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Effects of esketamine on postoperative cognitive function and sleep in critically ill patients undergoing gastrointestinal surgery: a prospective, randomized controlled study

Effects of esketamine on postoperative cognitive function and sleep in critically ill patients undergoing gastrointestinal surgery: a prospective, randomized controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075153
Enrollment
Unknown
Registered
2023-08-28
Start date
2023-08-17
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

postoperative cognitive function and sleep

Interventions

Esketamine group: the analgesic pump adopts sufentanil 5µg/kg + esketamine 50mg + tosansetron 30mg + 0.9% sodium chloride solution with a capacity of 120ml.
Control group:The analgesic pump used sufentanil 5µg/kg + toxierise 30mg + 0.9% sodium chloride solution with a capacity of 120ml.

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria (1) Age= 45 years old (2) Undergo elective/limited gastrointestinal tumor surgery under general anesthesia, and the estimated operation time is = 2h (3) The operation can be completed before 20:00 , and the SICU will be admitted after the operation (4) The expected postoperative hospital stay= 3 days (5) Agree to use PCIA after surgery (6) Be able to understand the content of the assessment scale, and voluntarily sign the informed consent form by the patient himself or his family

Exclusion criteria

Exclusion criteria: Exclusion criteria Those who have one of the following conditions are not considered selected cases: (1) Severe central nervous system diseases (stroke, epilepsy, intracranial tumors, Parkinson's, craniocerebral trauma) (2) History of schizophrenia or a history of mental illness within 3 months or current use of antipsychotic drugs (including antidepressants and anxiolytics) (3) Inability to complete preoperative evaluation due to severe cognitive impairment (e.g., dementia, Alzheimer's) or hearing impairment (4) Have a history of drug or alcohol dependence or have taken sedative/hypnotic drugs within 1 month (5) Patients with poorly controlled or untreated hypertension (arterial hypertension, resting systolic/diastolic blood pressure exceeding 180/100mmHg) (6) Patients at serious risk of increased intracranial pressure (7) Patients with untreated or undertreated hyperthyroidism (8) Extremely critical condition, (NYHA cardiac function grade III or LVEF <30%, liver function Child-Pugh grade C, preoperative dialysis treatment, ASA grade = IV, or expected survival =24 hours) (9) Patients who are allergic to esketamine (10) Refusal to participate in this study (11) Other researchers who believe that it is not suitable to participate in this study (specific reasons need to be specified)

Design outcomes

Primary

MeasureTime frame
Changes of the N2 phase of the postoperative sleep cycle ;

Secondary

MeasureTime frame
Various sleep parameters of polysomnography, including total sleep time, sleep efficiency, sleep fragmentation index, sleep time in each period (N1, N2, N3, REM sleep) and the percentage of N1, N3, REM sleep.;Analysis results of objective sleep indicators obtained by body motion recorder;RCQS sleep score;Athens insomnia score;

Countries

China

Contacts

Public ContactHongyu Tan

Beijing Cancer Hospital

18210782671@163.com+86 186 1026 5968

Outcome results

None listed

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