Elective ThyroidectomyPhase 4NCT01240109
Effect of Remifentanil on Cough During Emergence From General Anesthesia : Trial to Compare Between Sevoflurane Anesthesia and Propofol Anesthesia
A Phase 4 study testing Remifentanil in people with Elective Thyroidectomy, run by Yonsei University at 1 site in South Korea.
Trial summary
The objective of this study was to compare the effect of remifentanil on suppression cough reflex during emergence in patient anesthetized using either propofol or sevoflurane additionally under infusion of the identical concentration of remifentanil. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Elective Thyroidectomy
- What is being tested?
- Remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Feb 2011
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- females
- ASA I-II
- aged between 20 and 70 year
- general anesthesia for elective thyroidectomy
Who cannot join
- signs of an anatomical or functional abnormality in upper airway
- risk factors for perioperative aspiration
- smoking for recent 8 weeks
- URI or sore throat for recent 2 weeks
- potential of pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Remifentanil on Cough During Emergence From General Anesthesia : Randomized Trial to Comparison Between Sevoflurane Anesthesia and Propofol Anesthesia
The objective of this study was to compare the effect of remifentanil on suppression cough reflex during emergence in patient anesthetized using either propofol or sevoflurane additionally under infusion of the identical concentration of remifentanil.
Read the detailed description
During recovery from general anesthesia the stimuli of endotracheal tube lead to the coughing, hypertension, tachycardia, which can cause a serious complication.
It has been demonstrated that opioid, intravenous or topical lidocaine administration can attenuate the coughing reflex.
Administered the opioid before emergence, it is effective to prevent cough reflex but the recovery is delayed, it was difficult to predict emergence.
However, remifentanil is an opioid widely used because of rapid context-sensitive half-life, target-controled infusion method to adequately maintain the effect site concentration could help to predict the recovery time to the alert state from the general anesthesia. It is considered proper method of continuous infusion of remifentanil for reducing emergence cough.
Recent reporters suggest that antitussive effect of remifentanil differs depend on main anesthetic agents, the incidence of coughing when tracheal extubation is reduced after propofol anesthesia compared with sevoflurane anesthesia.
However, these studies raise important questions about failure of maintaining the same effect site concentration of remifentanil in both groups.
The objective of this study was to compare the effect of remifentanil on suppression cough reflex during emergence in patient anesthetized using either propofol or sevoflurane additionally under infusion of the identical concentration of remifentanil.
During recovery from general anesthesia the stimuli of endotracheal tube lead to the coughing, hypertension, tachycardia, which can cause a serious complication.
It has been demonstrated that opioid, intravenous or topical lidocaine administration can attenuate the coughing reflex.
Administered the opioid before emergence, it is effective to prevent cough reflex but the recovery is delayed, it was difficult to predict emergence.
However, remifentanil is an opioid widely used because of rapid context-sensitive half-life, target-controled infusion method to adequately maintain the effect site concentration could help to predict the recovery time to the alert state from the general anesthesia. It is considered proper method of continuous infusion of remifentanil for reducing emergence cough.
Recent reporters suggest that antitussive effect of remifentanil differs depend on main anesthetic agents, the incidence of coughing when tracheal extubation is reduced after propofol anesthesia compared with sevoflurane anesthesia.
However, these studies raise important questions about failure of maintaining the same effect site concentration of remifentanil in both groups.
The objective of this study was to compare the effect of remifentanil on suppression cough reflex during emergence in patient anesthetized using either propofol or sevoflurane additionally under infusion of the identical concentration of remifentanil.
- Conditions
- Elective Thyroidectomy
- Being tested
- Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Ultiva
- propofol group : propofol effect site-TCI 2-4mcg/ml + remifentanil effect site-TCI 2-4ng/ml
- sevoflurane group: sevoflurane end-tidal concentration 0.5-1.0 MAC + remifentanil effect site-TCI 2-4ng/ml
| Study group | Role | What they receive |
|---|---|---|
| propofol | Active comparator | Not described Receives: Drug: Remifentanil |
| sevoflurane | Active comparator | Not described Receives: Drug: Remifentanil |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective ThyroidectomyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Jeong-Rim Lee, MD, Ph.D, Principal investigator, Severance Hospital, Department of Anesthesiology and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240109
- Sponsor's protocol ID
- 4-2010-0369
- Status last verified
- May 2011
- First submitted
- 10 Nov 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
- Effect of Remifentanil on Cough During Emergence From General Anesthesia : Randomized Trial to Comparison Between Sevoflurane Anesthesia and Propofol Anesthesia
- ClinicalTrials.gov ID
- NCT01240109
- Acronym / sponsor ID
- 4-2010-0369
- Conditions
- Elective Thyroidectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 Nov 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.
