Subanesthetic Esketamine for Hemodynamic Stability and Recovery in Elderly Thoracic Surgery Patients

NCT ID: NCT07064408

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-11-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Esketamine Group

Participants in this group received a subanesthetic dose of esketamine (0.25 mg/kg) intravenously during induction of general anesthesia. The esketamine was administered slowly over approximately 30 seconds after midazolam and sufentanil, and prior to propofol and rocuronium. Standard anesthesia induction and maintenance protocols were followed thereafter.

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: DRUG

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.

Midazolam

Intervention Type: DRUG

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

Sufentanil

Intervention Type: DRUG

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

propofol

Intervention Type: DRUG

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

Rocuronium

Intervention Type: DRUG

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

Control Group

Participants in this group received an equivalent volume of 0.9% normal saline intravenously during induction of general anesthesia, administered in the same manner and time frame as in the esketamine group. The saline was administered after midazolam and sufentanil, and prior to propofol and rocuronium. All other aspects of anesthesia management were identical to the esketamine group.

Group Type: PLACEBO_COMPARATOR

Normal Saline (0.9% Sodium Chloride)

Intervention Type: DRUG

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.

Midazolam

Intervention Type: DRUG

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

Sufentanil

Intervention Type: DRUG

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

propofol

Intervention Type: DRUG

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

Rocuronium

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Midazolam

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

Intervention Type: DRUG

Sufentanil

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

Intervention Type: DRUG

propofol

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

Intervention Type: DRUG

Rocuronium

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

2023026

Identifier Type: -

Identifier Source: org_study_id