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Multifactorial Analysis of Sleep Disorders in Elderly Patients Following Prostate Surgery and the Effect of Esketamine on These Disorders

Multifactorial Analysis of Sleep Disorders in Elderly Patients Following Prostate Surgery and the Effect of Esketamine on These Disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124377
Enrollment
Unknown
Registered
2026-05-11
Start date
2024-03-20
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

Postoperative Sleep Disorders

Interventions

Esketamine Group:Following placement of the oropharyngeal airway, continuous infusion of esketamine (infusion rate: 0.3 mg/kg/h) is initiated and maintained until the conclusion of surgery.
Control group:After placement of the laryngeal mask, initiate continuous infusion of an equal volume of normal saline (infusion rate: 0.3 mg/kg/h) until the conclusion of surgery.
Parts I :None

Sponsors

The First Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Parts I (1) Elective transurethral prostate surgery under general anesthesia; (2) Age 65 to 90 years; (3) ASA physical status classification I to III; (4) Patients capable of participating in questionnaire surveys. 2.Part II (1) Elective transurethral prostate surgery under general anesthesia; (2) Age 65 to 90 years; (3) ASA physical status classification I to III; (4) Patients capable of participating in questionnaire surveys.

Exclusion criteria

Exclusion criteria: 1.Parts I (1) Patient refuses to participate in the study. (2) Preoperative Richards-Campbell Sleep Questionnaire (RCSQ) score = 50 or Athens Insomnia Scale (AIS) score > 6. (3) Use of hypnotics within the past month. (4) Recent history of substance abuse. (5) Cognitive impairment or inability to communicate. (6) Severe organ dysfunction. (7) Postoperative transfer to the ICU. 2.Part II (1) Contraindications or allergies to esketamine or other drugs used in this study. (2) Preoperative Richards-Campbell Sleep Questionnaire (RCSQ) score = 50 or Athens Insomnia Scale (AIS) score = 6. (3) Use of hypnotics/sedatives within the past month. (4) Recent history of substance abuse. (5) Cognitive impairment or communication difficulties. (6) Severe cardiopulmonary disease, severe renal impairment (requiring dialysis), or severe hepatic impairment (Child-Pugh class C). (7) Patient refuses to participate in this study. (8) Postoperative transfer to the intensive care unit.

Design outcomes

Primary

MeasureTime frame
Parts I :Incidence of Postoperative Sleep Disturbance;Parts I :Risk Factors for Sleep Disturbance;Part II:Incidence of Postoperative Sleep Disturbance;

Secondary

MeasureTime frame
Comorbidities (Hypertension, Diabetes Mellitus, Coronary Heart Disease, Cerebrovascular Disease); Laboratory indicators;Richards-Campbell Sleep Questionnaire (RCSQ) score;Athens Insomnia Scale (AIS) score;Hospital Anxiety and Depression Scale (HADS) score;Pain score;Quality of Recovery-15 (QoR-15) score;Richards-Campbell Sleep Questionnaire (RCSQ) score;Athens Insomnia Scale (AIS) score;Hospital Anxiety and Depression Scale (HADS) score;Pain score;Diastolic blood pressure;Delirium Assessment;Systolic Blood Pressure;Diastolic blood pressure;Average Pressure;Heart rate;Bispectral Index (BIS) value;Intraoperative anesthetic drug dosage;Surgery time;Duration of anesthesia;Time of extubation of laryngeal mask or endotracheal tube;Infusion volume;Intraoperative blood loss;Postoperative complication incidence rate;Serum melatonin;Brain-derived neurotrophic factor;Cortisol;Tumor Necrosis Factor-alpha;C-reactive protein;Interleukin-1ß;Interleukin-6;Interleukin-8;

Countries

China

Contacts

Public ContactYubo Xie

The First Affiliated Hospital of Guangxi Medical University

1157817791@qq.com+86 139 7712 1557

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026