EpigeneticsPhase 4NCT03135795
The Epigenetic Modification in OPRM1 on Postoperative Analgesia and Side Effect Induced by Sufentanil
A Phase 4 study testing Sufentanil, dexmedetomidine and propofol in people with Epigenetics, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
To explore the epigenetic mechanism of postoperative analgesia and side effect induced by μ-opioid Receptor Agonists presented with sufentanil among general population. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Epigenetics
- What is being tested?
- Sufentanil, dexmedetomidine and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2017to 31 May 2017
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status Ⅰ-Ⅱ ;
- Weight 50-75 kg;
Who cannot join
- Long history of alcohol or analgesic drugs(including opioid ) abuse;
- Heavy smoking;
- Motion sickness;
- Long history of PONV;
- Chronic pain;
- Complicated with severe heart、brain or kidney disease.
Trial locations and contacts
1 site in 1 country.
Xu Hui contact
China1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Ai Ling, +8613667135571, aileen911@126.com
Xu Hui, +8613971001596
About this study
Official title: The Influence of Epigenetic Modification in OPRM1 on Postoperative Analgesia and Side Effect Induced by μ-opioid Receptor Agonists
To explore the epigenetic mechanism of postoperative analgesia and side effect induced by μ-opioid Receptor Agonists presented with sufentanil among general population.
Read the detailed description
Patients were interviewed the day before surgery, and taught about the use of PCA pump and VAS. Pressure pain threshold(PPT) and pressure pain tolerance(PTO) were collected before surgery.
Dexmedetomidine1μg/Kg，sufentanil 0.5μg/Kg， propofol 2mg/Kg and rocuronium 0.6mg/Kg were given intravenously for induction. Anesthesia was maintained with inhalation of 1% sevoflurane and infusion of remifentanil (0.2-0.4ug/kg/min) and propofol (6-10mg/kg/h). Aterial blood pressure(ABP)，central venous pressure(CVP)，SPO2， HR，ETCO2，T and Narcotrend were monitored. Before incision, parecoxib 40mg was given intravenously, and PCA with sufentanil 1ug/ml was started immediately after surgery, suing a controlled infusion pump. The pump was programmed to use a loading dose of 2ml, background infusion at 2m/h, PCA dose of 1ml, lockout time of 10min, and maximal dose of 12ml with 1 h period.
VAS(static), VAS(dynamic), Ramssay, HR, NBP, SpO2, PCA pressing frequency, PCA comsumption were recorded 6h, 12h, 24h, 48h after surgery. Side effects such as nausea, vomiting, respiratory depression; pruritus; abdominal distention; urinary retention and dizziness were also recorded, and corresponding treatment were given.
EDTA anti-coagulated blood was collected from a central venous catheter during the operation. Genomic DNA was extracted from the blood samples, and characteristics and degree of DNA methylation of the gene OPRM1 were analysed.
- Conditions
- Epigenetics
- Being tested
- Sufentanil, dexmedetomidine, propofol, Rocuronium, sevoflurane
- Keywords
- sufentanil, DNA methylation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
Also called Sufentanil Citrate Injection
Patients received intravenous sufentanil 0.5μg/kg for induction,and received PCA after surgery with sufentanil 1ug/ml using a controlled infusion pump, which was programmed to use a loading dose of 2ml, background infusion at 2m/h, PCA dose of 1ml, lockout time of 10min, and maximal dose of 12ml within 1 hour period.
dexmedetomidineDrug
Also called Dexmedetomidine Hydrochloride Injection
Patients received intravenous dexmedetomidine 1μg/Kg for induction.
propofolDrug
Also called propofol injection
Patients received intravenous propofol 2mg/Kg for induction, and received intavenous pump of propofol (0.3-0.6mg/kg/h) for maintenance.
RocuroniumDrug
Also called Rocuronium Bromide Injection
Patients received intravenous rocuronium 0.6mg/Kg for induction.
sevofluraneDrug
Patients received inhalation of sevoflurane (1-2%) for maintenance.
remifentanilDrug
Also called remifentanil Citrate Injection
Patients received intavenous pump of remifentanil (0.1-0.2ug/kg/min) for maintenance.
ParecoxibDrug
Also called Dynastat
Parecoxib 40mg was given single intravenously before incision.
