Postoperative PainPAGAP1NCT07353983
Pharmacokinetic Evaluation of Anrikefon Injection in the Geriatric Population With the Management of Acute Pain Following Abdominal Laparoscopy
A study testing Inject Anrikefon Injection in people with Postoperative Pain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
This study used a single-center, single-arm, pharmacokinetic ( PK ) study design. Thirty subjects who met the inclusion criteria were stratified according to age, including 15 in each age group of 65-74 years old and ≥ 75 years old. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Inject Anrikefon Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years, gender unrestricted;
- American Society of Anesthesiologists (ASA) classification I-III;
- 18 kg/m2 ≤ BMI < 30 kg/m2;
- Undergoing elective general anesthesia for laparoscopic surgery and expected to experience mild to moderate postoperative pain;
- Agree to participate in this trial and voluntarily sign the informed consent form.
Who cannot join
- There is a history or evidence of any of the following diseases before screening:1) History of cardiovascular diseases: Uncontrolled hypertension (systolic blood pressure ≥160 MMHG and/or diastolic blood pressure ≥90mmHg), as well as a history of cardiovascular diseases evaluated by the researcher as unsuitable for participation in the study, such as severe arrhythmia, heart failure, acute myocardial ischemia, unstable angina pectoris, myocardial infarction, II-III degree atrioventricular block, etc.2) Respiratory system history: Severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, and other respiratory system histories assessed by the researcher as unsuitable for participation in the study;3) History of neurological and mental system diseases: Craniocerebral injury, intracranial hypertension, schizophrenia, mania, cognitive dysfunction, etc., evaluated by the researcher as unsuitable for participation in the study;4) History of digestive system diseases: Suffering from intestinal obstruction or other digestive system diseases that the researcher deems may cause nausea and vomiting;5) Accompanied by a clear history of chronic dizziness, or clearly diagnosed vestibular dysfunction other than motion sickness (including but not limited to: peripheral vestibular syndrome, central vestibular syndrome, etc.);6) Tumor patients who have received chemotherapy and/or radiotherapy within 4 weeks prior to being informed.
- It is expected that tracheal intubation will continue after the operation or a nasal or oral gastric tube will need to be inserted.
- Known to be allergic or contraindicated to opioid drugs and other anesthetics and antiemetic drugs that may be used during the trial;
- Within 3 months prior to screening, there is a history of drug abuse, or continuous use of opioid analgesics for more than 10 days for any reason;
- Abnormal liver and kidney functions:1) Prothrombin time (PT) is prolonged by more than 3 seconds beyond the upper limit of the normal value;2) Alanine aminotransferase and/or aspartate aminotransferase > 2×ULN;3) Total bilirubin > 1.5×ULN;4) Glomerular filtration rate (eGFR) < 60 mL/min.
- Have participated in any clinical researchers within the three months prior to the screening;
- Pregnant and lactating women who have plans to become pregnant during the study period or within 3 months after the study ends;
- Subjects who the researchers consider to have any other factors that make them unsuitable for participating in this clinical study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study used a single-center, single-arm, pharmacokinetic ( PK ) study design. Thirty subjects who met the inclusion criteria were stratified according to age, including 15 in each age group of 65-74 years old and ≥ 75 years old. The patients were treated with a unified anesthesia method during abdominal endoscopic surgery. Anrecofin injection 1.0 μg / kg was injected for the first time within 15 min, and then once again at 8 h and 16 h. And received 6 pain assessments, 1 satisfaction score and 1 telephone follow-up. In this study, 10 blood samples were collected and analyzed.
- Conditions
- Postoperative Pain
- Being tested
- Inject Anrikefon Injection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inject Anrikefon InjectionDrug
After the end of the operation ( the end of the last needle suture ), the researchers need to give the subjects 1.0μg / kg of Anrikefon Injection for the first time as soon as possible ( within 15 minutes ) ( 1ml of Anrikefon Injection stock solution was diluted to 10ml, and then the dose was calculated according to the body weight, and the corresponding volume was extracted, and the injection was completed in about 2 minutes ).
| Study group | Role | What they receive |
|---|---|---|
| The age group of 65 to 74 years old | Experimental | Not described Receives: Drug: Inject Anrikefon Injection |
| Age group ≥75 years old | Experimental | Not described Receives: Drug: Inject Anrikefon Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentration
Determine the blood concentration of the Anrikefon using liquid chromatography technology.
