Intubation ComplicationPhase 2NCT01289769
The Effect of Dexmedetomidine on Hemodynamic Response During Double Lumen Endotracheal Intubation
A Phase 2 study testing Dexmedetomidine in people with Intubation Complication and Tracheal Intubation Morbidity, run by Chiang Mai University at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate the effect of dexmedetomidine on hemodynamic responses during laryngoscopy and double lumen endotracheal intubation and assess the adverse effect related to complications of dexmedetomidine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intubation Complication, Tracheal Intubation Morbidity, Anesthesia Intubation Complication
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2011to Dec 2011
- Phase
- Phase 2
- 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
- ASA Physical Status I-III
- Undergoing Elective Thoracotomy or Thoracoscopy
- Required Left Sided-double Lumen Endotracheal Intubation
Who cannot join
- Patients with bradycardia (heart rate < 50 beat per minute) or heart block
- Suspected of Difficult Intubation
- Patients Who Are at Risk for Rapid Change of Hemodynamics
- Allergic to Dexmedetomidine
- Hepatic or Renal Impairment (Preoperative Serum Creatinine > 1.5 mg/dl)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Prophylactic Dexmedetomidine on Hemodynamic Disturbances During Double Lumen Endotracheal Intubation. A Double-blinded, Randomized, Placebo-Controlled Trial.
The purpose of this study is to evaluate the effect of dexmedetomidine on hemodynamic responses during laryngoscopy and double lumen endotracheal intubation and assess the adverse effect related to complications of dexmedetomidine.
Read the detailed description
The cardiovascular responses to laryngoscopy and tracheal intubation are mediated by both sympathetic and parasympathetic nervous system. The hemodynamic responses resulting from sympathetic nervous system stimulation are tachycardia, cardiac arrhythmias, hypertension, increased intraocular pressure, increased intracranial pressure, bronchospasm and myocardial ischemia. Tachycardia is one of the major predictor of intraoperative myocardial ischemia and causes an imbalance of myocardial oxygen supply and demand. Although hemodynamic responses to laryngoscopy and intubation is transient, these effect may be harmful to patients suffering from myocardial and cerebrovascular diseases. The placement of double lumen endotracheal tube may produce similar or greater pressor response than endotracheal tube because of larger sizes and greater carinal stimulation.
- Conditions
- Intubation Complication, Tracheal Intubation Morbidity, Anesthesia Intubation Complication, Hypertension, High Blood Pressure, Tachycardia
- Being tested
- Dexmedetomidine, Placebo
- Medical subject headings
- Hypertension, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
dexmedetomidine 0.7 microgram per kilogram in saline 20 ml given within 10 minutes before intubation
PlaceboDrug
normal saline 20 ml( the same volume as dexmedetomidine) giving within 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Active comparator | Not described Receives: Drug: Dexmedetomidine |
| control | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in systolic blood pressure
direct arterial pressure monitoring
Measured: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
change in diastolic blood pressure
direct arterial pressure monitoring
Measured: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
change in mean arterial pressure
direct arterial pressure monitoring
Measured: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
change in heart rate
Measured: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
Secondary outcomes (1)
adverse events related to dexmedetomidine
bradycardia, hypotension, arrhythmia
Measured: (day 1) during dexmedetomidine administration until 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 posted4 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanyong Pipanmekaporn, Chiang Mai University
- Investigators
- Tanyong Pipanmekaporn, MD, Principal investigator, Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289769
- Sponsor's protocol ID
- COM-10-11-19B-11
- Other IDs
- research ID 77
- Status last verified
- Dec 2011
- First submitted
- 1 Feb 2011
- Last updated
- 15 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Basar H, Akpinar S, Doganci N, Buyukkocak U, Kaymak C, Sert O, Apan A. The effects of preanesthetic, single-dose dexmedetomidine on induction, hemodynamic, and cardiovascular parameters. J Clin Anesth. 2008 Sep;20(6):431-6. doi: 10.1016/j.jclinane.2008.04.007.
PubMed 18929283Maguire A, Thompson JP, Guest C, Sadler PJ, Strupish JW, West KJ. Comparison of the effects of intravenous alfentanil and esmolol on the cardiovascular response to double-lumen endobronchial intubation. Anaesthesia. 2001 Apr;56(4):319-25. doi: 10.1046/j.1365-2044.2001.01917.x.
PubMed 11284817Pipanmekaporn T, Punjasawadwong Y, Charuluxananan S, Lapisatepun W, Bunburaphong P. The effect of prophylactic dexmedetomidine on hemodynamic disturbances to double-lumen endotracheal intubation: a prospective, randomized, double-blind, and placebo-controlled trial. Anesthesiol Res Pract. 2013;2013:236089. doi: 10.1155/2013/236089. Epub 2013 Jul 29.