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing pancreatectomy | Experimental | patients undergoing pancreatectomy received dexmedetomidine 1μg/Kg，sufentanil 0.5μg/Kg， propofol 2mg/Kg，rocuronium 0.6mg/Kg for induction.And received sevoflurane(1-2%), remifentanil(0.1-0.2ug/kg/min) and propofol(0.3-0.6mg/kg/h) for maintenance. Parecoxib 40mg was given single intravenously before incision. And PCA with sufentanil 1ug/ml was started immediately after surgery. Receives: Drug: Sufentanil; Drug: dexmedetomidine; Drug: propofol; Drug: Rocuronium; Drug: sevoflurane; Drug: remifentanil; Drug: Parecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of methylation in CpG islands located in gene OPRM1
EDTA anti-coagulated blood was collected before induction. Genomic DNA was extracted according to the manufacturer's protocol, and CpG islands in the OPRM1 gene region were identified by CpG Island Explorer 2.0 software. Quantification of DNA methylation of all CpG sites from position +528 to +1649 in CpG islands was analysed.
Measured: 3 months
Secondary outcomes (14)
Pressure pain threshold (PPT) and pressure pain tolerance (PTO)
Patients' Pressure pain threshold(PPT) and pressure pain tolerance(PTO) in Kg/cm2 were measured before surgery using electronic pressure algometer (YISIDA-DS2, Hongkong, China).
Measured: 1 day
Sex
Patients' sex (male or female) was recorded before surgery.
Measured: 1 day
Age
Patients' age in years was recorded before surgery.
Measured: 1 day
Weight
Patients' weight in kilograms was recorded before surgery.
Measured: 1 day
Height
Patients' height in meters was recorded before surgery.
Measured: 1 day
History of smoking
Patients' history of smoking (yes or no) was recorded before surgery.
Measured: 1 day
VAS (static) and VAS (dynamic)
Patients' VAS(static) and VAS(dynamic) score (range 0-10) were recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.
Measured: 6hours, 12hours, 24hours, 48hours after surgery.
Ramssay
Patients' Ramssay score (range 1-6) was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.
Measured: 6hours, 12hours, 24hours, 48hours after surgery.
Heart rate (HR)
Patients' HR in bpm was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.
Measured: 6hours, 12hours, 24hours, 48hours after surgery
Blood pressure (BP)
Patients' BP in mmHg was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.
Measured: 6hours, 12hours, 24hours, 48hours after surgery.
Pulse oxygen saturation (SpO2)
Patients' SpO2 in percent was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.
Measured: 6hours, 12hours, 24hours, 48hours after surgery.
PCA pressing frequency
Patients' PCA pressing frequency in time was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.
Measured: 6hours, 12hours, 24hours, 48hours after surgery
PCA consumption
Patients' PCA consumption in ml was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.
Measured: 6hours, 12hours, 24hours, 48hours after surgery
Side effects
Side effects such as nausea, vomiting, respiratory depression, pruritus, abdominal distention, urinary retention and dizziness (yes or no) were recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery, and corresponding treatment were given.
Measured: 6hours, 12hours, 24hours, 48hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start6 Feb 2017
- Primary completion31 May 2017 (estimated)
- Study completion31 May 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpigeneticsStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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 4
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ai Ling, Huazhong University of Science and Technology
- Investigators
- Xu Hui, Study chair, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135795
- Sponsor's protocol ID
- ALing
- Status last verified
- Apr 2017
- First submitted
- 1 Mar 2017
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Epigenetic Modification in OPRM1 on Postoperative Analgesia and Side Effect Induced by μ-opioid Receptor Agonists
- ClinicalTrials.gov ID
- NCT03135795
- Acronym / sponsor ID
- ALing
- Conditions
- Epigenetics
- Keywords
- sufentanil, DNA methylation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 31 May 2017 (estimated)
- Study completion
- 31 May 2017 (estimated)
- First posted
- 1 May 2017 (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.
To explore the epigenetic mechanism of postoperative analgesia and side effect induced by μ-opioid Receptor Agonists presented with sufentanil among general population.
Detailed description
Patients were interviewed the day before surgery, and taught about the use of PCA pump and VAS. Pressure pain threshold(PPT) and pressure pain tolerance(PTO) were collected before surgery.
Dexmedetomidine1μg/Kg，sufentanil 0.5μg/Kg， propofol 2mg/Kg and rocuronium 0.6mg/Kg were given intravenously for induction. Anesthesia was maintained with inhalation of 1% sevoflurane and infusion of remifentanil (0.2-0.4ug/kg/min) and propofol (6-10mg/kg/h). Aterial blood pressure(ABP)，central venous pressure(CVP)，SPO2， HR，ETCO2，T and Narcotrend were monitored. Before incision, parecoxib 40mg was given intravenously, and PCA with sufentanil 1ug/ml was started immediately after surgery, suing a controlled infusion pump. The pump was programmed to use a loading dose of 2ml, background infusion at 2m/h, PCA dose of 1ml, lockout time of 10min, and maximal dose of 12ml with 1 h period.
VAS(static), VAS(dynamic), Ramssay, HR, NBP, SpO2, PCA pressing frequency, PCA comsumption were recorded 6h, 12h, 24h, 48h after surgery. Side effects such as nausea, vomiting, respiratory depression; pruritus; abdominal distention; urinary retention and dizziness were also recorded, and corresponding treatment were given.