Measured: The blood collection time points were Minute 0, Minute 2, Minute 5, Minute 10, Minute 30, Hour 1, Hour 2, Hour 4, Hour 8, Hour 12 after the 3rd intravenous injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion22 Jan 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353983
- Sponsor's protocol ID
- 2025 1539
- Acronym
- PAGAP1
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Evaluation of Anrikefon Injection in the Geriatric Population With the Management of Acute Pain Following Abdominal Laparoscopy
- ClinicalTrials.gov ID
- NCT07353983
- Acronym / sponsor ID
- PAGAP1 / 2025 1539
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 22 Jan 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Jan 2026 (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.
This study used a single-center, single-arm, pharmacokinetic ( PK ) study design. Thirty subjects who met the inclusion criteria were stratified according to age, including 15 in each age group of 65-74 years old and ≥ 75 years old. The patients were treated with a unified anesthesia method during abdominal endoscopic surgery. Anrecofin injection 1.0 μg / kg was injected for the first time within 15 min, and then once again at 8 h and 16 h. And received 6 pain assessments, 1 satisfaction score and 1 telephone follow-up. In this study, 10 blood samples were collected and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The age group of 65 to 74 years old | Experimental | Drug: Inject Anrikefon Injection |
| Age group ≥75 years old | Experimental | Drug: Inject Anrikefon Injection |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥ 65 years, gender unrestricted;
- American Society of Anesthesiologists (ASA) classification I-III;
- 18 kg/m2 ≤ BMI < 30 kg/m2;
- Undergoing elective general anesthesia for laparoscopic surgery and expected to experience mild to moderate postoperative pain;
- Agree to participate in this trial and voluntarily sign the informed consent form.
Key exclusion criteria (8 listed)
- There is a history or evidence of any of the following diseases before screening:1) History of cardiovascular diseases: Uncontrolled hypertension (systolic blood pressure ≥160 MMHG and/or diastolic blood pressure ≥90mmHg), as well as a history of cardiovascular diseases evaluated by the researcher as unsuitable for participation in the study, such as severe arrhythmia, heart failure, acute myocardial ischemia, unstable angina pectoris, myocardial infarction, II-III degree atrioventricular block, etc.2) Respiratory system history: Severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, and other respiratory system histories assessed by the researcher as unsuitable for participation in the study;3) History of neurological and mental system diseases: Craniocerebral injury, intracranial hypertension, schizophrenia, mania, cognitive dysfunction, etc., evaluated by the researcher as unsuitable for participation in the study;4) History of digestive system diseases: Suffering from intestinal obstruction or other digestive system diseases that the researcher deems may cause nausea and vomiting;5) Accompanied by a clear history of chronic dizziness, or clearly diagnosed vestibular dysfunction other than motion sickness (including but not limited to: peripheral vestibular syndrome, central vestibular syndrome, etc.);6) Tumor patients who have received chemotherapy and/or radiotherapy within 4 weeks prior to being informed.
- It is expected that tracheal intubation will continue after the operation or a nasal or oral gastric tube will need to be inserted.
- Known to be allergic or contraindicated to opioid drugs and other anesthetics and antiemetic drugs that may be used during the trial;
- Within 3 months prior to screening, there is a history of drug abuse, or continuous use of opioid analgesics for more than 10 days for any reason;
- Abnormal liver and kidney functions:1) Prothrombin time (PT) is prolonged by more than 3 seconds beyond the upper limit of the normal value;2) Alanine aminotransferase and/or aspartate aminotransferase > 2×ULN;3) Total bilirubin > 1.5×ULN;4) Glomerular filtration rate (eGFR) < 60 mL/min.
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 |
|---|---|---|
| Inject Anrikefon InjectionAfter the end of the operation ( the end of the last needle suture ), the researchers need to give the subjects 1.0μg / kg of Anrikefon Injection for the first time as soon as possible ( within 15 minutes ) ( 1ml of Anrikefon Injection stock solution was diluted to 10ml, and then the dose was calculated according to the body weight, and the corresponding volume was extracted, and the injection was completed in about 2 minutes ). | Drug | Age group ≥75 years old, The age group of 65 to 74 years old |
Primary outcome
Blood concentration
Time frame: The blood collection time points were Minute 0, Minute 2, Minute 5, Minute 10, Minute 30, Hour 1, Hour 2, Hour 4, Hour 8, Hour 12 after the 3rd intravenous injection.
Determine the blood concentration of the Anrikefon using liquid chromatography technology.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Inject Anrikefon Injection in people with Postoperative Pain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dai, Professor (86-571-87783891, haibindai@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood concentration (time frame: The blood collection time points were Minute 0, Minute 2, Minute 5, Minute 10, Minute 30, Hour 1, Hour 2, Hour 4, Hour 8, Hour 12 after the 3rd intravenous injection.). 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 21 Jan 2026.