HyperalgesiaNCT04387097
Drip-infusion of Remifentanil for RIH
An observational study of Hyperalgesia, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
The development of remifentanil-induced hyperalgesia (RIH) is an unpleasant experience for surgical patients. An alternative management, gradual withdrawal of remifentanil was effective in prevention of RIH. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hyperalgesia
- What is being tested?
- remifentanil
- Type of treatment
- Injection or infusion
- How many people
- 559 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2018to 22 Jul 2019
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients receiving surgery with age between 20-80 years
Who may be able to join
- American Society of Anesthesiologists (ASA) score of I-III patients receiving total intravenous anesthesia
Who cannot join
- The use of inhalation agents or propofol combined with inhalation anesthesia
- Pregnancy
- Previous substance abuse
- Known allergies to opioids, propofol or any drugs used in the study
- History of neuropsychiatric disorder
- Age < 20 years or > 80 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Drip-infusion of Remifentanil for Preventing Remifentanil-induced Hyperalgesia- a Retrospective Observative Study
The development of remifentanil-induced hyperalgesia (RIH) is an unpleasant experience for surgical patients. An alternative management, gradual withdrawal of remifentanil was effective in prevention of RIH. The investigators designed a simple modality to assess if under withdrawal of remifentanil and further drip-infusion of remifentanil immediately after extubation affected postoperative pain score, the requirement of rescue analgesics, and adverse effects.
Read the detailed description
In clinical practice, the gradual withdrawal of remifentanil during surgery is unsatisfied. Thus, the investigators conducted a simple modality in a single center retrospective cohort study to assess how under baseline gradual withdrawal of remifentanil and further drip infusion of remifentanil immediately after extubation affected postoperative pain score and use of analgesics.
- Conditions
- Hyperalgesia
- Being tested
- remifentanil
- Keywords
- Remifentanil, Hyperalgesia, Drip-infusion
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanilDrug
Also called drip-infusion
postoperative drip-infusion of remifentanil
| Study group | Role | What they receive |
|---|---|---|
| gradual withdrawal following by drip-infusion of remifentanil | In the end of the surgery, gradual withdrawal of remifentanil was prescribed until the endotracheal tube was extubated. Following by drip-infusion of remifentanil for 30 minutes was administered immediately after tracheal extubation. Receives: Drug: remifentanil | |
| gradual withdrawal of remifentanil | In the end of the surgery, gradual withdrawal of remifentanil was prescribed until the endotracheal tube was extubated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of the numeric rating scale (NRS) between 2 groups
NRS scores is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.
Measured: one hour
requirement for rescue analgesics
postoperative requirement for rescue analgesics
Measured: one hour
Secondary outcomes (2)
type of surgery
type of surgery in both groups
Measured: three hours
surgical site
surgical site in both groups
Measured: three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 May 2018
- Primary completion31 Jan 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 559 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-hsuan Huang, Tri-Service General Hospital (TSGH)
- Investigators
- Yi-hsuan Huang, MD, Principal investigator, Tri-Service General Hospital and National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387097
- Sponsor's protocol ID
- TSGHIRB No: 2-108-05-135
- Status last verified
- May 2020
- First submitted
- 8 May 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Comelon M, Raeder J, Stubhaug A, Nielsen CS, Draegni T, Lenz H. Gradual withdrawal of remifentanil infusion may prevent opioid-induced hyperalgesia. Br J Anaesth. 2016 Apr;116(4):524-30. doi: 10.1093/bja/aev547. Epub 2016 Mar 1.
PubMed 26934941Saxena S, Gonsette K, Terram W, Huybrechts I, Nahrwold DA, Cappello M, Barvais L, Engelman E. Gradual withdrawal of remifentanil delays initial post-operative analgesic demand after thyroid surgery; double-blinded, randomized controlled trial. BMC Anesthesiol. 2019 Apr 25;19(1):60. doi: 10.1186/s12871-019-0731-9.
PubMed 31027480
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Drip-infusion of Remifentanil for Preventing Remifentanil-induced Hyperalgesia- a Retrospective Observative Study
- ClinicalTrials.gov ID
- NCT04387097
- Acronym / sponsor ID
- TSGHIRB No: 2-108-05-135
- Conditions
- Hyperalgesia
- Keywords
- Remifentanil, Hyperalgesia, Drip-infusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 559 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 13 May 2020 (actual)
- 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 development of remifentanil-induced hyperalgesia (RIH) is an unpleasant experience for surgical patients. An alternative management, gradual withdrawal of remifentanil was effective in prevention of RIH. The investigators designed a simple modality to assess if under withdrawal of remifentanil and further drip-infusion of remifentanil immediately after extubation affected postoperative pain score, the requirement of rescue analgesics, and adverse effects.
Detailed description
In clinical practice, the gradual withdrawal of remifentanil during surgery is unsatisfied. Thus, the investigators conducted a simple modality in a single center retrospective cohort study to assess how under baseline gradual withdrawal of remifentanil and further drip infusion of remifentanil immediately after extubation affected postoperative pain score and use of analgesics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gradual withdrawal following by drip-infusion of remifentanil | – | Drug: remifentanilIn the end of the surgery, gradual withdrawal of remifentanil was prescribed until the endotracheal tube was extubated. Following by drip-infusion of remifentanil for 30 minutes was administered immediately after tracheal extubation. |
| gradual withdrawal of remifentanil | – | –In the end of the surgery, gradual withdrawal of remifentanil was prescribed until the endotracheal tube was extubated. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients receiving surgery with age between 20-80 years
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) score of I-III patients receiving total intravenous anesthesia
Key exclusion criteria (6 listed)
- The use of inhalation agents or propofol combined with inhalation anesthesia
- Pregnancy
- Previous substance abuse
- Known allergies to opioids, propofol or any drugs used in the study
- History of neuropsychiatric 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 |
|---|---|---|
| remifentanilAlso: drip-infusionpostoperative drip-infusion of remifentanil | Drug | gradual withdrawal following by drip-infusion of remifentanil |
Primary outcome
comparison of the numeric rating scale (NRS) between 2 groups
Time frame: one hour
NRS scores is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.
requirement for rescue analgesics
Time frame: one hour
postoperative requirement for rescue analgesics
2 secondary outcomes
type of surgery
Time frame: three hours
surgical site
Time frame: three hours
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 15 May 2020.
- Results publication: PubMed 26934941Comelon M, Raeder J, Stubhaug A, Nielsen CS, Draegni T, Lenz H. Gradual withdrawal of remifentanil infusion may prevent opioid-induced hyperalgesia. Br J Anaesth. 2016 Apr;116(4):524-30. doi: 10.1093/bja/aev547. Epub 2016 Mar 1.
- Results publication: PubMed 31027480Saxena S, Gonsette K, Terram W, Huybrechts I, Nahrwold DA, Cappello M, Barvais L, Engelman E. Gradual withdrawal of remifentanil delays initial post-operative analgesic demand after thyroid surgery; double-blinded, randomized controlled trial. BMC Anesthesiol. 2019 Apr 25;19(1):60. doi: 10.1186/s12871-019-0731-9.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Yi-hsuan Huang, MD principal investigator
Tri-Service General Hospital and National Defense Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperalgesia, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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 1 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: finished, as of the sponsor's last update on 15 May 2020. 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 Taiwan. 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?
comparison of the numeric rating scale (NRS) between 2 groups (time frame: one hour). 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?
On the ClinicalTrials.gov record for NCT04387097, which also lists 2 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 15 May 2020.