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

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ClinicalTrials.gov Identifier: NCT03135795
Recruitment Status : Unknown
Verified April 2017 by Ai Ling, Huazhong University of Science and Technology.
Recruitment status was:  Recruiting
First Posted : May 1, 2017
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Ai Ling, Huazhong University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Epigenetics Drug: Sufentanil Drug: dexmedetomidine Drug: propofol Drug: Rocuronium Drug: sevoflurane Drug: remifentanil Drug: Parecoxib Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Influence of Epigenetic Modification in OPRM1 on Postoperative Analgesia and Side Effect Induced by μ-opioid Receptor Agonists
Actual Study Start Date : February 6, 2017
Estimated Primary Completion Date : May 31, 2017
Estimated Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: patients undergoing pancreatectomy
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
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.
Other Name: Sufentanil Citrate Injection

Drug: dexmedetomidine
Patients received intravenous dexmedetomidine 1μg/Kg for induction.
Other Name: Dexmedetomidine Hydrochloride Injection

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

Drug: Rocuronium
Patients received intravenous rocuronium 0.6mg/Kg for induction.
Other Name: Rocuronium Bromide Injection

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

Drug: remifentanil
Patients received intavenous pump of remifentanil (0.1-0.2ug/kg/min) for maintenance.
Other Name: remifentanil Citrate Injection

Drug: Parecoxib
Parecoxib 40mg was given single intravenously before incision.
Other Name: Dynastat




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pressure pain threshold (PPT) and pressure pain tolerance (PTO) [ Time Frame: 1 day ]
    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).

  2. Sex [ Time Frame: 1 day ]
    Patients' sex (male or female) was recorded before surgery.

  3. Age [ Time Frame: 1 day ]
    Patients' age in years was recorded before surgery.

  4. Weight [ Time Frame: 1 day ]
    Patients' weight in kilograms was recorded before surgery.

  5. Height [ Time Frame: 1 day ]
    Patients' height in meters was recorded before surgery.

  6. History of smoking [ Time Frame: 1 day ]
    Patients' history of smoking (yes or no) was recorded before surgery.

  7. VAS (static) and VAS (dynamic) [ Time Frame: 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.

  8. Ramssay [ Time Frame: 6hours, 12hours, 24hours, 48hours after surgery. ]
    Patients' Ramssay score (range 1-6) was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.

  9. Heart rate (HR) [ Time Frame: 6hours, 12hours, 24hours, 48hours after surgery ]
    Patients' HR in bpm was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.

  10. Blood pressure (BP) [ Time Frame: 6hours, 12hours, 24hours, 48hours after surgery. ]
    Patients' BP in mmHg was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.

  11. Pulse oxygen saturation (SpO2) [ Time Frame: 6hours, 12hours, 24hours, 48hours after surgery. ]
    Patients' SpO2 in percent was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.

  12. PCA pressing frequency [ Time Frame: 6hours, 12hours, 24hours, 48hours after surgery ]
    Patients' PCA pressing frequency in time was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.

  13. PCA consumption [ Time Frame: 6hours, 12hours, 24hours, 48hours after surgery ]
    Patients' PCA consumption in ml was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.

  14. Side effects [ Time Frame: 6hours, 12hours, 24hours, 48hours after surgery ]
    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.



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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135795


Contacts
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Contact: Ai Ling +8613667135571 aileen911@126.com
Contact: Xu Hui +8613971001596

Locations
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China, Hubei
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Ai Ling    +8613667135571    aileen911@126.com   
Contact: Xu Hui    +8613971001596      
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
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Study Chair: Xu Hui Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

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Responsible Party: Ai Ling, attending doctor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03135795     History of Changes
Other Study ID Numbers: ALing
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ai Ling, Huazhong University of Science and Technology:
sufentanil
DNA methylation

Additional relevant MeSH terms:
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Anticoagulants
Propofol
Dexmedetomidine
Sufentanil
Sevoflurane
Remifentanil
Parecoxib
Rocuronium
Citric Acid
Sodium Citrate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Analgesics, Opioid