PubMed 23983684
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prophylactic Dexmedetomidine on Hemodynamic Disturbances During Double Lumen Endotracheal Intubation. A Double-blinded, Randomized, Placebo-Controlled Trial.
- ClinicalTrials.gov ID
- NCT01289769
- Acronym / sponsor ID
- COM-10-11-19B-11
- Conditions
- Intubation Complication, Tracheal Intubation Morbidity, Anesthesia Intubation Complication, Hypertension, High Blood Pressure, Tachycardia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Feb 2011 (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 purpose of this study is to evaluate the effect of dexmedetomidine on hemodynamic responses during laryngoscopy and double lumen endotracheal intubation and assess the adverse effect related to complications of dexmedetomidine.
Detailed description
The cardiovascular responses to laryngoscopy and tracheal intubation are mediated by both sympathetic and parasympathetic nervous system. The hemodynamic responses resulting from sympathetic nervous system stimulation are tachycardia, cardiac arrhythmias, hypertension, increased intraocular pressure, increased intracranial pressure, bronchospasm and myocardial ischemia. Tachycardia is one of the major predictor of intraoperative myocardial ischemia and causes an imbalance of myocardial oxygen supply and demand. Although hemodynamic responses to laryngoscopy and intubation is transient, these effect may be harmful to patients suffering from myocardial and cerebrovascular diseases. The placement of double lumen endotracheal tube may produce similar or greater pressor response than endotracheal tube because of larger sizes and greater carinal stimulation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Active comparator | Drug: Dexmedetomidine |
| control | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA Physical Status I-III
- Undergoing Elective Thoracotomy or Thoracoscopy
- Required Left Sided-double Lumen Endotracheal Intubation
Key exclusion criteria (6 listed)
- Patients with bradycardia (heart rate < 50 beat per minute) or heart block
- Suspected of Difficult Intubation
- Patients Who Are at Risk for Rapid Change of Hemodynamics
- Allergic to Dexmedetomidine
- Hepatic or Renal Impairment (Preoperative Serum Creatinine > 1.5 mg/dl)
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: Precedexdexmedetomidine 0.7 microgram per kilogram in saline 20 ml given within 10 minutes before intubation | Drug | dexmedetomidine |
| Placebonormal saline 20 ml( the same volume as dexmedetomidine) giving within 10 minutes. | Drug | control |
Primary outcome
change in systolic blood pressure
Time frame: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
direct arterial pressure monitoring
change in diastolic blood pressure
Time frame: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
direct arterial pressure monitoring
change in mean arterial pressure
Time frame: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
direct arterial pressure monitoring
change in heart rate
Time frame: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation
1 secondary outcome
adverse events related to dexmedetomidine
Time frame: (day 1) during dexmedetomidine administration until 10 minutes after endotracheal intubation
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 15 Dec 2011.
- Background: PubMed 18929283Basar H, Akpinar S, Doganci N, Buyukkocak U, Kaymak C, Sert O, Apan A. The effects of preanesthetic, single-dose dexmedetomidine on induction, hemodynamic, and cardiovascular parameters. J Clin Anesth. 2008 Sep;20(6):431-6. doi: 10.1016/j.jclinane.2008.04.007.
- Background: PubMed 11284817Maguire A, Thompson JP, Guest C, Sadler PJ, Strupish JW, West KJ. Comparison of the effects of intravenous alfentanil and esmolol on the cardiovascular response to double-lumen endobronchial intubation. Anaesthesia. 2001 Apr;56(4):319-25. doi: 10.1046/j.1365-2044.2001.01917.x.
- Derived from this study: PubMed 23983684Pipanmekaporn T, Punjasawadwong Y, Charuluxananan S, Lapisatepun W, Bunburaphong P. The effect of prophylactic dexmedetomidine on hemodynamic disturbances to double-lumen endotracheal intubation: a prospective, randomized, double-blind, and placebo-controlled trial. Anesthesiol Res Pract. 2013;2013:236089. doi: 10.1155/2013/236089. Epub 2013 Jul 29.
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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.
Tanyong Pipanmekaporn, MD principal investigator
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmedetomidine in people with Intubation Complication and Tracheal Intubation Morbidity, run by Chiang Mai University at 1 site in Thailand.
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 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: finished, as of the sponsor's last update on 15 Dec 2011. 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 Thailand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
change in systolic blood pressure (time frame: (day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation). The study lists 4 primary outcomes in all. 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 NCT01289769, which also lists 3 linked publications.
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 15 Dec 2011.