Clinical trial NCT03135795: The Epigenetic Modification in OPRM1 on Postoperative Analgesia and Side Effect Induced by Sufentanil
Official title: The Influence of Epigenetic Modification in OPRM1 on Postoperative Analgesia and Side Effect Induced by μ-opioid Receptor Agonists
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Epigenetics
Keywords: sufentanil
DNA methylation
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status Ⅰ-Ⅱ ;
* Weight 50-75 kg;

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Quantification of methylation in CpG islands located in gene OPRM1
timeFrame: 3 months
Secondary outcomes:
measure: Pressure pain threshold (PPT) and pressure pain tolerance (PTO)
timeFrame: 1 day
measure: Sex
timeFrame: 1 day
measure: Age
timeFrame: 1 day
measure: Weight
timeFrame: 1 day
measure: Height
timeFrame: 1 day
measure: History of smoking
timeFrame: 1 day
measure: VAS (static) and VAS (dynamic)
timeFrame: 6hours, 12hours, 24hours, 48hours after surgery.
measure: Ramssay
timeFrame: 6hours, 12hours, 24hours, 48hours after surgery.
measure: Heart rate (HR)
timeFrame: 6hours, 12hours, 24hours, 48hours after surgery
measure: Blood pressure (BP)
timeFrame: 6hours, 12hours, 24hours, 48hours after surgery.
measure: Pulse oxygen saturation (SpO2)
timeFrame: 6hours, 12hours, 24hours, 48hours after surgery.
measure: PCA pressing frequency
timeFrame: 6hours, 12hours, 24hours, 48hours after surgery
measure: PCA consumption
timeFrame: 6hours, 12hours, 24hours, 48hours after surgery
measure: Side effects
timeFrame: 6hours, 12hours, 24hours, 48hours after surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Xu Hui
role: STUDY_CHAIR
References: