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

NCT07064408 | Completed

• 1 other identifier: 2023026
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Maximum Decrease in Mean Arterial Pressure (MAP) During Anesthesia Induction

  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.

  From anesthesia induction to skin incision (approximately 15 minutes)

Secondary Outcomes (4)

• Time to Eye Opening After Surgery

  Postoperative period in PACU (within 30 minutes after surgery)

• Incidence of Hypotension During Anesthesia Induction

  From anesthesia induction to intubation (approximately 5 minutes)

• Incidence of Postoperative Delirium

  From PACU admission to hospital discharge (up to 24 hours postoperatively)

• Postoperative Morphine Requirement

  Within 1 hour after surgery in PACU

Study Arms (2)

Esketamine Group

EXPERIMENTAL

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.

Drug: Esketamine; Drug: Midazolam; Drug: Sufentanil; Drug: propofol; Drug: Rocuronium

Control Group

PLACEBO COMPARATOR

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.

Drug: Normal Saline (0.9% Sodium Chloride); Drug: Midazolam; Drug: Sufentanil; Drug: propofol; Drug: Rocuronium

Interventions

Esketamine 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.

Esketamine Group

Normal Saline (0.9% Sodium Chloride) 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.

Control Group

Midazolam DRUG

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

Control Group; Esketamine Group

Sufentanil DRUG

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

Control Group; Esketamine Group

propofol DRUG

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

Control Group; Esketamine Group

Rocuronium DRUG

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

Control Group; Esketamine Group

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location

MeSH Terms

Interventions

Esketamine; Saline Solution; Sodium Chloride; Midazolam; Sufentanil; Propofol; Rocuronium

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 14, 2025
• Study Start: June 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)