HyperalgesiaPhase 4NCT01189721
Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery
A Phase 4 study testing propofol, sevoflurane in people with Hyperalgesia, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
The investigators hypothesize that propofol infusion during surgery can affect the remifentanil hyperalgesia compared to sevoflurane inhalation.The outcome will be measured by a verbal numerical rating score (VNRS) and mechanical punctuating pain by electronic von frey filament. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hyperalgesia
- What is being tested?
- propofol, sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Jul 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing thyroidectomy
- Age 20-65
- American Society of Anesthesiologists physical status classification I or II
Who cannot join
- History of chronic pain, Regular use of analgesic, antiepileptic or antidepressive drugs
- History of drug \& alcohol abuse
- Psychiatric disorder
- Use of opioids within 24hrs
- Renal disease with decreased glomerular filtrate ratio
- Neuromuscular disease, Severe cardiac disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gang Nam Severance Hospital, Yonsei University, Anesthesia and Pain Medicine Department,
Seoul, 135-270
young ju won, MD, 082-2-2019-6805, moma2@naver.com
young ju won, MD
About this study
The investigators hypothesize that propofol infusion during surgery can affect the remifentanil hyperalgesia compared to sevoflurane inhalation.The outcome will be measured by a verbal numerical rating score (VNRS) and mechanical punctuating pain by electronic von frey filament.
- Conditions
- Hyperalgesia
- Being tested
- propofol, sevoflurane
- Keywords
- remifentanil, hyperalgesia
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol, sevofluraneDrug
Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min (group1 and 2) group 1 (Active Comparator, sevoflurane)will be infused propofol intraoperatively.
group 2(Experimental, propofol) will be inhaled sevoflurane intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane | Active comparator | Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients who are in this group will be infused propofol intraoperatively. Receives: Drug: propofol, sevoflurane |
| propofol | Experimental | Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients included this group will be inhaled sevoflurane intraoperatively. Receives: Drug: propofol, sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tactile pain thresholds adjacent to the surgical wound assessed by von Frey hair before the induction and at postoperative 24 & 48 hrs
Measured: postoperative 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperalgesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Investigators
- yuen hee shim, MD, Study chair, Gangnam severance hospital, Yonsei university, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Reseach Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189721
- Sponsor's protocol ID
- 3-2010-0102
- Status last verified
- Aug 2010
- First submitted
- 25 Aug 2010
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery
- ClinicalTrials.gov ID
- NCT01189721
- Acronym / sponsor ID
- 3-2010-0102
- Conditions
- Hyperalgesia
- Keywords
- remifentanil, hyperalgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 27 Aug 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 investigators hypothesize that propofol infusion during surgery can affect the remifentanil hyperalgesia compared to sevoflurane inhalation.The outcome will be measured by a verbal numerical rating score (VNRS) and mechanical punctuating pain by electronic von frey filament.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sevoflurane | Active comparator | Drug: propofol, sevofluraneRemifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients who are in this group will be infused propofol intraoperatively. |
| propofol | Experimental | Drug: propofol, sevofluraneRemifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients included this group will be inhaled sevoflurane intraoperatively. |
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 thyroidectomy
- Age 20-65
- American Society of Anesthesiologists physical status classification I or II
Key exclusion criteria (6 listed)
- History of chronic pain, Regular use of analgesic, antiepileptic or antidepressive drugs
- History of drug \& alcohol abuse
- Psychiatric disorder
- Use of opioids within 24hrs
- Renal disease with decreased glomerular filtrate ratio
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 |
|---|---|---|
| propofol, sevofluraneRemifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min (group1 and 2) group 1 (Active Comparator, sevoflurane)will be infused propofol intraoperatively. group 2(Experimental, propofol) will be inhaled sevoflurane intraoperatively. | Drug | propofol, sevoflurane |
Primary outcome
Tactile pain thresholds adjacent to the surgical wound assessed by von Frey hair before the induction and at postoperative 24 & 48 hrs
Time frame: postoperative 48 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
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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 study chair
Gangnam severance hospital, Yonsei university, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Reseach Institute
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 propofol, sevoflurane in people with Hyperalgesia, run by Gangnam Severance Hospital 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 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: status not confirmed, as of the sponsor's last update on 27 Aug 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact young ju won, MD. (082-2-2019-6805, moma2@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tactile pain thresholds adjacent to the surgical wound assessed by von Frey hair before the induction and at postoperative 24 & 48 hrs (time frame: postoperative 48 hrs). 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 27 Aug 2010.