IntubationPhase 4NCT02844894
Hemodynamic Response to Intubation
A Phase 4 study testing Dexmedetomidine and Esmolol in people with Intubation, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effects of dexmedetomidine and esmolol given intravenously before intubation on sympathetic response caused by intubation itself. Half the patients will recevice dexmedetomidine and the other half will receive dexmedetomidine. Ischemia modified albumine levels will be measured Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intubation
- What is being tested?
- Dexmedetomidine and Esmolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2016to Sep 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective surgery under general anesthesia
Who cannot join
- Patient refusal
- Morbid obesity (BMI>30)
- Advanced systemic disease
- Hypoalbumiemia
- beta-blocker usage
- Anticipated difficult ventilation and/or intubation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ufuk University Hospital
Ankara, 06520
Ulku C Koksoy, Fellow, +903122044000 ext. 4099, cerenkoksoy@gmail.com
About this study
Official title: The Effects of Preintubation Esmolol and and Dexmedotimidine on Ischmeia Modified Albumin Levels
This study investigates the effects of dexmedetomidine and esmolol given intravenously before intubation on sympathetic response caused by intubation itself. Half the patients will recevice dexmedetomidine and the other half will receive dexmedetomidine. Ischemia modified albumine levels will be measured
- Conditions
- Intubation
- Being tested
- Dexmedetomidine, Esmolol, Placebo
- Keywords
- intubation, ischemia modified albumine, dexmedetomidine, esmolol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
EsmololDrug
PlaceboDrug
normal saline
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | 0.5 mcg/kg dexmedetomidine in 20 ml normal saline will be infused in 5 minutes before intubation Receives: Drug: Dexmedetomidine |
| Esmolol | Experimental | 0.5 mg/kg esmolol in 20 ml normal saline will be infused in 5 minutes before intubation Receives: Drug: Esmolol |
| Placebo | Placebo comparator | 20 ml normal saline infused in 5 minutes before intubation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemia modified albumine
ischemia modified albumine levels will be measured as a response to intubation
Measured: 10 minutes after endotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2016 (estimated)
- Study completionSep 2016 (estimated)
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 IntubationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Perihan Ekmekçi, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844894
- Sponsor's protocol ID
- RespToIntubation
- Status last verified
- Jul 2016
- First submitted
- 22 Jul 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yallapragada SV, Vidadala KS, Vemuri NN, Shaik MS. Comparison of the efficacy of dexmedetomidine with that of esmolol in attenuating laryngoscopic and intubation response after rapid sequence induction. Anesth Essays Res. 2014 Sep-Dec;8(3):383-7. doi: 10.4103/0259-1162.143154.
PubMed 25886340
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Preintubation Esmolol and and Dexmedotimidine on Ischmeia Modified Albumin Levels
- ClinicalTrials.gov ID
- NCT02844894
- Acronym / sponsor ID
- RespToIntubation
- Conditions
- Intubation
- Keywords
- intubation, ischemia modified albumine, dexmedetomidine, esmolol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 26 Jul 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.
This study investigates the effects of dexmedetomidine and esmolol given intravenously before intubation on sympathetic response caused by intubation itself. Half the patients will recevice dexmedetomidine and the other half will receive dexmedetomidine. Ischemia modified albumine levels will be measured
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Experimental | Drug: Dexmedetomidine0.5 mcg/kg dexmedetomidine in 20 ml normal saline will be infused in 5 minutes before intubation |
| Esmolol | Experimental | Drug: Esmolol0.5 mg/kg esmolol in 20 ml normal saline will be infused in 5 minutes before intubation |
| Placebo | Placebo comparator | Drug: Placebo20 ml normal saline infused in 5 minutes before intubation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective surgery under general anesthesia
Key exclusion criteria (6 listed)
- Patient refusal
- Morbid obesity (BMI>30)
- Advanced systemic disease
- Hypoalbumiemia
- beta-blocker usage
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 |
|---|---|---|
| Dexmedetomidine | Drug | dexmedetomidine |
| Esmolol | Drug | Esmolol |
| Placebonormal saline | Drug | Placebo |
Primary outcome
ischemia modified albumine
Time frame: 10 minutes after endotracheal intubation
ischemia modified albumine levels will be measured as a response to intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Results publication: PubMed 25886340Yallapragada SV, Vidadala KS, Vemuri NN, Shaik MS. Comparison of the efficacy of dexmedetomidine with that of esmolol in attenuating laryngoscopic and intubation response after rapid sequence induction. Anesth Essays Res. 2014 Sep-Dec;8(3):383-7. doi: 10.4103/0259-1162.143154.
- Individual participant dataSharing planned: No
Related trials for Intubation
Not yet recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Recruiting
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Intubation Complication
Not yet recruiting
OR Video-Laryngoscope Evaluations
Video Laryngoscopy, Quality Improvement
Not yet recruitingObservational study
Patient State Index at Laryngoscopy and Tracheal Intubation Conditions
Anesthesia, Intubation, Endotracheal
Enrolling by invitation
A Study Of T1/Tref Intubating Conditions
Intubation
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.
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 Dexmedetomidine and Esmolol in people with Intubation, run by Ufuk University at 1 site in Turkey (Türkiye).
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Jul 2016. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Perihan Ekmekçi, Ass Prof (+903122044000 ext. 4099, erdogduperi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ischemia modified albumine (time frame: 10 minutes after endotracheal intubation). 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 NCT02844894, 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 26 Jul 2016.