Clinical Trials Directory

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

TypeNameDescription
DRUGEsketamineIntravenous 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.
DRUGNormal 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.
DRUGMidazolamIntravenous administration of 2 mg midazolam during anesthesia induction for sedation. Administered prior to study drug.
DRUGSufentanilIntravenous administration of 50 µg sufentanil for analgesia during anesthesia induction. Administered prior to study drug.
DRUGpropofolIntravenous administration of 2 mg/kg propofol for loss of consciousness during anesthesia induction. Administered after study drug.
DRUGRocuroniumIntravenous 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.