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The Effect of Subanesthetic Dose Esketamine on Postoperative Awakening in Elderly Patients Under Inhaled General Anesthesia for Non-cardiac Surgery: A Randomized, Double-blind, Blank Controlled Clinical Study

The Effect of Subanesthetic Dose Esketamine on Postoperative Awakening in Elderly Patients Under Inhaled General Anesthesia for Non-cardiac Surgery: A Randomized, Double-blind, Blank Controlled Clinical Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109724
Enrollment
Unknown
Registered
2025-09-24
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

General Surgery,Gynecological and extracrinal system diseases

Interventions

BC group:Saline was given 30 minutes before the end of surgery
EA group:0.125 mg/kg esketamine was given before the end of surgery
EB group:0.25 mg/kg esketamine was given before the end of surgery

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age > 65 and < 90 years; 2. ASA I-III level; 3. Abdominal, gynecological, or urological surgery performed under general anesthesia via laparoscopy or open surgery; 4. Expected anesthesia time exceeding 60 min, and post-operative transfer to PACU; 5. Willing to comply with this experimental process and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Unable to obtain informed consent; 2. Anesthesia time exceeds 4 hours or postoperative transfer to ICU; 3. Known allergy or intolerance to anesthetic drugs or other adverse conditions; 4. Presence of acute or chronic pain preoperatively, peripheral or central nervous system disorders; 5. History of chronic opioid or non-opioid analgesic use; 6. Clearly diagnosed psychiatric history or other neurological or psychiatric conditions affecting judgment with severe cognitive impairment, history of using psychoactive substances; 7. Severe auditory, visual, and speech impairments, inability to speak English or Chinese, communication difficulties; 8. Baseline average arterial pressure (MAP) less than 60 mmHg or greater than 120 mmHg, baseline heart rate less than 45 bpm or greater than 100 bpm, presence of second-degree or higher conduction block; 9. History of severe underlying diseases (untreated or persistent peripheral or central cardiovascular diseases, severe liver and kidney diseases, severe pulmonary diseases).

Design outcomes

Primary

MeasureTime frame
Awakening time;Incidence of postoperative delirium;Altered sleep rhythms;

Secondary

MeasureTime frame
Extubation time;BIS;qCON;qNOX;Use of postoperative analgesic medications;Anxiety level;

Countries

China

Contacts

Public ContactZhao Yuelei

Tianjin Medical University General Hospital

1849934037@qq.com+86 188 3239 3250

Outcome results

None listed

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