Cervical Disc HerniationPhase 4NCT01052324
The Effect Site Concentration of Remifentanil for Conscious Sedation During Awake Nasotracheal Fiberoptic Intubation
A Phase 4 study testing Remifentanil in people with Cervical Disc Herniation and Cervical Spinal Stenosis, run by Yonsei University at 1 site in South Korea.
Trial summary
Remifentanil provides analgesia, suppresses airway reflex, has little effect on cognitive function. It can be used for conscious sedation during awake nasotracheal fiberoptic intubation. Target-controlled infusion is more reliable technique for maintaining optimal infusion rate than manual controlled infusion. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Cervical Disc Herniation, Cervical Spinal Stenosis, Cervical Spine Damage
- What is being tested?
- Remifentanil
- Type of treatment
- Injection or infusion
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Nov 2010
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing cervical spine surgery
- Age 20-65
- American Society of Anesthesiologists physical status classification I or II
Who cannot join
- Patients' refusal
- allergy to any drug used
- unable to cooperate
- Severe hepatic or renal disease
- coagulation disorder
- chronic use of opioids or sedatives
- increase risk of pulmonary aspiration.
Trial locations and contacts
1 site in 1 country.
About this study
Remifentanil provides analgesia, suppresses airway reflex, has little effect on cognitive function. It can be used for conscious sedation during awake nasotracheal fiberoptic intubation. Target-controlled infusion is more reliable technique for maintaining optimal infusion rate than manual controlled infusion. The aim of this study is to determine the effect site concentration of remifentanil for successful conscious sedation during awake nasotracheal fiberoptic intubation.
- Being tested
- Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
After topical airway anesthesia with 10 % lidocaine in nostril and oropharyx, 1.5~2.0 mg of IV midazolam is injected. Awake nasotracheal fiberoptic intubation is performed with target-controlled infusion of remifentanil. Initial effect site concentration is 3.0 ng/ml. Smooth intubation is defined as absence of persistent cough with head elevation and defensive movement of extremities. In case of smooth intubation, effect site concentration is decreased by 0.5 ng/ml for the subsequent case. If intubation is not smooth, effect site concentration is increased by 0.5 ng/ml for the subsequent case. EC50 of remifentanil is determined using Dixon's up-and-down method.
What is being measured
The primary outcome is the main question the study is designed to answer.
EC50 of remifentanil for preventing persistent cough and defensive movement using Dixon's up-and-down method
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc HerniationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Primary purpose
- Prevention
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Yuen Hee Shim, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052324
- Sponsor's protocol ID
- 4-2009-0609
- Status last verified
- May 2011
- First submitted
- 11 Jan 2010
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Site Concentration of Remifentanil for Conscious Sedation During Awake Nasotracheal Fiberoptic Intubation
- ClinicalTrials.gov ID
- NCT01052324
- Acronym / sponsor ID
- 4-2009-0609
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 20 Jan 2010 (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.
Remifentanil provides analgesia, suppresses airway reflex, has little effect on cognitive function. It can be used for conscious sedation during awake nasotracheal fiberoptic intubation. Target-controlled infusion is more reliable technique for maintaining optimal infusion rate than manual controlled infusion. The aim of this study is to determine the effect site concentration of remifentanil for successful conscious sedation during awake nasotracheal fiberoptic intubation.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing cervical spine surgery
- Age 20-65
- American Society of Anesthesiologists physical status classification I or II
Key exclusion criteria (7 listed)
- Patients' refusal
- allergy to any drug used
- unable to cooperate
- Severe hepatic or renal disease
- coagulation 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 |
|---|---|---|
| RemifentanilAfter topical airway anesthesia with 10 % lidocaine in nostril and oropharyx, 1.5~2.0 mg of IV midazolam is injected. Awake nasotracheal fiberoptic intubation is performed with target-controlled infusion of remifentanil. Initial effect site concentration is 3.0 ng/ml. Smooth intubation is defined as absence of persistent cough with head elevation and defensive movement of extremities. In case of smooth intubation, effect site concentration is decreased by 0.5 ng/ml for the subsequent case. If intubation is not smooth, effect site concentration is increased by 0.5 ng/ml for the subsequent case. EC50 of remifentanil is determined using Dixon's up-and-down method. | Drug | – |
Primary outcome
EC50 of remifentanil for preventing persistent cough and defensive movement using Dixon's up-and-down method
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 13 May 2011.
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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.
Yuen Hee Shim, MD, PhD principal investigator
Severance Hospital
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 in people with Cervical Disc Herniation and Cervical Spinal Stenosis, run by Yonsei University at 1 site in South Korea.
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 13 May 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 South Korea. 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?
EC50 of remifentanil for preventing persistent cough and defensive movement using Dixon's up-and-down method. 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 13 May 2011.