Hemodynamic InstabilityNCT07064408
Subanesthetic Esketamine for Hemodynamic Stability and Recovery in Elderly Thoracic Surgery Patients
A study testing Esketamine, Normal Saline (0.9% Sodium Chloride) and Midazolam in people with Hemodynamic Instability and Postoperative Recovery, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Hemodynamic Instability, Postoperative Recovery, Thoracic Surgery
- What is being tested?
- Esketamine, Normal Saline (0.9% Sodium Chloride) and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Elevated intracranial or intraocular pressure
- Use of monoamine oxidase inhibitors within 24 hours before surgery
- History of substance abuse
Trial locations and contacts
1 site in 1 country.
China1 site
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
About this study
Official title: 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
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.
Read the 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
- Keywords
- Esketamine, Hemodynamic stability, Anesthesia induction, Recovery quality, Elderly patients, Thoracic surgery, Postoperative outcomes, Randomized controlled trial, Perioperative management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
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.
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.
MidazolamDrug
Intravenous administration of 2 mg midazolam during anesthesia induction for sedation. Administered prior to study drug.
SufentanilDrug
Intravenous administration of 50 µg sufentanil for analgesia during anesthesia induction. Administered prior to study drug.
propofolDrug
Intravenous administration of 2 mg/kg propofol for loss of consciousness during anesthesia induction. Administered after study drug.
RocuroniumDrug
Intravenous administration of 0.6 mg/kg rocuronium to facilitate neuromuscular blockade and endotracheal intubation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Normal Saline (0.9% Sodium Chloride); Drug: Midazolam; Drug: Sufentanil; Drug: propofol; Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From anesthesia induction to skin incision (approximately 15 minutes)
Secondary outcomes (4)
Time to Eye Opening After Surgery
The duration between the end of surgery and the patient's spontaneous eye opening, measured in minutes in the PACU.
Measured: Postoperative period in PACU (within 30 minutes after surgery)
Incidence of Hypotension During Anesthesia Induction
Defined as mean arterial pressure (MAP) < 65 mmHg or the need for vasopressor intervention (norepinephrine) between induction and intubation.
Measured: From anesthesia induction to intubation (approximately 5 minutes)
Incidence of Postoperative Delirium
Evaluated using the Confusion Assessment Method for the ICU (CAM-ICU) during the recovery period.
Measured: From PACU admission to hospital discharge (up to 24 hours postoperatively)
Postoperative Morphine Requirement
Number of patients requiring morphine for pain relief and total dose (mg) administered in the PACU.
Measured: Within 1 hour after surgery in PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Jun 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064408
- Sponsor's protocol ID
- 2023026
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to ethical and privacy considerations and the absence of participant consent for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07064408
- Acronym / sponsor ID
- 2023026
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esketamine Group | Experimental | Drug: Esketamine, Drug: Midazolam, Drug: Sufentanil, Drug: propofol, Drug: RocuroniumParticipants 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 | Placebo comparator | Drug: Normal Saline (0.9% Sodium Chloride), Drug: Midazolam, Drug: Sufentanil, Drug: propofol, Drug: RocuroniumParticipants 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. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsketamineIntravenous 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. | Drug | Esketamine Group |
| 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. | Drug | Control Group |
| MidazolamIntravenous administration of 2 mg midazolam during anesthesia induction for sedation. Administered prior to study drug. | Drug | Control Group, Esketamine Group |
| SufentanilIntravenous administration of 50 µg sufentanil for analgesia during anesthesia induction. Administered prior to study drug. | Drug | Control Group, Esketamine Group |
| propofolIntravenous administration of 2 mg/kg propofol for loss of consciousness during anesthesia induction. Administered after study drug. | Drug | Control Group, Esketamine Group |
| RocuroniumIntravenous administration of 0.6 mg/kg rocuronium to facilitate neuromuscular blockade and endotracheal intubation. | Drug | Control Group, Esketamine Group |
Primary outcome
Maximum Decrease in Mean Arterial Pressure (MAP) During Anesthesia Induction
Time frame: 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.
4 secondary outcomes
Time to Eye Opening After Surgery
Time frame: Postoperative period in PACU (within 30 minutes after surgery)
Incidence of Hypotension During Anesthesia Induction
Time frame: From anesthesia induction to intubation (approximately 5 minutes)
Incidence of Postoperative Delirium
Time frame: From PACU admission to hospital discharge (up to 24 hours postoperatively)
Postoperative Morphine Requirement
Time frame: Within 1 hour after surgery in PACU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No. IPD will not be shared due to ethical and privacy considerations and the absence of participant consent for data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine, Normal Saline (0.9% Sodium Chloride) and Midazolam in people with Hemodynamic Instability and Postoperative Recovery, run by Hebei Medical University Fourth Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Decrease in Mean Arterial Pressure (MAP) During Anesthesia Induction (time frame: From anesthesia induction to skin incision (approximately 15 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.