Opioid-Induced DisordersPhase 4NCT03812003
Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia
A Phase 4 study testing Remifentanil in people with Opioid-Induced Disorders, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
The concept of Enhanced Recovery After Surgery(ERAS) has been prevalent in recent years. In the ERAS guideline, short-acting anesthetics, instead of long-acting opioid anesthetics, were recommended during surgery to decrease post-operative complication and length of hospital stay. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Opioid-Induced Disorders
- What is being tested?
- Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jan 2019to 1 Feb 2020
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject's ASA (American Society of Anesthesiologists) Physical Status Classification: I (A normal healthy patient)~III(A patient with severe systemic disease)
- Subject has breast cancer and scheduled for breast surgery using total-intravenous anesthesia(TIVA)
Who cannot join
- Subject's ASA (American Society of Anesthesiologists) Physical Status Classification >3
- Subject doesn't receive total-intravenous anesthesia(TIVA) during surgery
- Subject has psychiatric disease
- allergic to opioid or propofol
- History of alcoholism
- History of drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia by Remifentanil Infusion
The concept of Enhanced Recovery After Surgery(ERAS) has been prevalent in recent years. In the ERAS guideline, short-acting anesthetics, instead of long-acting opioid anesthetics, were recommended during surgery to decrease post-operative complication and length of hospital stay. Propofol-remifentanil based total intravenous anesthesia (TIVA) can provide quicker emergence and decreased post-operative nausea and vomiting. However, the prescription of opioid (especially remifentanil) may induce opioid-induced hyperalgesia (OIH) and increase the requirement of analgesics. Previous studies provided some strategies to prevent OIH. The purpose of this study is to investigate the effect of adding remifentanil(1 mcg/kg) after emergence and endotracheal extubation in breast cancer females receiving breast surgery under propofol-remifentanil based TIVA for the prevention of OIH.
Read the detailed description
- After obtaining informed consent, patients will be randomized into two groups.
- All patients receive remifentanil-propofol based TIVA and Bispectral index (BIS) monitor during breast surgery. In the end of surgery, intravenous NSAID(keto) 30mg and local anestehsia (Marcaine) infiltration around the surgical wound will be prescribed to reduce post-operative pain.
- group R(intervention): remifentanil 1mcg/kg diluted with 0.9% saline to 50ml and drip for 30 minutes after emergence and extubation of endotracheal tube
- group N(no intervention): 0.9% saline 50ml drip for 30 minutes after emergence and extubation of endotracheal tube
- In post-anesthesia room: record the numerical rating scale (NRS); requirement of additional analgesics (rescue medication), blood pressure, heart rate, pulse oximeter, degree of nausea, vomiting
- In ward: record the numerical rating scale (NRS) and total analgesics consumption
- Conditions
- Opioid-Induced Disorders
- Being tested
- Remifentanil
- Keywords
- opioid-induced hyperalgesia, remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Remifentanil ALVOGEN powder
remifentanil 1mcg/kg added in 0.9% saline and diluted to 50ml
| Study group | Role | What they receive |
|---|---|---|
| remifentanil | Experimental | After emergence and extubation of endotracheal tube, remifentanil 1mcg/kg were diluted with 0.9% saline to 50 ml, added in IV bag, and drip for 30 minutes. Receives: Drug: Remifentanil |
| no intervention | No intervention | After emergence and extubation of endotracheal tube, 0.9% saline 50ml were added in IV bag and drip for 30 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR)
1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by Numerical Rating Scale (Numerical Rating Scale)(0-10; 0= no pain; 10=pain as bad as can be)
Measured: 0 minutes
Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR)
1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by Numerical Rating Scale (Numerical Rating Scale)(0-10; 0= no pain; 10=pain as bad as can be)
Measured: 30 minutes
The amount analgesic requirement in post-anesthesia room (PAR)
1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics during surgery. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by record additional analgesics amount (rescue medication, mg) in PAR
