Assessing the feasibility of non-steroidal anti-inflammatory drugs, benzodiazapines or no intervention in patients older than 60 who are having major surgery

NSAID administration Or Theatre Benzodiazepines Avoidance for Delirium and Days alive and at home out of hospital: Pilot, double-blind, open label, three-arm RCT Pilot Trial (NOTBADD)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12625001042437

Acronym

NOTBADD

Enrollment

Registered

2025-09-22

Start date

2025-10-20

Completion date

Unknown

Last updated

2025-09-29

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

Conditions

None listed

Brief summary

This pilot project aims to assess if conducting a study comparing administration of non-steroidal anti-inflammatory drugs, benzodiazapines and no intervention is feasible. The study is being undertaken in patients older than 60 who are having major surgery (not involving the heart or the brain). Study participants will be randomly allocated to one of three treatment groups, non-steroidal anti inflammatory, benzodiazepine or no intervention. Participants will also be asked to undergo delirium assessments for the first 3 post-operative days. If this pilot study is able to be completed with minimal deviations to the protocol and a good participant recruitment rate, a larger study will be undertaken. The larger study will assess the rate and severity of post-operative delirium - a type of temporary confusion and/or agitation that occurs after surgery and is more common in older adults.

Interventions

Intervention arm 1: Celecoxib 200mg oral tablet, twice daily for 3 days, total of 6 doses. Two doses administered on the day of surgery and post-operative days 1 and 2. Electronic medication charts will be monitored to review adherence to this intervention. Intervention arm 2: Midazolam intravenous injection 0.03mg/kg prior to the induction of anaesthesia. The administration will occur immediately prior to Anaesthesia induction. Anaesthetics charts will be reviewed to monitor adherence to this

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients aged 60 years and over 2) Able to provide informed consent, 3) English speaking (for cognitive testing), 4) undergoing major non-cardiac, non-intracranial surgery (defined as a minimum anticipated stay of >2 days).

Exclusion criteria

1) Preexisting delirium 2) Dementia (pre-existing clinical diagnosis) 3) known allergy or contraindication to celecoxib or midazolam 4) administration of an NSAID or benzodiazepine within 12 hours 5) renal disease with creatinine clearance <30ml/min 6) liver cirrhosis, 7) weight less than 50 kilograms 8) ASA classification greater than 3 9) life expectancy of less than 30 days regardless of surgery

Outcome results