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

Epigenetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03135795
• Other study ID #: ALing
• Status: Recruiting
• Phase: Phase 4
• First received: March 1, 2017
• Last updated: April 26, 2017
• Start date: February 6, 2017
• Est. completion date: May 31, 2017

Study information

• Verified date: April 2017
• Source: Huazhong University of Science and Technology
• Contact: Ai Ling
• Phone: +8613667135571
• Email: aileen911[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore the epigenetic mechanism of postoperative analgesia and side effect induced by μ-opioid Receptor Agonists presented with sufentanil among general population.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status ?-? ;

• 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.

Related Conditions & MeSH terms

• Epigenetics

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pressure pain threshold (PPT) and pressure pain tolerance (PTO)	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).	1 day
Secondary	Sex	Patients' sex (male or female) was recorded before surgery.	1 day
Secondary	Age	Patients' age in years was recorded before surgery.	1 day
Secondary	Weight	Patients' weight in kilograms was recorded before surgery.	1 day
Secondary	Height	Patients' height in meters was recorded before surgery.	1 day
Secondary	History of smoking	Patients' history of smoking (yes or no) was recorded before surgery.	1 day
Secondary	VAS (static) and VAS (dynamic)	Patients' VAS(static) and VAS(dynamic) score (range 0-10) were recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.	6hours, 12hours, 24hours, 48hours after surgery.
Secondary	Ramssay	Patients' Ramssay score (range 1-6) was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.	6hours, 12hours, 24hours, 48hours after surgery.
Secondary	Heart rate (HR)	Patients' HR in bpm was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.	6hours, 12hours, 24hours, 48hours after surgery
Secondary	Blood pressure (BP)	Patients' BP in mmHg was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.	6hours, 12hours, 24hours, 48hours after surgery.
Secondary	Pulse oxygen saturation (SpO2)	Patients' SpO2 in percent was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.	6hours, 12hours, 24hours, 48hours after surgery.
Secondary	PCA pressing frequency	Patients' PCA pressing frequency in time was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.	6hours, 12hours, 24hours, 48hours after surgery
Secondary	PCA consumption	Patients' PCA consumption in ml was recorded at time point of 6hours, 12hours, 24hours, 48hours after surgery.	6hours, 12hours, 24hours, 48hours after surgery
Secondary	Side effects	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.	6hours, 12hours, 24hours, 48hours after surgery