Measured: 30 minutes
Secondary outcomes (16)
degree of post-operative nausea in post-anesthesia room (PAR)
Record the degree of nausea in PAR: mild, moderate, severe
Measured: 30 minutes
degree of post-operative vomiting in post-anesthesia room (PAR)
Record the degree of vomiting in PAR: mild, moderate, severe
Measured: 30 minutes
post-operative blood pressure in post-anesthesia room (PAR)
Record the blood pressure(mmHg) in PAR
Measured: 0 minutes
post-operative systolic blood pressure in post-anesthesia room (PAR)
Record the systolic blood pressure(mmHg) in PAR
Measured: 0 minutes
post-operative systolic blood pressure in post-anesthesia room (PAR)
Record the systolic blood pressure(mmHg) in PAR
Measured: 30 minutes
post-operative diastolic blood pressure in post-anesthesia room (PAR)
Record the diastolic blood pressure(mmHg) in PAR
Measured: 30 minutes
post-operative heart rate in post-anesthesia room (PAR)
Record the heart rate (beat/min) in PAR
Measured: 0 minutes
post-operative heart rate in post-anesthesia room (PAR)
Record the heart rate (beat/min) in PAR
Measured: 30 minutes
post-operative pulse oximeter in post-anesthesia room (PAR)
Record the pulse oximeter(SpO2; %) in PAR
Measured: 0 minutes
postoperative pulse oximeter in post-anesthesia room (PAR)
Record the pulse oximeter(SpO2; %) in PAR
Measured: 30 minutes
Numerical Rating Score (NRS) for pain score in ward
Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)
Measured: 1 hour after transferring to ward
Numerical Rating Score (NRS) for pain score in ward
Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)
Measured: 2 hours after transferring to ward
Numerical Rating Score (NRS) for pain score in ward
Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)
Measured: 4 hours after transferring to ward
Numerical Rating Score (NRS) for pain score in ward
Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)
Measured: 8 hours after transferring to ward
Numerical Rating Score (NRS) for pain score in ward
Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)
Measured: 24 hours after transferring to ward
total analgesics requirement in ward
Record total analgesic requirement (mg) in ward
Measured: 24hr after transferring to ward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start11 Jan 2019
- Primary completion31 Dec 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Induced DisordersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Breast cancer patient
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Hung Chan, Tri-Service General Hospital (TSGH)
- Investigators
- Jyh-cherng Yu, MD, Study chair, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812003
- Sponsor's protocol ID
- 2-107-05-162
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2019
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Numerical rating scale, rescue analgesic amount
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia by Remifentanil Infusion
- ClinicalTrials.gov ID
- NCT03812003
- Acronym / sponsor ID
- 2-107-05-162
- Conditions
- Opioid-Induced Disorders
- Keywords
- opioid-induced hyperalgesia, remifentanil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 22 Jan 2019 (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 concept of Enhanced Recovery After Surgery(ERAS) has been prevalent in recent years. In the ERAS guideline, short-acting anesthetics, instead of long-acting opioid anesthetics, were recommended during surgery to decrease post-operative complication and length of hospital stay. Propofol-remifentanil based total intravenous anesthesia (TIVA) can provide quicker emergence and decreased post-operative nausea and vomiting. However, the prescription of opioid (especially remifentanil) may induce opioid-induced hyperalgesia (OIH) and increase the requirement of analgesics. Previous studies provided some strategies to prevent OIH. The purpose of this study is to investigate the effect of adding remifentanil(1 mcg/kg) after emergence and endotracheal extubation in breast cancer females receiving breast surgery under propofol-remifentanil based TIVA for the prevention of OIH.
Detailed description
- After obtaining informed consent, patients will be randomized into two groups.
- All patients receive remifentanil-propofol based TIVA and Bispectral index (BIS) monitor during breast surgery. In the end of surgery, intravenous NSAID(keto) 30mg and local anestehsia (Marcaine) infiltration around the surgical wound will be prescribed to reduce post-operative pain.
