NCT03869346|UnknownDMC
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Sponsor study identifier
observational
200
1 country
1
Study Start
March 10, 2019
Actual (reported)Primary Completion
March 10, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 20, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Purpose: This study aimed to investigate the impact of CYP3A4\*1G genetic polymorphism on non-analgesic effects of fentanyl in Chinese Han patients. Methods: 200 patients receiving elective surgery under general anesthesia were recruited into this study. Venous blood was withdrawn for genotyping of CYP3A4\*1G before operation. Fentanyl 2 µg/kg was administered preoperatively. Bispectral Index (BIS), Respiratory rate(RR), etc at Tb (entering room), T0 (drug administration), T1 (2min), T2 (4min), T3(6min), T4(8min), T5(10min), T6(20min) were recorded.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 20, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2019
Actual (reported)March 10, 2019
Actual (reported)March 11, 2019
Actual (reported)March 10, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 20, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
bispectral index
bispectral index(BIS): assessing the sedation, placed on the patient's forehead, BIS values 0-100, and the higher score means patients are more conscious
20 min after administration
respiratory rate
Number of breaths per minute
20 min after administration
CYP3A4*1G Polymorphism
The patients were classified by genotype including wild-type homozygote (CYP3A4\*1/\*1, GG), mutant heterozygote (CYP3A4\*1/\*1G, GA), and mutant homozygote (CYP3A4\*1G/\*1G, AA).
1 week after operation
wild-type homozygote (CYP3A4\*1/\*1, GG)
mutant heterozygote (CYP3A4\*1/\*1G, GA),
mutant homozygote (CYP3A4\*1G/\*1G, AA)
200 Chinese Han patients receiving elective surgery under general anesthesia
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
200 blood samples were withdrawn
Yi Feng, Professor
Peking University People's Hospital
First Submitted
March 1, 2019
First Posted
March 11, 2019
Study Start
March 10, 2019
Actual (reported)Primary Completion
March 10, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
May 20, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 6, 2019
Record last verified: 2019-09
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Source: ClinicalTrials.gov.
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