The objective of this study was to compare the effect of remifentanil on suppression cough reflex during emergence in patient anesthetized using either propofol or sevoflurane additionally under infusion of the identical concentration of remifentanil.
Detailed description
During recovery from general anesthesia the stimuli of endotracheal tube lead to the coughing, hypertension, tachycardia, which can cause a serious complication.
It has been demonstrated that opioid, intravenous or topical lidocaine administration can attenuate the coughing reflex.
Administered the opioid before emergence, it is effective to prevent cough reflex but the recovery is delayed, it was difficult to predict emergence.
However, remifentanil is an opioid widely used because of rapid context-sensitive half-life, target-controled infusion method to adequately maintain the effect site concentration could help to predict the recovery time to the alert state from the general anesthesia. It is considered proper method of continuous infusion of remifentanil for reducing emergence cough.
Recent reporters suggest that antitussive effect of remifentanil differs depend on main anesthetic agents, the incidence of coughing when tracheal extubation is reduced after propofol anesthesia compared with sevoflurane anesthesia.
However, these studies raise important questions about failure of maintaining the same effect site concentration of remifentanil in both groups.
The objective of this study was to compare the effect of remifentanil on suppression cough reflex during emergence in patient anesthetized using either propofol or sevoflurane additionally under infusion of the identical concentration of remifentanil.
During recovery from general anesthesia the stimuli of endotracheal tube lead to the coughing, hypertension, tachycardia, which can cause a serious complication.
It has been demonstrated that opioid, intravenous or topical lidocaine administration can attenuate the coughing reflex.
Administered the opioid before emergence, it is effective to prevent cough reflex but the recovery is delayed, it was difficult to predict emergence.
However, remifentanil is an opioid widely used because of rapid context-sensitive half-life, target-controled infusion method to adequately maintain the effect site concentration could help to predict the recovery time to the alert state from the general anesthesia. It is considered proper method of continuous infusion of remifentanil for reducing emergence cough.
Recent reporters suggest that antitussive effect of remifentanil differs depend on main anesthetic agents, the incidence of coughing when tracheal extubation is reduced after propofol anesthesia compared with sevoflurane anesthesia.
However, these studies raise important questions about failure of maintaining the same effect site concentration of remifentanil in both groups.
The objective of this study was to compare the effect of remifentanil on suppression cough reflex during emergence in patient anesthetized using either propofol or sevoflurane additionally under infusion of the identical concentration of remifentanil.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Active comparator | Drug: Remifentanil |
| sevoflurane | Active comparator | Drug: Remifentanil |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- females
- ASA I-II
- aged between 20 and 70 year
- general anesthesia for elective thyroidectomy
Key exclusion criteria (5 listed)
- signs of an anatomical or functional abnormality in upper airway
- risk factors for perioperative aspiration
- smoking for recent 8 weeks
- URI or sore throat for recent 2 weeks
- potential of pregnancy
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 |
|---|---|---|
| RemifentanilAlso: Ultiva* propofol group : propofol effect site-TCI 2-4mcg/ml + remifentanil effect site-TCI 2-4ng/ml * sevoflurane group: sevoflurane end-tidal concentration 0.5-1.0 MAC + remifentanil effect site-TCI 2-4ng/ml | Drug | propofol, sevoflurane |
Primary outcome
Not reported in the source record.
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.
Related trials for Elective Thyroidectomy
Recruiting
Opioid-Free Versus Opioid-Based Anesthesia in Thyroid Surgery
Thyroidectomy, Oxidative Stress
Not yet recruitingObservational study
Postoperative Analgesia and Recovery Quality in Total Thyroidectomy
Postoperative Pain
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.
Jeong-Rim Lee, MD, Ph.D principal investigator
Severance Hospital, Department of Anesthesiology and Pain Medicine
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 Elective Thyroidectomy, 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 4 inclusion and 5 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.
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.