Tokyo, Feb. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060630) titled 'The effect of anesthetics on postoperative delirium in hip fracture surgery in elderly patients
-comparison of remimazolam and desflurane-' on Feb. 10.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Active
Primary Sponsor:
Institute - Japan Community Healthcare Organization Tokuyama Central Hospital
Condition:
Condition - hip fractures
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine whether the use of remimazolam is associated with an increased or decreased incidence of postoperative delirium compared with desflurane in elderly patients undergoing surgery for hip fractures.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - remimazolam
Interventions/Control_2 - desflurane
Eligibility:
Age-lower limit - 65
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - the following criteria are in order to meet eligibility requirements for the current study.
1)Patients undergoing surgery for hip fracture during the research period
2)Patients over 65 years or older
Key exclusion criteria - Patients who meet any of the following conditions will not be included in this study:
1)Patients with a history of hypersensitivity to remimazolam or desflurane
2)Patients with acute obstructive glaucoma
3)Patients with myasthenia gravis
4)Patients in shock, coma, or acute alcohol poisoning
5)Patients with a history of malignant hyperthermia or a history of malignant hyperthermia in a blood relative
6)Patients who are unable to communicate due to severe mental illness, language impairment, visual impairment, etc.
7)Patients who developed new cerebrovascular disease during the period
8)Patients requiring intensive care management
9)Patients who died within 5 days after surgery
Target Size - 600
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2023 Year 08 Month 16 Day
Date of IRB - 2026 Year 02 Month 04 Day
Anticipated trial start date - 2026 Year 02 Month 10 Day
Last follow-up date - 2030 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069347
Disclaimer: Curated by HT Syndication.