Comparison of postoperative cognitive dysfunction between remimazolam and propofol anesthesia: a randomized controlled trial using the Montreal Cognitive Assessment

Comparison of postoperative cognitive dysfunction between remimazolam and propofol anesthesia: a randomized controlled trial using the Montreal Cognitive Assessment - Remimazolam-POCD RCT Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000059468

Enrollment

200

Registered

2025-10-20

Start date

2025-11-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Adult surgical patients undergoing general anesthesia (evaluation of postoperative cognitive dysfunction)

Interventions

Remimazolam group: General anesthesia will be induced and maintained with remimazolam (12.0mg/kg/hr for induction, 0.4 to 2.0 mg/kg/h for maintenance) with opioids and muscle relaxants as needed. Anes

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients aged over 65 years 2. Undergoing open abdominal surgery under general anesthesia 3. Able to complete preoperative cognitive assessment using the Montreal Cognitive Assessment (MoCA) 4. Provided written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Patients with a preoperative diagnosis of severe cognitive impairment or dementia 2. Patients with a history of psychiatric illness, epilepsy, or neurodegenerative disease3. 3. Patients with hearing or speech impairments that make MoCA assessment difficult 4. Patients undergoing neurosurgical or cardiac surgery 5. Emergency surgery cases 6. Patients who do not provide informed consent

Design outcomes

Primary

Measure	Time frame
Change in Montreal Cognitive Assessment (MoCA) total score from baseline (preoperative day) to postoperative day 7 (POD7). The POD7 assessment will be performed on postoperative day 7 without an allowable window. If the POD7 MoCA cannot be assessed, the value will be treated as missing and the reason recorded.	—

Secondary

Measure	Time frame
Key Secondary Outcome Change in MoCA total score from baseline to postoperative day 30 (POD30; allowable window POD25~40). Secondary Outcomes Incidence of clinically significant cognitive decline (over2-point decrease in MoCA from baseline to POD7 and POD30) Incidence of postoperative delirium (3D-CAM, POD0 night to POD3) Quality of recovery (QoR-15 at POD7) Intraoperative haemodynamic and anaesthetic depth parameters Postoperative complications (EPCO definitions), major adverse cardiovascular events (MACE), and readmission at 30 and 90 days	—

Measure

Time frame

Key Secondary Outcome Change in MoCA total score from baseline to postoperative day 30 (POD30; allowable window POD25~40). Secondary Outcomes Incidence of clinically significant cognitive decline (over2-point decrease in MoCA from baseline to POD7 and POD30) Incidence of postoperative delirium (3D-CAM, POD0 night to POD3) Quality of recovery (QoR-15 at POD7) Intraoperative haemodynamic and anaesthetic depth parameters Postoperative complications (EPCO definitions), major adverse cardiovascular events (MACE), and readmission at 30 and 90 days

—

Countries

Japan

Contacts

Public ContactTakuya Shiraishi

Hitachi General Hospital Anesthesiology

tshiraishi.1217@gmail.com0294-23-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026