NCT05474937 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Agostoni M, Fanti L, Gemma M, Pasculli N, Beretta L, Testoni PA
Adverse events during monitored anesthesia care for GI endoscopy: an 8-year experience. Gastrointest Endosc. 2011 Aug;74(2):266-75. doi: 10.1016/j.gie.2011.04.028. Epub 2011 Jun 25.
Agrawal D, Feldman HA, Krauss B, Waltzman ML
Bispectral index monitoring quantifies depth of sedation during emergency department procedural sedation and analgesia in children. Ann Emerg Med. 2004 Feb;43(2):247-55.
Basturk A, Artan R, Yilmaz A
Efficacy and safety of midazolam and ketamine in paediatric upper endoscopy. Arab J Gastroenterol. 2017 Jun;18(2):80-82. doi: 10.1016/j.ajg.2017.05.004. Epub 2017 Jun 1.
Biliškov AN, Ivancev B, Pogorelic Z
Effects on Recovery of Pediatric Patients Undergoing Total Intravenous Anesthesia with Propofol versus Ketofol for Short-Lasting Laparoscopic Procedures. Children (Basel). 2021 Jul 19;8(7). pii: 610. doi: 10.3390/children8070610.
Gaya da Costa M, Kalmar AF, Struys MMRF
Inhaled Anesthetics: Environmental Role, Occupational Risk, and Clinical Use. J Clin Med. 2021 Mar 22;10(6). pii: 1306. doi: 10.3390/jcm10061306. Review.
Oh C, Kim Y, Eom H, Youn S, Lee S, Ko YB, Yoo HJ, Chung W, Lim C, Hong B
Procedural Sedation Using a Propofol-Ketamine Combination (Ketofol) vs. Propofol Alone in the Loop Electrosurgical Excision Procedure (LEEP): A Randomized Controlled Trial. J Clin Med. 2019 Jun 28;8(7). pii: E943. doi: 10.3390/jcm8070943.

Nasal Inhalation of Sevoflurane Versus Midazolm,Ketamine and Propofol For Pediatric Undergoing Upper Gastrointestinal Endoscopy

Clinical trial NCT05474937 - References