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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03916120
Other study ID # 2018-067
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2018
Est. completion date January 15, 2019

Study information

Verified date April 2019
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Postoperative pain remains relatively high within 48h for Chinese patients who receive video-assisted thoracoscopic surgery. Different patients experience different pain intensity. This suggests that there may be genetic variants that make some patients susceptible to analgesic failure. Using blood samples from patients, the investigators are going to analyze the relationship between single nucleotide polymorphisms (SNPs) in genes that are known to be involved in analgesic failure.


Recruitment information / eligibility

Status Completed
Enrollment 198
Est. completion date January 15, 2019
Est. primary completion date January 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Age = 70 and Age =18

- Selective operation lung section with video-assisted thoracic surgery (VATS)

- III = American Society of Anesthesiologists classification (ASA classification) =I

- Patients informed and agreed to join the study

Exclusion Criteria:

- Abnormal function of liver and kidney

- Allergic- dependence history of alcohol, opioids and Local anesthetics

- No noncompliance

- Mental disease history,language communication disorder,cicatricial diathesis

- Underweight or overweight(BMI<18 or >30)

- Patients not suitable for clinical subjects for other reasons

- Sedatives, analgesics, antiemetic drugs and anti pruritus drugs were used within 24hours before the operation.

- History of previous abnormal anaesthesia

- Women during pregnancy or lactation

Study Design


Intervention

Genetic:
Genetic analysis
Collect 2ml intravenous blood from patients after anaesthesia.

Locations

Country Name City State
China The second affiliated hospital of Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative analgesic failure Once patient experience at least one of the following situations:
Bad patients sleep quality
Require extra analgesic drug
Low satisfaction with pain control
Bolus times > 1 per hour
8 a.m. at the first day after surgery.
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