Effects of esketamine on postoperative neurocognition and redox rhythm in patients undergoing general anesthesia: a prospective, single center, randomized, controlled, double-blind clinical trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100051179

Enrollment

Unknown

Registered

2021-09-15

Start date

2021-10-01

Completion date

Unknown

Last updated

2022-05-23

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

Conditions

Perioperative neurocognitive disorders

Interventions

Esketamine group:Esketamine treatment

Control group:Use saline

Morning operation group:Surgery between 8:00 - 12:00

Afternoon operation group:Surgery between 12:00 -18:00

Eligibility

Sex/Gender

All

Age

65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 65 to 85 years; 2. ASA classification II or III; 3. The preoperative MMSE and MoCA scores reached the normal standard; 4. The proposed anesthesia method is general anesthesia (including general anesthesia with endotracheal intubation, laryngeal mask general anesthesia, conscious sedation and analgesia), regional nerve block combined with general anesthesia; 5. The duration of anesthesia is less than 4 hours; 6. The completion of the operation meets the entry criteria for PACU; 7. Patient informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who are known to be allergic to the active ingredients or excipients of esketamine hydrochloride injection, contraindications; 2. Alcoholism, mental dependence and drug abuse; 3. Have a history of mental illness; 4. Have a history of craniocerebral trauma or craniocerebral surgery; 5. Enter the ICU to continue treatment after surgery.

Design outcomes

Primary

Measure	Time frame
The retention time in PACU;The scores of MMSE, MoCA, HDA and 3D-CAM scale;	—

Secondary

Measure	Time frame
Expression of clock proteins (Clock, Bmal1, Per, Cry), PV, Nrf2, Prdx2 and Cavlin-1 in peripheral blood mononuclear granulocyte;Contents of plasma redox markers (NADPH / NADP, SOD, MDA, PRDX);Vital signs in PACU (e.g. : SpO2, BP, heart rate, respiration, body temperature, blood gas);Interventions in PACU (e.g. : oxygen inhalation, rehydration, blood transfusion, adjustment of internal environment);Adverse events in PACU (e.g. adverse reactions, bleeding, myocardial infarction, cerebral infarction, death);Perioperative medication regimen;	—

Measure

Time frame

Expression of clock proteins (Clock, Bmal1, Per, Cry), PV, Nrf2, Prdx2 and Cavlin-1 in peripheral blood mononuclear granulocyte;Contents of plasma redox markers (NADPH / NADP, SOD, MDA, PRDX);Vital signs in PACU (e.g. : SpO2, BP, heart rate, respiration, body temperature, blood gas);Interventions in PACU (e.g. : oxygen inhalation, rehydration, blood transfusion, adjustment of internal environment);Adverse events in PACU (e.g. adverse reactions, bleeding, myocardial infarction, cerebral infarction, death);Perioperative medication regimen;

—

Countries

China

Contacts

Public ContactMeng Qingtao

Rinmin Hospital of Wuhan University

mengqingtao2018@126.com+86 13995569560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026