Tokyo, July 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062191) titled 'Clinical Utility of Capnography during Implant Surgery under Intravenous Sedation' on July 9.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Tokyo Dental College
Condition:
Condition - Patients receiving intravenous sedation during implant-related surgery
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to clarify the usefulness of capnometers in implant-related surgeries under intravenous sedation.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Connect a capnometer and observe respiration in real time.
Interventions/Control_2 - If apnea is detected by the capnometer, respiratory intervention will be performed.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Eligible patients meet the criteria of the American Society of Anesthesiologists(ASA) physical status of I-II.
Key exclusion criteria - Eligible patients meet the criteria of the American Society of Anesthesiologists(ASA) physical status of 3-5.
Patients without consent.
Patients whose SpO2 is 95% or less during daily activities.
Patients with a BMI of 30 kg/m2 or higher.
Target Size - 50
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 06 Month 30 Day
Date of IRB - 2026 Year 06 Month 30 Day
Anticipated trial start date - 2026 Year 07 Month 09 Day
Last follow-up date - 2027 Year 03 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071119
Disclaimer: Curated by HT Syndication.