- group R(intervention): remifentanil 1mcg/kg diluted with 0.9% saline to 50ml and drip for 30 minutes after emergence and extubation of endotracheal tube
- group N(no intervention): 0.9% saline 50ml drip for 30 minutes after emergence and extubation of endotracheal tube
- In post-anesthesia room: record the numerical rating scale (NRS); requirement of additional analgesics (rescue medication), blood pressure, heart rate, pulse oximeter, degree of nausea, vomiting
- In ward: record the numerical rating scale (NRS) and total analgesics consumption
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Breast cancer patient
| Arm | Type | Receives |
|---|---|---|
| remifentanil | Experimental | Drug: RemifentanilAfter emergence and extubation of endotracheal tube, remifentanil 1mcg/kg were diluted with 0.9% saline to 50 ml, added in IV bag, and drip for 30 minutes. |
| no intervention | No intervention | –After emergence and extubation of endotracheal tube, 0.9% saline 50ml were added in IV bag and drip for 30 minutes. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject's ASA (American Society of Anesthesiologists) Physical Status Classification: I (A normal healthy patient)~III(A patient with severe systemic disease)
- Subject has breast cancer and scheduled for breast surgery using total-intravenous anesthesia(TIVA)
Key exclusion criteria (6 listed)
- Subject's ASA (American Society of Anesthesiologists) Physical Status Classification >3
- Subject doesn't receive total-intravenous anesthesia(TIVA) during surgery
- Subject has psychiatric disease
- allergic to opioid or propofol
- History of alcoholism
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: Remifentanil ALVOGEN powderremifentanil 1mcg/kg added in 0.9% saline and diluted to 50ml | Drug | remifentanil |
Primary outcome
Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR)
Time frame: 0 minutes
1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by Numerical Rating Scale (Numerical Rating Scale)(0-10; 0= no pain; 10=pain as bad as can be)
Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR)
Time frame: 30 minutes
1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by Numerical Rating Scale (Numerical Rating Scale)(0-10; 0= no pain; 10=pain as bad as can be)
The amount analgesic requirement in post-anesthesia room (PAR)
Time frame: 30 minutes
1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics during surgery. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by record additional analgesics amount (rescue medication, mg) in PAR
16 secondary outcomes
degree of post-operative nausea in post-anesthesia room (PAR)
Time frame: 30 minutes
degree of post-operative vomiting in post-anesthesia room (PAR)
Time frame: 30 minutes
post-operative blood pressure in post-anesthesia room (PAR)
Time frame: 0 minutes
post-operative systolic blood pressure in post-anesthesia room (PAR)
Time frame: 0 minutes
post-operative systolic blood pressure in post-anesthesia room (PAR)
Time frame: 30 minutes
post-operative diastolic blood pressure in post-anesthesia room (PAR)
Time frame: 30 minutes
post-operative heart rate in post-anesthesia room (PAR)
Time frame: 0 minutes
post-operative heart rate in post-anesthesia room (PAR)
Time frame: 30 minutes
post-operative pulse oximeter in post-anesthesia room (PAR)
Time frame: 0 minutes
postoperative pulse oximeter in post-anesthesia room (PAR)
Time frame: 30 minutes
Numerical Rating Score (NRS) for pain score in ward
Time frame: 1 hour after transferring to ward
Numerical Rating Score (NRS) for pain score in ward
Time frame: 2 hours after transferring to ward
Numerical Rating Score (NRS) for pain score in ward
Time frame: 4 hours after transferring to ward
Numerical Rating Score (NRS) for pain score in ward
Time frame: 8 hours after transferring to ward
Numerical Rating Score (NRS) for pain score in ward
Time frame: 24 hours after transferring to ward
total analgesics requirement in ward
Time frame: 24hr after transferring to ward
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 27 Feb 2026.
- Individual participant dataSharing planned: Undecided. Numerical rating scale, rescue analgesic amount
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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.
Jyh-cherng Yu, MD study chair
Tri-Service General Hospital (TSGH)
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 Opioid-Induced Disorders, 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 2 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 27 Feb 2026. 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.
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?
Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR) (time frame: 0 minutes). The study lists 3 primary outcomes in all. 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 Feb 2026.