Intubation, EndotrachealPhase 4NCT00349245
Dexmedetomidine vs. Remifentanil for Sedation During AFI
A Phase 4 study testing Remifentanil and Dexmedetomidine in people with Intubation, Endotracheal, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The objective of this study is to determine the efficacy and safety of Dexmedetomidine, a selective alpha-2 adrenoceptor agonist, which has recently gained increased popularity for ICU and intraoperative sedation as a sedative during awake fiberoptic intubation, as compared to Remifentanil. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation, Endotracheal
- What is being tested?
- Remifentanil and Dexmedetomidine
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Aug 2007
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A signed informed consent must be obtained after the nature of the study has been fully explained.
- Patients undergoing any procedure requiring general anesthesia with an endotracheal tube.
- Patients that have been assessed by an attending anesthesiologist to have an airway requiring awake fiberoptic intubation.
- Adult patients > 18 yrs. old, ASA I - III.
Who cannot join
- Patients expected to have severe adverse side effects to Dexmedetomidine including:
- Previous allergy to the drug.
- 3rd degree AV Block
- Hypovolemic hypotension
- Systemic vasoconstriction
- Patients expected to have a severe adverse side effect to Remifentanil. This includes:
Show all 9Show fewer
- Previous allergy to the drug.
- Patients suspected of being overly sensitive to narcotics.
- Patients with significant cardiovascular disease or ASA physical status IV and V
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind Comparison Of Dexmedetomidine And Remifentanil For Sedation During Awake Fiberoptic Intubations
The objective of this study is to determine the efficacy and safety of Dexmedetomidine, a selective alpha-2 adrenoceptor agonist, which has recently gained increased popularity for ICU and intraoperative sedation as a sedative during awake fiberoptic intubation, as compared to Remifentanil.
The hypothesis is that Dexmedetomidine will provide at least equal if not better conditions (sedation and analgesia) required for awake fiberoptic intubation (Ramsay Sedation Scale 3) with less respiratory and cardiovascular adverse effects, as well as less recall than Remifentanil.
Read the detailed description
Awake nasal or oral fiberoptic intubation remains the method of choice for airway management in the expected difficult airway. This technique requires that a patient be comfortable, relaxed, cooperative and able to maintain their airway with spontaneous ventilation.
In order to achieve these conditions, the pharmacologic agent chosen for sedation should be short acting and highly titratable, provide the required amount of sedation and have little suppression of spontaneous ventilation. There have been numerous reports of the use of Remifentanil and Propofol used either alone or in combination to achieve this level of sedation.
Remifentanil has the following advantages which makes it a useful drug for this purpose:
- Ultra short acting with a constant half life
- Anti-tussive effects which help prevent coughing with tracheal manipulation
- Reversible with an antagonist naloxone
- Attenuates cardiovascular responses to laryngoscopy
Shortcomings of Remifentanil include undesirable side effects, such as hemodynamic instability and respiratory depression.
Dexmedetomidine is a centrally acting, selective alpha-2 agonist which has gained increasing popularity since 1999 as a drug for sedation in ICU settings. It has also been used for intraoperative sedation during surgery under regional anesthesia and for awake craniotomies, as well as for sedation of pediatric patients in different settings. Finally, there are also case reports of Dexmedetomidine being used for awake fiberoptic tracheal intubation.
Theoretically, the pharmacokinetic and pharmacodynamic properties of Dexmedetomidine make it an ideal drug as a single agent for sedation for awake fiberoptic intubation. Venn et al showed that in both healthy individuals and ICU patients, Dexmedetomidine shows a rapid onset and equally rapid distribution half life with quick recovery. This study also demonstrated stable hemodynamics during airway manipulation (extubation) with no adverse cardiovascular or respiratory events during the study.
Other studies have demonstrated that Dexmedetomidine attenuates cardiovascular responses to laryngoscopy and intubation and reduces the need for perioperative opioids. In small doses, it has been demonstrated to have good sedative, amnestic and analgesic effects, as well as anti-sialogogue effects.
Dexmedetomidine does, however, have some drawbacks. In higher bolus doses it can cause hemodynamic changes, such as excessive bradycardia and hypertension followed by hypotension. This drug has also been associated with decreased regional and global cerebral blood flow despite maintenance of MAP within the auto-regulating parameters. These deleterious effects are more prominent in patients with hypovolemia, systemic vasoconstriction, AV block and with rapid bolus infusion.
- Conditions
- Intubation, Endotracheal
- Being tested
- Remifentanil, Dexmedetomidine
- Keywords
- Endotracheal, Awake fiberoptic intubation, Dexmedetomidine, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
DexmedetomidineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's reaction to procedure, as it occurs, ie. grimace, gag, verbalized pain.
