The Effect of oral caffeine tablets on the incidence of postoperative delirium

The Effect of oral caffeine tablets on the incidence of postoperative delirium in elderly patients undergoing hip fracture surgery with Spinal Anesthesia. A Randomized Controlled Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202510547964657

Enrollment

Registered

2025-10-08

Start date

2023-08-01

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Fertility-female Paediatrics Anaesthesia

Interventions

adding oral caffeine

Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both sex. 2. Age above 65 years old 3. ASA of class I and II 4. Planned for elective orthopedic surgery under spinal anesthesia. 5. Anticipated hospital length of stay at least 48 hours

Exclusion criteria

Exclusion criteria: 1. Patient refusal. 2. Contraindication to neuroaxial block. 3. Uncontrolled Psychiatric diseases. 4. Known intolerance to the study drugs. 5. Unstable cardiovascular condition. 6. emergency surgery, 7. severe cognitive impairment precluding capacity for informed consent 8. acute hepatic failure (inadequate caffeine metabolism), 9. acute kidney injury preoperatively (which may impair caffeine clearance), 10. severe audiovisual impairment preventing participation in cognitive function testing.

Design outcomes

Primary

Measure	Time frame
Delirium: by Long-form Confusion Assessment Method (CAM), scored based on brief cognitive screening tests, obtained 1hour after PACU admission and twice daily for the first three postoperative days The total dose of analgesic consumed will be recorded.	—

Secondary

Measure	Time frame
Delirium severity: Measured via the same long-form CAM (CAM-S score). CAM-S is a continuous scoring metric based on the long-form CAM (scored 0–19, 19=highest severity) Delirium duration: Measured by the cumulative no of days (n) with a positive delirium screen. Quality of recovery: Patient-reported 15-item Quality of Recovery score, which will be assessed in the afternoon on postoperative day three. Sedation and agitation: will be measured by the Richmond Agitation Sedation Scale, (RASS) with a score of -2 to -5 reflecting sedation, and +2to +4 indicative of agitation. Timing of the RASS assignments will align with each CAM assessment for delirium.	—

Measure

Time frame

Delirium severity: Measured via the same long-form CAM (CAM-S score). CAM-S is a continuous scoring metric based on the long-form CAM (scored 0–19, 19=highest severity) Delirium duration: Measured by the cumulative no of days (n) with a positive delirium screen. Quality of recovery: Patient-reported 15-item Quality of Recovery score, which will be assessed in the afternoon on postoperative day three. Sedation and agitation: will be measured by the Richmond Agitation Sedation Scale, (RASS) with a score of -2 to -5 reflecting sedation, and +2to +4 indicative of agitation. Timing of the RASS assignments will align with each CAM assessment for delirium.

—

Countries

Egypt

Contacts

Public ContactGamal Yasser

Resident of Anesthesia

gemex66@gmail.com00201027768699

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026