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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07064408
Enrollment
230
Registered
2025-07-14
Start date
2023-06-01
Completion date
2024-11-30
Last updated
2025-07-14

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

Conditions

Hemodynamic Instability, Postoperative Recovery, Thoracic Surgery, Anesthesia, General, Elderly Patients

Keywords

Esketamine, Hemodynamic stability, Anesthesia induction, Recovery quality, Elderly patients, Thoracic surgery, Postoperative outcomes, Randomized controlled trial, Perioperative management

Brief 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.

Interventions

DRUGEsketamine

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.

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.

DRUGMidazolam

Intravenous administration of 2 mg midazolam during anesthesia induction for sedation. Administered prior to study drug.

DRUGSufentanil

Intravenous administration of 50 µg sufentanil for analgesia during anesthesia induction. Administered prior to study drug.

DRUGpropofol

Intravenous administration of 2 mg/kg propofol for loss of consciousness during anesthesia induction. Administered after study drug.

DRUGRocuronium

Intravenous administration of 0.6 mg/kg rocuronium to facilitate neuromuscular blockade and endotracheal intubation.

Sponsors

Hebei Medical University Fourth Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Age 65-75 years * Scheduled for elective thoracic surgery (e.g., lobectomy, bullectomy) * ASA physical status I-III * Adequate cardiopulmonary function * Able to provide informed consent * Preoperative systolic blood pressure \<160 mmHg with stable control * No cognitive impairment

Exclusion criteria

* Severe cardiovascular disease (e.g., unstable angina, heart failure ≥ NYHA class III) * History of cerebrovascular disease * Uncontrolled hypertension (SBP \>180 mmHg) * Severe hepatic or renal dysfunction * Chronic psychiatric illness or long-term CNS-active drug use * Allergy to ketamine or its derivatives * Elevated intracranial or intraocular pressure * Use of monoamine oxidase inhibitors within 24 hours before surgery * History of substance abuse

Design outcomes

Primary

MeasureTime frameDescription
Maximum Decrease in Mean Arterial Pressure (MAP) During Anesthesia InductionFrom anesthesia induction to skin incision (approximately 15 minutes)The lowest value of MAP recorded between the time of anesthesia induction and skin incision, compared to baseline MAP before induction. This outcome evaluates the degree of hemodynamic depression associated with induction agents and the protective effect of esketamine.

Secondary

MeasureTime frameDescription
Postoperative Morphine RequirementWithin 1 hour after surgery in PACUNumber of patients requiring morphine for pain relief and total dose (mg) administered in the PACU.
Time to Eye Opening After SurgeryPostoperative period in PACU (within 30 minutes after surgery)The duration between the end of surgery and the patient's spontaneous eye opening, measured in minutes in the PACU.
Incidence of Hypotension During Anesthesia InductionFrom anesthesia induction to intubation (approximately 5 minutes)Defined as mean arterial pressure (MAP) \< 65 mmHg or the need for vasopressor intervention (norepinephrine) between induction and intubation.
Incidence of Postoperative DeliriumFrom PACU admission to hospital discharge (up to 24 hours postoperatively)Evaluated using the Confusion Assessment Method for the ICU (CAM-ICU) during the recovery period.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026