Measured: duration of intubation
Memory recall
Measured: post operative, immediately every 30 min for 3 hours and 24 hours
Secondary outcomes (9)
NIBP
Measured: duration of intubation and first 15 minutes of surgery
HR
Measured: duration of intubation and first 15 minutes of surgery
Cardiac rhythm
Measured: duration of surgery
Oxygen saturation
Measured: duration of intubation and first 15 minutes of surgery
End-tidal carbon dioxide
Measured: duration of intubation and first 15 minutes of surgery
Continuous ECG
Measured: duration of intubation and first 15 minutes of surgery
Pulse oximetry
Measured: duration of intubation and first 15 minutes of surgery
Bispectral index
Measured: duration of intubation
Respiratory rate
Measured: duration of intubation and first 15 minutes of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, EndotrachealStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Responsible party
- Principal investigator, Carin A. Hagberg, The University of Texas Health Science Center, Houston
- Investigators
- Carin A Hagberg, M.D., Principal investigator, The University of Texas Medical School at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349245
- Sponsor's protocol ID
- HSC-MS-06-0173
- Status last verified
- Mar 2016
- First submitted
- 5 Jul 2006
- Last updated
- 23 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Comparison Of Dexmedetomidine And Remifentanil For Sedation During Awake Fiberoptic Intubations
- ClinicalTrials.gov ID
- NCT00349245
- Acronym / sponsor ID
- HSC-MS-06-0173
- Conditions
- Intubation, Endotracheal
- Keywords
- Endotracheal, Awake fiberoptic intubation, Dexmedetomidine, Remifentanil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Study start
- Jun 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 6 Jul 2006 (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 objective of this study is to determine the efficacy and safety of Dexmedetomidine, a selective alpha-2 adrenoceptor agonist, which has recently gained increased popularity for ICU and intraoperative sedation as a sedative during awake fiberoptic intubation, as compared to Remifentanil.
The hypothesis is that Dexmedetomidine will provide at least equal if not better conditions (sedation and analgesia) required for awake fiberoptic intubation (Ramsay Sedation Scale 3) with less respiratory and cardiovascular adverse effects, as well as less recall than Remifentanil.
Detailed description
Awake nasal or oral fiberoptic intubation remains the method of choice for airway management in the expected difficult airway. This technique requires that a patient be comfortable, relaxed, cooperative and able to maintain their airway with spontaneous ventilation.
In order to achieve these conditions, the pharmacologic agent chosen for sedation should be short acting and highly titratable, provide the required amount of sedation and have little suppression of spontaneous ventilation. There have been numerous reports of the use of Remifentanil and Propofol used either alone or in combination to achieve this level of sedation.
Remifentanil has the following advantages which makes it a useful drug for this purpose:
- Ultra short acting with a constant half life
- Anti-tussive effects which help prevent coughing with tracheal manipulation
- Reversible with an antagonist naloxone
- Attenuates cardiovascular responses to laryngoscopy
Shortcomings of Remifentanil include undesirable side effects, such as hemodynamic instability and respiratory depression.
Dexmedetomidine is a centrally acting, selective alpha-2 agonist which has gained increasing popularity since 1999 as a drug for sedation in ICU settings. It has also been used for intraoperative sedation during surgery under regional anesthesia and for awake craniotomies, as well as for sedation of pediatric patients in different settings. Finally, there are also case reports of Dexmedetomidine being used for awake fiberoptic tracheal intubation.
Theoretically, the pharmacokinetic and pharmacodynamic properties of Dexmedetomidine make it an ideal drug as a single agent for sedation for awake fiberoptic intubation. Venn et al showed that in both healthy individuals and ICU patients, Dexmedetomidine shows a rapid onset and equally rapid distribution half life with quick recovery. This study also demonstrated stable hemodynamics during airway manipulation (extubation) with no adverse cardiovascular or respiratory events during the study.
Other studies have demonstrated that Dexmedetomidine attenuates cardiovascular responses to laryngoscopy and intubation and reduces the need for perioperative opioids. In small doses, it has been demonstrated to have good sedative, amnestic and analgesic effects, as well as anti-sialogogue effects.
Dexmedetomidine does, however, have some drawbacks. In higher bolus doses it can cause hemodynamic changes, such as excessive bradycardia and hypertension followed by hypotension. This drug has also been associated with decreased regional and global cerebral blood flow despite maintenance of MAP within the auto-regulating parameters. These deleterious effects are more prominent in patients with hypovolemia, systemic vasoconstriction, AV block and with rapid bolus infusion.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A signed informed consent must be obtained after the nature of the study has been fully explained.
- Patients undergoing any procedure requiring general anesthesia with an endotracheal tube.
- Patients that have been assessed by an attending anesthesiologist to have an airway requiring awake fiberoptic intubation.
- Adult patients > 18 yrs. old, ASA I - III.
Key exclusion criteria (9 listed)
- Patients expected to have severe adverse side effects to Dexmedetomidine including:
- Patients expected to have a severe adverse side effect to Remifentanil. This includes:
- Patients with significant cardiovascular disease or ASA physical status IV and V
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 |
|---|---|---|
| Remifentanil | Drug | – |
| Dexmedetomidine | Drug | – |
Primary outcome
Patient's reaction to procedure, as it occurs, ie. grimace, gag, verbalized pain.
Time frame: duration of intubation
Memory recall
Time frame: post operative, immediately every 30 min for 3 hours and 24 hours
9 secondary outcomes
NIBP
Time frame: duration of intubation and first 15 minutes of surgery
HR
Time frame: duration of intubation and first 15 minutes of surgery
Cardiac rhythm
Time frame: duration of surgery
Oxygen saturation
Time frame: duration of intubation and first 15 minutes of surgery
End-tidal carbon dioxide
Time frame: duration of intubation and first 15 minutes of surgery
Continuous ECG
Time frame: duration of intubation and first 15 minutes of surgery
Pulse oximetry
Time frame: duration of intubation and first 15 minutes of surgery
Bispectral index
Time frame: duration of intubation
Respiratory rate
Time frame: duration of intubation and first 15 minutes of surgery
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 23 Mar 2016.
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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.
Carin A Hagberg, M.D. principal investigator
The University of Texas Medical School at Houston
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 and Dexmedetomidine in people with Intubation, Endotracheal, run by The University of Texas Health Science Center, Houston 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 4 inclusion and 9 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 23 Mar 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 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 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?
Patient's reaction to procedure, as it occurs, ie. grimace, gag, verbalized pain. (time frame: duration of intubation). The study lists 2 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 23 Mar 2016.