Thyroid NeoplasmNCT01617694
Comparison Between Remifentanil Target-controlled Infusion and Dexmedetomidine Bolus Administration for Smooth Emergence From General Sevoflurane Anesthesia
A study testing dexmedetomidine and Normal Saline in people with Thyroid Neoplasm, run by Yonsei University at 1 site in South Korea.
Trial summary
Remifentanil target-controlled infusion and dexmedetomidine single-dose administration are known to reduce airway response and haemodynamic stimulation during anaesthetic recovery. The investigators will compare the effects of two drugs on prevention of cough during emergence from general sevoflurane anaesthesia. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Thyroid Neoplasm
- What is being tested?
- dexmedetomidine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Nov 2011
- Phase
- Interventional
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female patient,
- aged 20-60 yr,
- ASA physical status 1-2,
- patients undergoing elective thyroidectomy under general anesthesia
Who cannot join
- sighs of difficult airway,
- history of respiratory disease or chronic cough,
- cardiovascular disease,
- pregnant or breast-feeding woman.
Trial locations and contacts
1 site in 1 country.
About this study
Remifentanil target-controlled infusion and dexmedetomidine single-dose administration are known to reduce airway response and haemodynamic stimulation during anaesthetic recovery. The investigators will compare the effects of two drugs on prevention of cough during emergence from general sevoflurane anaesthesia.
- Conditions
- Thyroid Neoplasm
- Being tested
- dexmedetomidine, Normal Saline
- Keywords
- dexmedetomidine, remifentanil, target-controlled infusion
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
Fifteen minutes before the end of surgery, the first practitioner replace the syringe of remifentanil as new one; new syringe contains remifentanil in remifentanil group (Group R), and normal saline in dexmedetomidine group (Group D), respectively. There are no drug labeling in the new syringe, so the second practitioner can't know which drug was contained in the new syringe. Simultaneously, the second practitioner remifentanil concentration on monitor of TCI pump will be adjusted to 2.0 ng•ml-1. Ten minutes before the end of surgery, 10 ml of dexmedetomidine 0.5 mcg•kg-1 mixed with normal saline will be given for 5 min in Group D; in Group R, 10 ml of normal saline will be given by the first practitioner.
Normal SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| group R | Experimental | continuation of remifentanil target controlled infusion (TCI) at effect-site concentration of 2 ng/ml during anesthetic recovery until extubation. Receives: Drug: dexmedetomidine; Drug: Normal Saline |
| group D | Active comparator | remifentanil TCI discontinuation and dexmedetomidine 0.5 mg/kg intravenous injection before 10 min of the end of surgery Receives: Drug: dexmedetomidine; Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
coughing response
Emergence cough was defined as the cough occurrence during peri-extubation period, from sevoflurane discontinuation to 5 min after extubation. The severity of cough was assessed and recorded by the following cough grading system: Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).
Measured: from discontinuation of anesthetic agent (sevoflurane) to 5 min after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJun 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thyroid NeoplasmStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617694
- Sponsor's protocol ID
- 4-2011-0181
- Status last verified
- Jun 2012
- First submitted
- 5 Jun 2012
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee B, Lee JR, Na S. Targeting smooth emergence: the effect site concentration of remifentanil for preventing cough during emergence during propofol-remifentanil anaesthesia for thyroid surgery. Br J Anaesth. 2009 Jun;102(6):775-8. doi: 10.1093/bja/aep090. Epub 2009 May 2.
PubMed 19411668Guler G, Akin A, Tosun Z, Eskitascoglu E, Mizrak A, Boyaci A. Single-dose dexmedetomidine attenuates airway and circulatory reflexes during extubation. Acta Anaesthesiol Scand. 2005 Sep;49(8):1088-91. doi: 10.1111/j.1399-6576.2005.00780.x.
PubMed 16095449Turan G, Ozgultekin A, Turan C, Dincer E, Yuksel G. Advantageous effects of dexmedetomidine on haemodynamic and recovery responses during extubation for intracranial surgery. Eur J Anaesthesiol. 2008 Oct;25(10):816-20. doi: 10.1017/S0265021508004201. Epub 2008 Apr 10.
PubMed 18400140Nho JS, Lee SY, Kang JM, Kim MC, Choi YK, Shin OY, Kim DS, Kwon MI. Effects of maintaining a remifentanil infusion on the recovery profiles during emergence from anaesthesia and tracheal extubation. Br J Anaesth. 2009 Dec;103(6):817-21. doi: 10.1093/bja/aep307. Epub 2009 Oct 28.
