NCT03716453 - 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)

Boselli E, Bouvet L, Bégou G, Dabouz R, Davidson J, Deloste JY, Rahali N, Zadam A, Allaouchiche B
Prediction of immediate postoperative pain using the analgesia/nociception index: a prospective observational study. Br J Anaesth. 2014 Apr;112(4):715-21. d
Daccache G, Jeanne M, Fletcher D
The Analgesia Nociception Index: Tailoring Opioid Administration. Anesth Analg. 2017 Jul;125(1):15-17. doi: 10.1213/ANE.0000000000002145.
Dundar N, Kus A, Gurkan Y, Toker K, Solak M
Analgesia nociception index (ani) monitoring in patients with thoracic paravertebral block: a randomized controlled study. J Clin Monit Comput. 2018 Jun;32(3):481-486. doi: 10.1007/s10877-017-0036-9. Epub 2017

A Comparative Study of Intraoperative Fentanyl Consumption Guided by Analgesia Nociception Index Versus Standard Protocol in Patients Undergoing Mastectomy

Details for clinical trial NCT03716453

Clinical trial NCT03716453 - References