Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059116) titled 'A Study on the Interaction Between Anesthetic and Analgesic Drugs' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Dose comparison
Primary Sponsor:
Institute - Kansai Medical University
Condition:
Condition - Patients who undergo surgery under general anesthesia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Previous studies have shown that remifentanil affects three effect-site concentrations of propofol, the concentration at loss of responsiveness , the concentration at which the power in the alpha frequency band is maximal, and the concentration at which burst suppression patterns appear on the EEG - during the initiation of total intravenous anesthesia with propofol. In this study, we will investigate whether increasing the concentration of remifentanil further influences these three propofol concentrations.
Basic objectives2 - PK,PD
Intervention:
Interventions/Control_1 - Remifentanil 0 ng/mL group
Interventions/Control_2 - Remifentanil 3.0 ng/mL group
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - The study will include patients undergoing surgery under general anesthesia at Kansai Medical University Hospital. To select surgeries with stable hemodynamics, patients scheduled for breast surgery or laparoscopic cholecystectomy will be included.
Key exclusion criteria - Exclusion criteria included serious liver dysfunction, renal dysfunction, or psychological disorders, pregnancy, lactation or receipt of psychotropic drugs, and allergy to propofol or remifentanil.
Target Size - 90
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 01 Day
Anticipated trial start date - 2025 Year 10 Month 01 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067625
Disclaimer: Curated by HT Syndication.
