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

NCT ID: NCT03135795

Last Updated: 2017-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-06

Study Completion Date

2017-05-31

Brief Summary

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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

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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

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Epigenetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sufentanil

Intervention Type 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.

dexmedetomidine

Intervention Type DRUG

Patients received intravenous dexmedetomidine 1μg/Kg for induction.

propofol

Intervention Type DRUG

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

Rocuronium

Intervention Type DRUG

Patients received intravenous rocuronium 0.6mg/Kg for induction.

sevoflurane

Intervention Type DRUG

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

remifentanil

Intervention Type DRUG

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

Parecoxib

Intervention Type DRUG

Parecoxib 40mg was given single intravenously before incision.

Interventions

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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.

Intervention Type DRUG

dexmedetomidine

Patients received intravenous dexmedetomidine 1μg/Kg for induction.

Intervention Type DRUG

propofol

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

Intervention Type DRUG

Rocuronium

Patients received intravenous rocuronium 0.6mg/Kg for induction.

Intervention Type DRUG

sevoflurane

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

Intervention Type DRUG

remifentanil

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

Intervention Type DRUG

Parecoxib

Parecoxib 40mg was given single intravenously before incision.

Intervention Type DRUG

Other Intervention Names

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Sufentanil Citrate Injection Dexmedetomidine Hydrochloride Injection propofol injection Rocuronium Bromide Injection remifentanil Citrate Injection Dynastat

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Ai Ling

attending doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xu Hui

Role: STUDY_CHAIR

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

Locations

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

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ai Ling

Role: CONTACT

+8613667135571

Xu Hui

Role: CONTACT

+8613971001596

Facility Contacts

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Ai Ling

Role: primary

+8613667135571

Xu Hui

Role: backup

+8613971001596

Other Identifiers

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ALing

Identifier Type: -

Identifier Source: org_study_id

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