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

Not Applicable

Completed

• Conditions: Hemodynamic Instability; Postoperative Recovery; Thoracic Surgery; Anesthesia, General; Elderly Patients
• Interventions: Drug: Esketamine; Drug: Normal Saline (0.9% Sodium Chloride); Drug: Midazolam; Drug: Sufentanil; Drug: propofol; Drug: Rocuronium

• Registration Number: NCT07064408
• Lead Sponsor: Hebei Medical University Fourth Hospital

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.

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2025-06
• Study First Submitted: 2025-06-25
• Study First Submitted QC: 2025-07-03
• Last Update Submitted: 2025-07-03
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esketamine Group	Esketamine	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.
Esketamine Group	Midazolam	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.
Esketamine Group	Sufentanil	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.
Esketamine Group	propofol	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.
Esketamine Group	Rocuronium	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.
Control Group	Normal Saline (0.9% Sodium Chloride)	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.
Control Group	Midazolam	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.
Control Group	Sufentanil	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.
Control Group	propofol	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.
Control Group	Rocuronium	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.

Primary Outcome Measures

Name	Time	Method
Maximum Decrease in Mean Arterial Pressure (MAP) During Anesthesia Induction	From 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 Outcome Measures

Name	Time	Method
Time to Eye Opening After Surgery	Postoperative 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 Induction	From 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 Delirium	From 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.
Postoperative Morphine Requirement	Within 1 hour after surgery in PACU	Number of patients requiring morphine for pain relief and total dose (mg) administered in the PACU.

Trial Locations

Locations (1)

The Fourth Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China