EDTA anti-coagulated blood was collected from a central venous catheter during the operation. Genomic DNA was extracted from the blood samples, and characteristics and degree of DNA methylation of the gene OPRM1 were analysed.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing pancreatectomy | Experimental | Drug: Sufentanil, Drug: dexmedetomidine, Drug: propofol, Drug: Rocuronium, Drug: sevoflurane, Drug: remifentanil, Drug: Parecoxibpatients undergoing pancreatectomy received dexmedetomidine 1μg/Kg，sufentanil 0.5μg/Kg， propofol 2mg/Kg，rocuronium 0.6mg/Kg for induction.And received sevoflurane(1-2%), remifentanil(0.1-0.2ug/kg/min) and propofol(0.3-0.6mg/kg/h) for maintenance. Parecoxib 40mg was given single intravenously before incision. And PCA with sufentanil 1ug/ml was started immediately after surgery. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status Ⅰ-Ⅱ ;
- Weight 50-75 kg;
Key exclusion criteria (6 listed)
- Long history of alcohol or analgesic drugs(including opioid ) abuse;
- Heavy smoking;
- Motion sickness;
- Long history of PONV;
- Chronic pain;
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 |
|---|---|---|
| SufentanilAlso: Sufentanil Citrate InjectionPatients received intravenous sufentanil 0.5μg/kg for induction,and received PCA after surgery with sufentanil 1ug/ml using a controlled infusion pump, which was programmed to use a loading dose of 2ml, background infusion at 2m/h, PCA dose of 1ml, lockout time of 10min, and maximal dose of 12ml within 1 hour period. | Drug | patients undergoing pancreatectomy |
| dexmedetomidineAlso: Dexmedetomidine Hydrochloride InjectionPatients received intravenous dexmedetomidine 1μg/Kg for induction. | Drug | patients undergoing pancreatectomy |
| propofolAlso: propofol injectionPatients received intravenous propofol 2mg/Kg for induction, and received intavenous pump of propofol (0.3-0.6mg/kg/h) for maintenance. | Drug | patients undergoing pancreatectomy |
| RocuroniumAlso: Rocuronium Bromide InjectionPatients received intravenous rocuronium 0.6mg/Kg for induction. | Drug | patients undergoing pancreatectomy |
| sevofluranePatients received inhalation of sevoflurane (1-2%) for maintenance. | Drug | patients undergoing pancreatectomy |
| remifentanilAlso: remifentanil Citrate InjectionPatients received intavenous pump of remifentanil (0.1-0.2ug/kg/min) for maintenance. | Drug | patients undergoing pancreatectomy |
| ParecoxibAlso: DynastatParecoxib 40mg was given single intravenously before incision. | Drug | patients undergoing pancreatectomy |
Primary outcome
Quantification of methylation in CpG islands located in gene OPRM1
Time frame: 3 months
EDTA anti-coagulated blood was collected before induction. Genomic DNA was extracted according to the manufacturer's protocol, and CpG islands in the OPRM1 gene region were identified by CpG Island Explorer 2.0 software. Quantification of DNA methylation of all CpG sites from position +528 to +1649 in CpG islands was analysed.
14 secondary outcomes
Pressure pain threshold (PPT) and pressure pain tolerance (PTO)
Time frame: 1 day
Sex
Time frame: 1 day
Age
Time frame: 1 day
Weight
Time frame: 1 day
Height
Time frame: 1 day
History of smoking
Time frame: 1 day
VAS (static) and VAS (dynamic)
Time frame: 6hours, 12hours, 24hours, 48hours after surgery.
Ramssay
Time frame: 6hours, 12hours, 24hours, 48hours after surgery.
Heart rate (HR)
Time frame: 6hours, 12hours, 24hours, 48hours after surgery
Blood pressure (BP)
Time frame: 6hours, 12hours, 24hours, 48hours after surgery.
Pulse oxygen saturation (SpO2)
Time frame: 6hours, 12hours, 24hours, 48hours after surgery.
PCA pressing frequency
Time frame: 6hours, 12hours, 24hours, 48hours after surgery
PCA consumption
Time frame: 6hours, 12hours, 24hours, 48hours after surgery
Side effects
Time frame: 6hours, 12hours, 24hours, 48hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Individual participant dataSharing planned: No
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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.
Xu Hui contact
Xu Hui study chair
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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 Sufentanil, dexmedetomidine and propofol in people with Epigenetics, run by Huazhong University of Science and Technology at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 1 May 2017. 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 China. 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 Ai Ling (+8613667135571, aileen911@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of methylation in CpG islands located in gene OPRM1 (time frame: 3 months). 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 1 May 2017.