PubMed 19864308
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Remifentanil Target-controlled Infusion and Dexmedetomidine Bolus Administration for Smooth Emergence From General Sevoflurane Anesthesia
- ClinicalTrials.gov ID
- NCT01617694
- Acronym / sponsor ID
- 4-2011-0181
- Conditions
- Thyroid Neoplasm
- Keywords
- dexmedetomidine, remifentanil, target-controlled infusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 12 Jun 2012 (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 target-controlled infusion and dexmedetomidine single-dose administration are known to reduce airway response and haemodynamic stimulation during anaesthetic recovery. The investigators will compare the effects of two drugs on prevention of cough during emergence from general sevoflurane anaesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group R | Experimental | Drug: dexmedetomidine, Drug: Normal Salinecontinuation of remifentanil target controlled infusion (TCI) at effect-site concentration of 2 ng/ml during anesthetic recovery until extubation. |
| group D | Active comparator | Drug: dexmedetomidine, Drug: Normal Salineremifentanil TCI discontinuation and dexmedetomidine 0.5 mg/kg intravenous injection before 10 min of the end of surgery |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- female patient,
- aged 20-60 yr,
- ASA physical status 1-2,
- patients undergoing elective thyroidectomy under general anesthesia
Key exclusion criteria (4 listed)
- sighs of difficult airway,
- history of respiratory disease or chronic cough,
- cardiovascular disease,
- pregnant or breast-feeding woman.
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 |
|---|---|---|
| dexmedetomidineFifteen minutes before the end of surgery, the first practitioner replace the syringe of remifentanil as new one; new syringe contains remifentanil in remifentanil group (Group R), and normal saline in dexmedetomidine group (Group D), respectively. There are no drug labeling in the new syringe, so the second practitioner can't know which drug was contained in the new syringe. Simultaneously, the second practitioner remifentanil concentration on monitor of TCI pump will be adjusted to 2.0 ng•ml-1. Ten minutes before the end of surgery, 10 ml of dexmedetomidine 0.5 mcg•kg-1 mixed with normal saline will be given for 5 min in Group D; in Group R, 10 ml of normal saline will be given by the first practitioner. | Drug | group D, group R |
| Normal Saline | Drug | group D, group R |
Primary outcome
coughing response
Time frame: from discontinuation of anesthetic agent (sevoflurane) to 5 min after extubation.
Emergence cough was defined as the cough occurrence during peri-extubation period, from sevoflurane discontinuation to 5 min after extubation. The severity of cough was assessed and recorded by the following cough grading system: Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).
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 12 Jun 2012.
- Background: PubMed 19411668Lee B, Lee JR, Na S. Targeting smooth emergence: the effect site concentration of remifentanil for preventing cough during emergence during propofol-remifentanil anaesthesia for thyroid surgery. Br J Anaesth. 2009 Jun;102(6):775-8. doi: 10.1093/bja/aep090. Epub 2009 May 2.
- Background: PubMed 16095449Guler G, Akin A, Tosun Z, Eskitascoglu E, Mizrak A, Boyaci A. Single-dose dexmedetomidine attenuates airway and circulatory reflexes during extubation. Acta Anaesthesiol Scand. 2005 Sep;49(8):1088-91. doi: 10.1111/j.1399-6576.2005.00780.x.
- Background: PubMed 18400140Turan G, Ozgultekin A, Turan C, Dincer E, Yuksel G. Advantageous effects of dexmedetomidine on haemodynamic and recovery responses during extubation for intracranial surgery. Eur J Anaesthesiol. 2008 Oct;25(10):816-20. doi: 10.1017/S0265021508004201. Epub 2008 Apr 10.
- Background: PubMed 19864308Nho JS, Lee SY, Kang JM, Kim MC, Choi YK, Shin OY, Kim DS, Kwon MI. Effects of maintaining a remifentanil infusion on the recovery profiles during emergence from anaesthesia and tracheal extubation. Br J Anaesth. 2009 Dec;103(6):817-21. doi: 10.1093/bja/aep307. Epub 2009 Oct 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine and Normal Saline in people with Thyroid Neoplasm, 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 4 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 12 Jun 2012. 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.
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?
coughing response (time frame: from discontinuation of anesthetic agent (sevoflurane) to 5 min after extubation.). 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 NCT01617694, which also lists 4 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 12 Jun 2012.