Tokyo, Sept. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062953) titled 'A study comparing estimated fentanyl concentrations during patient-controlled pain relief after laparoscopic or robot-assisted stomach and colorectal surgery' on Sept. 16.
Study Type:
Observational
Primary Sponsor:
Institute - Tokushima University
Condition:
Condition - Postoperative pain following laparoscopic or robot-assisted gastric or colorectal resection
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To retrospectively characterize modeled fentanyl effect-site concentration trajectories during the first 48 hours after the end of anesthesia in adults receiving postoperative fentanyl intravenous patient-controlled analgesia (IV-PCA), and to compare interval-specific minimum modeled effect-site concentrations (Ce_min) between minimally invasive gastric resection and minimally invasive colorectal resection. Both groups include conventional laparoscopic and robot-assisted laparoscopic procedures.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - Patients meeting all of the following criteria:
1. Underwent elective laparoscopic or robot-assisted gastric or colorectal resection under general anesthesia at Tokushima University Hospital between October 2021 and February 2024.
2. Were aged 20 years or older and younger than 70 years at the time of surgery.
3. Received postoperative intravenous patient-controlled analgesia (IV-PCA) with fentanyl.
Key exclusion criteria - Patients meeting any of the following criteria:
1. Conversion to open surgery.
2. Unavailable or incomplete IV-PCA administration records that preclude reconstruction of the dosing history required to estimate fentanyl effect-site concentrations.
3. Refusal to allow the use of their clinical information for this study.
Target Size - 90
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2024 Year 03 Month 15 Day
Date of IRB - 2024 Year 05 Month 27 Day
Anticipated trial start date - 2024 Year 03 Month 16 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072041
Disclaimer: Curated by HT Syndication.