Combination of olanzapine with bispectral index guided anesthesia to prevent postoperative delirium in elderly patients undergoing major gastrointestinal elective surgery: a randomized, double-blind, placebo-controlled study protocol

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Raquel Costa
https://orcid.org/0000-0002-6175-8056
Osama Zied Alzobi
https://orcid.org/0000-0002-0327-7967
Salim Al-Busaidi
Diego Arbaje
https://orcid.org/0000-0002-4988-2310
Catherine Avery Skinner
Victor Batistella
https://orcid.org/0000-0001-8535-135X
Eleonora Boschetti Grutzmacher
Gabriela Casais
https://orcid.org/0000-0001-7584-1830
Denisse Castro
https://orcid.org/0000-0001-5330-9309
Moyses Cohen
Annette García Delgado
https://orcid.org/0000-0002-2604-7275
Muhammad Haseeb
Veronica Hernandez Leon
https://orcid.org/0000-0003-2910-4965
Pedro Hilton de Andrade Filho
https://orcid.org/0000-0002-0572-971X
Brahim Khouri Lopez
Aline Marcadenti
https://orcid.org/0000-0003-1994-4610
Jannis Müller
Diego Noya Rabelo
https://orcid.org/0000-0001-6483-4491
Flavia Tarcha
Juliana Tepedino Martins Alves
Francisca Urrutia Goldsack
https://orcid.org/0000-0002-9850-181X
Eman Youssif
https://orcid.org/0000-0002-6926-1562
Arturo Tamayo
Denise Schwartz
https://orcid.org/0000-0002-7805-0716
Diego Daniel Garcia Choza
Maria Belen Cubria
Ibnouf Sulieman

Abstract

Introduction: Postoperative delirium (POD) is an important complication of major surgery in elderly patients. It increases morbidity and mortality, hospital stay, and total healthcare costs. Since no treatment has proven effective once POD is established, prevention is key. Evidence exists that bispectral index guided anesthesia (BIS-GA) and antipsychotics may independently reduce incidence of POD, but the efficacy of combining these preventive strategies is unknown. Objective: To compare the combination of olanzapine + BIS-GA with BIS-GA alone for prevention of POD in elderly patients undergoing major elective surgery.
Methods: We propose a Phase II, multi-center, randomized, double-blind, parallel, placebo-controlled trial. The study arms will be BIS-GA + two doses of olanzapine 5mg given pre and postoperatively compared with BIS-GA + placebo in patients ≥65 years hospitalized for major elective surgery. Exclusion criteria include cardiac- and neurosurgery, dementia history, concurrent antipsychotic, anticholinergic, or sedative-hypnotic use, olanzapine allergy, delirium at hospital admission, cognitive impairment and inability to be interviewed. The primary outcome is incidence of POD diagnosed by DSM-V criteria and assessed by the Confusion Assessment Method (CAM) scale. Secondary outcomes include delirium severity, rescue therapy use, length of hospital stay and incidence of adverse events.
Discussion: There is an increasing need for trials that advance knowledge in prophylactic methods to prevent delirium. By combining two preventive methods, we expect to decrease the incidence of POD, which will result in decreased morbidity, mortality, and total healthcare costs.

Article Details

How to Cite
Costa, R., Zied Alzobi, O., Al-Busaidi, S., Arbaje, D., Avery Skinner, C., Batistella, V., Boschetti Grutzmacher, E., Casais, G., Castro, D., Cohen, M., García Delgado, A., Haseeb, M., Hernandez Leon, V., Hilton de Andrade Filho, P., Khouri Lopez, B., Marcadenti, A., Müller, J., Noya Rabelo, D., Tarcha, F., Tepedino Martins Alves, J., Urrutia Goldsack, F., Youssif, E., Tamayo, A., Schwartz, D., Garcia Choza, D. D., Cubria, M. B., & Sulieman, I. (2021). Combination of olanzapine with bispectral index guided anesthesia to prevent postoperative delirium in elderly patients undergoing major gastrointestinal elective surgery: a randomized, double-blind, placebo-controlled study protocol. Principles and Practice of Clinical Research, 7(3), 35–42. https://doi.org/10.21801/ppcrj.2021.73.5
Section
Clinical Research Design

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