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

NCT03135795 | Unknown Phase 4 DMC

• 1 other identifier: ALing
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Epigenetics

Keywords

sufentanil; DNA methylation

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (14)

• Pressure pain threshold (PPT) and pressure pain tolerance (PTO)

  1 day

• Sex

  1 day

• Age

  1 day

• Weight

  1 day

• Height

  1 day

Study Arms (1)

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.

Drug: Sufentanil; Drug: dexmedetomidine; Drug: propofol; Drug: Rocuronium; Drug: sevoflurane; Drug: remifentanil; Drug: Parecoxib

Interventions

Sufentanil DRUG

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.

Also known as: Sufentanil Citrate Injection

patients undergoing pancreatectomy

dexmedetomidine DRUG

Patients received intravenous dexmedetomidine 1μg/Kg for induction.

Also known as: Dexmedetomidine Hydrochloride Injection

patients undergoing pancreatectomy

propofol DRUG

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

Also known as: propofol injection

patients undergoing pancreatectomy

Rocuronium DRUG

Patients received intravenous rocuronium 0.6mg/Kg for induction.

Also known as: Rocuronium Bromide Injection

patients undergoing pancreatectomy

sevoflurane DRUG

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

patients undergoing pancreatectomy

remifentanil DRUG

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

Also known as: remifentanil Citrate Injection

patients undergoing pancreatectomy

Parecoxib DRUG

Parecoxib 40mg was given single intravenously before incision.

Also known as: Dynastat

patients undergoing pancreatectomy

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Interventions

Sufentanil; Dexmedetomidine; Propofol; Rocuronium; Sevoflurane; Remifentanil; parecoxib

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Propionates; Acids, Acyclic; Carboxylic Acids

Study Officials

• Xu Hui

  Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Ai Ling

CONTACT

+8613667135571; aileen911@126.com

Xu Hui

CONTACT

+8613971001596

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending doctor

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: May 1, 2017
• Study Start: February 6, 2017
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: May 1, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)