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The Epigenetic Modification in OPRM1 on Postoperative Analgesia and Side Effect Induced by Sufentanil

The Influence of Epigenetic Modification in OPRM1 on Postoperative Analgesia and Side Effect Induced by μ-opioid Receptor Agonists

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03135795
Enrollment
100
Registered
2017-05-01
Start date
2017-02-06
Completion date
2017-05-31
Last updated
2017-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epigenetics

Keywords

sufentanil, DNA methylation

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.

Interventions

DRUGSufentanil

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.

DRUGdexmedetomidine

Patients received intravenous dexmedetomidine 1μg/Kg for induction.

DRUGpropofol

Patients received intravenous propofol 2mg/Kg for induction, and received intavenous pump of propofol (0.3-0.6mg/kg/h) for maintenance.

DRUGRocuronium

Patients received intravenous rocuronium 0.6mg/Kg for induction.

DRUGsevoflurane

Patients received inhalation of sevoflurane (1-2%) for maintenance.

DRUGremifentanil

Patients received intavenous pump of remifentanil (0.1-0.2ug/kg/min) for maintenance.

DRUGParecoxib

Parecoxib 40mg was given single intravenously before incision.

Sponsors

Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Quantification of methylation in CpG islands located in gene OPRM13 monthsEDTA 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.

Secondary

MeasureTime frameDescription
Sex1 dayPatients' sex (male or female) was recorded before surgery.
Age1 dayPatients' age in years was recorded before surgery.
Weight1 dayPatients' weight in kilograms was recorded before surgery.
Height1 dayPatients' height in meters was recorded before surgery.
History of smoking1 dayPatients' history of smoking (yes or no) was recorded before surgery.
VAS (static) and VAS (dynamic)6hours, 12hours, 24hours, 48hours after surgery.Patients' VAS(static) and VAS(dynamic) score (range 0-10) were recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.
Pressure pain threshold (PPT) and pressure pain tolerance (PTO)1 dayPatients' Pressure pain threshold(PPT) and pressure pain tolerance(PTO) in Kg/cm2 were measured before surgery using electronic pressure algometer (YISIDA-DS2, Hongkong, China).
Heart rate (HR)6hours, 12hours, 24hours, 48hours after surgeryPatients' HR in bpm was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.
Blood pressure (BP)6hours, 12hours, 24hours, 48hours after surgery.Patients' BP in mmHg was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.
Pulse oxygen saturation (SpO2)6hours, 12hours, 24hours, 48hours after surgery.Patients' SpO2 in percent was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.
PCA pressing frequency6hours, 12hours, 24hours, 48hours after surgeryPatients' PCA pressing frequency in time was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.
PCA consumption6hours, 12hours, 24hours, 48hours after surgeryPatients' PCA consumption in ml was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.
Side effects6hours, 12hours, 24hours, 48hours after surgerySide 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.
Ramssay6hours, 12hours, 24hours, 48hours after surgery.Patients' Ramssay score (range 1-6) was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.

Countries

China

Contacts

Primary ContactAi Ling
aileen911@126.com+8613667135571
Backup ContactXu Hui
+8613971001596

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026