Trials / Completed
CompletedNCT07064408
Subanesthetic Esketamine for Hemodynamic Stability and Recovery in Elderly Thoracic Surgery Patients
Effects of Subanesthetic Dose of Esketamine on Hemodynamic Stability and Postoperative Recovery Quality in Elderly Thoracic Surgery Patients Under General Anesthesia: A Randomized Controlled Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 230 (actual)
- Sponsor
- Hebei Medical University Fourth Hospital · Academic / Other
- Sex
- All
- Age
- 65 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This retrospective study evaluated the effects of a subanesthetic dose of esketamine (0.25 mg/kg) on intraoperative hemodynamic stability and postoperative recovery quality in elderly patients (aged 65-75) undergoing thoracic surgery under general anesthesia. A total of 230 patients were included and randomly assigned to receive either esketamine or placebo during anesthesia induction. Key outcomes included blood pressure and heart rate stability, catecholamine levels, recovery time, incidence of adverse events such as delirium or nausea, and opioid use.
Detailed description
Elderly patients are at increased risk for anesthesia-related complications due to reduced physiological reserves and comorbidities. Thoracic surgery further increases this risk by inducing significant cardiovascular and sympathetic stress. Esketamine, the S-enantiomer of ketamine, possesses sympathomimetic and analgesic properties that may help stabilize circulation and reduce postoperative complications when used at subanesthetic doses. In this single-center, randomized controlled trial, patients aged 65-75 scheduled for elective thoracic surgery were administered either 0.25 mg/kg esketamine or normal saline during anesthesia induction. Hemodynamic parameters (mean arterial pressure, heart rate), plasma catecholamine concentrations (norepinephrine, epinephrine), and adverse cardiovascular responses were recorded. Postoperative outcomes included emergence time, PACU stay, incidence of delirium, hallucinations, nausea and vomiting, and opioid consumption.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Esketamine | Intravenous administration of a subanesthetic dose of esketamine (0.25 mg/kg) during induction of general anesthesia. The drug was administered slowly over approximately 30 seconds after midazolam (2 mg) and sufentanil (50 µg), and prior to propofol (2 mg/kg) and rocuronium (0.6 mg/kg). The goal was to evaluate its effect on intraoperative hemodynamic stability and postoperative recovery in elderly patients undergoing thoracic surgery. |
| DRUG | Normal Saline (0.9% Sodium Chloride) | Intravenous administration of an equivalent volume of 0.9% normal saline during anesthesia induction, matching the timing and method of the esketamine group. Used as a placebo comparator. |
| DRUG | Midazolam | Intravenous administration of 2 mg midazolam during anesthesia induction for sedation. Administered prior to study drug. |
| DRUG | Sufentanil | Intravenous administration of 50 µg sufentanil for analgesia during anesthesia induction. Administered prior to study drug. |
| DRUG | propofol | Intravenous administration of 2 mg/kg propofol for loss of consciousness during anesthesia induction. Administered after study drug. |
| DRUG | Rocuronium | Intravenous administration of 0.6 mg/kg rocuronium to facilitate neuromuscular blockade and endotracheal intubation. |
Timeline
- Start date
- 2023-06-01
- Primary completion
- 2024-11-30
- Completion
- 2024-11-30
- First posted
- 2025-07-14
- Last updated
- 2025-07-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07064408. Inclusion in this directory is not an endorsement.