The Epigenetic Modification in OPRM1 on Postoperative Analgesia and Side Effect Induced by Sufentanil
NCT ID: NCT03135795
Last Updated: 2017-05-01
Study Results
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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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2017-02-06
2017-05-31
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
SCREENING
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.
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.
dexmedetomidine
Patients received intravenous dexmedetomidine 1μg/Kg for induction.
propofol
Patients received intravenous propofol 2mg/Kg for induction, and received intavenous pump of propofol (0.3-0.6mg/kg/h) for maintenance.
Rocuronium
Patients received intravenous rocuronium 0.6mg/Kg for induction.
sevoflurane
Patients received inhalation of sevoflurane (1-2%) for maintenance.
remifentanil
Patients received intavenous pump of remifentanil (0.1-0.2ug/kg/min) for maintenance.
Parecoxib
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.
dexmedetomidine
Patients received intravenous dexmedetomidine 1μg/Kg for induction.
propofol
Patients received intravenous propofol 2mg/Kg for induction, and received intavenous pump of propofol (0.3-0.6mg/kg/h) for maintenance.
Rocuronium
Patients received intravenous rocuronium 0.6mg/Kg for induction.
sevoflurane
Patients received inhalation of sevoflurane (1-2%) for maintenance.
remifentanil
Patients received intavenous pump of remifentanil (0.1-0.2ug/kg/min) for maintenance.
Parecoxib
Parecoxib 40mg was given single intravenously before incision.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weight 50-75 kg;
Exclusion Criteria
* Heavy smoking;
* Motion sickness;
* Long history of PONV;
* Chronic pain;
* Complicated with severe heart、brain or kidney disease.
35 Years
60 Years
ALL
No
Sponsors
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Huazhong University of Science and Technology
OTHER
Responsible Party
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Ai Ling
attending doctor
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
Countries
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Central Contacts
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Xu Hui
Role: CONTACT
Facility Contacts
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Xu Hui
Role: backup
Other Identifiers
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ALing
Identifier Type: -
Identifier Source: org_study_id
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