Can olanzapine help prevent confusion after cancer surgery in elderly patients

Perioperative Oral Olanzapine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Abdominopelvic Oncological Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/07/113415

Enrollment

148

Registered

2026-07-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F59- Unspecified behavioral syndromes associated with physiological disturbances and physical factors

Interventions

Intervention1: Perioperative oral olanzapine: for prevention of postoperative delirium in elderly patients undergoing abdominopelvic oncological surgery Control Intervention1: placebo mouth dispersibl

Eligibility

Inclusion criteria

Inclusion criteria: elective abdominopelvic oncological surgery more than or equal to 2 hours ASA 1 to 3 HMSE more than and equal to 24 at preoperative baseline written informed consent

Exclusion criteria

Exclusion criteria: Pre-existing dementia or HMSE less than 24 Parkinson disease or other dopaminergic neurodegenerative disorder History of Postoperative Delirium or current alcohol dependence or active psychotic disorder or current antipsychotic use QTc more than 450 ms for males or more than 470 ms female Moderate to severe hepatic impairment Child Pugh Class B or C or baseline albumin less than or equal to 3.5 QTc prolonging agents or strong CYP1A2 interactors that cannot be withheld Known hypersensitivity to olanzapine Emergency surgery or neuraxial anaesthesia as sole technique Other interventional trial within 30 days.

Design outcomes

Primary

Measure	Time frame
Delirium assessed twice daily on post operative delirium 1 to 5 using confusion assesment method intensive care unit until extubation and Confusion assessment method score after extubation Timepoint: Delirium assessed twice daily on post operative delirium 1 to 5 using confusion assesment method intensive care unit until extubation and Confusion assessment method score after extubation at 10 am and 10 pm	—

Measure

Time frame

Delirium assessed twice daily on post operative delirium 1 to 5 using confusion assesment method intensive care unit until extubation and Confusion assessment method score after extubation Timepoint: Delirium assessed twice daily on post operative delirium 1 to 5 using confusion assesment method intensive care unit until extubation and Confusion assessment method score after extubation at 10 am and 10 pm

—

Secondary

Measure	Time frame
Assessment of post operative delirium severity memorial delirium score 0 to 30 administered when CAM ICU or CAM score is positive and duration and time to onset and postoperative pain and Postoperative Nausea Vomiting assessment and anaesthetic requirements and ICU and hospital length of stay and Safety outcomes like excessive sedation and extra pyramidal symptoms which is clinically assessed and QTc prolongation on serial ECG and haemodynamic instability with mean arterial pressure less than 65 mmHg or more than 20 percent drop from baseline and Exploratory perioperative biomarker trajectories including IL6 and S100beta and exploratory Larsen paradox assessment descriptive comparison of memorial delirium assessment peak score and delirium duration in breakthrough post operative delirium cases across armsTimepoint: Delirium severity assessed twice daily on post operative delirium 1 to 5 if CAM OR CAM ICU at 10 am and 10 pm	—

Measure

Time frame

Assessment of post operative delirium severity memorial delirium score 0 to 30 administered when CAM ICU or CAM score is positive and duration and time to onset and postoperative pain and Postoperative Nausea Vomiting assessment and anaesthetic requirements and ICU and hospital length of stay and Safety outcomes like excessive sedation and extra pyramidal symptoms which is clinically assessed and QTc prolongation on serial ECG and haemodynamic instability with mean arterial pressure less than 65 mmHg or more than 20 percent drop from baseline and Exploratory perioperative biomarker trajectories including IL6 and S100beta and exploratory Larsen paradox assessment descriptive comparison of memorial delirium assessment peak score and delirium duration in breakthrough post operative delirium cases across armsTimepoint: Delirium severity assessed twice daily on post operative delirium 1 to 5 if CAM OR CAM ICU at 10 am and 10 pm

—

Countries

India

Contacts

Public ContactAISHWARYA VENUGOPALAN

AIIMS DELHI

ash.vk28@gmail.com8129573470

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026