respiratory and hemodynamic events, and bronchoscopist and patient satisfaction with the procedure will be compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine, Drug: Rescue midazolam, Drug: FentanylDexmedetomidine + fentanyl before, and dexmedetomidine infusion during, procedure |
| Midazolam | Active comparator | Drug: Midazolam bolus, Other: Saline placebo, Drug: Rescue midazolam, Drug: FentanylMidazolam + fentanyl before, and matching saline infusion during, procedure |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or more
- American Society of Anesthesiologists physical status I or II
- Presence of hilar and/or mediastinal lymph nodes on thoracic CT scan
Key exclusion criteria (7 listed)
- Known allergy to dexmedetomidine or midazolam or fentanyl
- Documented coagulopathy
- Pregnancy
- Hemodynamic instability (hypotension, arrhythmia, recent acute coronary event)
- Neuropsychiatric illness
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine 1µg/Kg in 100 mL saline intravenously over 10-15 minutes immediately prior to procedure, followed by Dexmedetomidine infusion at 0.6 µg/kg/hour as maintenance dose during entire procedure | Drug | Dexmedetomidine |
| Midazolam bolusMidazolam 2 mg as slow intravenous bolus immediately prior to procedure | Drug | Midazolam |
| Saline placebo100 mL saline infusion over 10-15 minutes immediately prior to procedure | Other | Midazolam |
| Rescue midazolamRescue boluses of 0.5 mg midazolam, if needed during procedure | Drug | Dexmedetomidine, Midazolam |
| Fentanyl1 µg/kg fentanyl as slow intravenous bolus immediately prior to procedure | Drug | Dexmedetomidine, Midazolam |
Primary outcome
Number of midazolam boluses administered to achieve targeted Ramsay sedation score of two
Time frame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
5 secondary outcomes
Mean difference in depth of sedation during procedure as assessed by Ramsay scale
Time frame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
Frequency of adverse hemodynamic events - hypotension, hypertension, tachycardia, bradycardia
Time frame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
Frequency of respiratory events - hypoxia, need for air airway maneuvers to maintain oxygenation
Time frame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours
Mean difference in patient and physician satisfaction related to procedure as assessed by visual analogue scale
Time frame: Immediately after endobronchial ultrasound procedure
Mean difference in time taken to discharge patient from post-procedure recovery room
Time frame: From end of endobronchial ultrasound procedure until final patient discharge from recovery room, assessed up to twelve hours
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 17 Feb 2017.
- Derived from this study: PubMed 33849367Kumari R, Jain K, Agarwal R, Dhooria S, Sehgal IS, Aggarwal AN. Fixed dexmedetomidine infusion versus fixed-dose midazolam bolus as primary sedative for maintaining intra-procedural sedation during endobronchial ultrasound-guided transbronchial needle aspiration: a double blind randomized controlled trial. Expert Rev Respir Med. 2021 Dec;15(12):1597-1604. doi: 10.1080/17476348.2021.1918000. Epub 2021 Apr 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine, Midazolam bolus and Rescue midazolam in people with Conscious Sedation During Procedure and Endobronchial Ultrasound, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 3 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 17 Feb 2017. 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 India. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of midazolam boluses administered to achieve targeted Ramsay sedation score of two (time frame: From start of endobronchial ultrasound procedure until finish of endobronchial ultrasound procedure, assessed up to two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02713191, which also lists 1 linked publication.
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 17 Feb 2017.