Effects of Esketamine and Bilateral Lower Limb Elevation on Hemodynamic Stability During Induction of General Anesthesia in Elderly Patients Undergoing Thoracic Surgery

NCT07374458 | Not Yet Recruiting DMC

• 1 other identifier: KY20251118-09
• Study Type: interventional
• Target: 292
• Locations: 0 countries
• Sites: N/A

Brief Summary

Video-assisted thoracoscopic surgery (VATS) is widely used in thoracic surgery due to small incisions, low stress response, and high patient tolerance. Compared with open thoracotomy, VATS has fewer complications, shorter hospital stays, and better postoperative quality of life. Despite being minimally invasive, VATS can cause severe postoperative pain via pleural/lung parenchyma damage, intercostal nerve traction, and chest tube stimulation. This pain impairs patient mobility (e.g., turning over, getting out of bed), increasing risks of atelectasis and pulmonary infections. Approximately 78% of patients experience moderate-to-severe postoperative pain, and 50% receive inadequate analgesia \[3\]. Effective postoperative pain management is critical for recovery and reducing pulmonary infections. In recent years, combined general anesthesia with regional nerve blocks has been recommended to enhance postoperative comfort and accelerate recovery, as regional blocks alleviate pain and reduce general anesthetic dosage. Thoracic paravertebral block (TPVB), an effective regional anesthesia technique, is commonly used for postoperative analgesia in VATS. TPVB involves injecting local anesthetics near thoracic spinal nerves exiting the intervertebral foramen, blocking ipsilateral somatic and sympathetic nerves. It is mainly used for analgesia after rib fractures, breast surgery, and thoracic surgeries (open or VATS). However, preoperative TPVB blocks both thoracic nerves and sympathetic nerves. Sympathetic inhibition reduces myocardial contractility, heart rate, and peripheral vascular resistance. Additionally, rapid administration of multiple drugs during general anesthesia induction further increases hypotension risk. Esketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has stronger sedative/analgesic effects and fewer adverse events than ketamine. Studies show sub-anesthetic doses (0.15-0.3 mg/kg) reduce induction hypotension, opioid-induced cough, and other adverse events via sympathetic stimulation, analgesia, and NMDA receptor antagonism. The passive leg raising (PLR) test assesses fluid responsiveness in acute circulatory failure by shifting \~300 mL of venous blood from lower limbs to the right heart. Its hemodynamic effects are reversible, avoiding fluid overload. Based on this, lower limb elevation during anesthesia induction rapidly and transiently increases venous return, reducing hypotension. Bilateral elevation enhances venous return, increases cardiac preload, improves cardiac output, and stabilizes blood pressure. General anesthesia induction is a period of frequent hemodynamic fluctuations. Elderly patients, often with comorbidities and reduced physiological reserve, are more susceptible to induction-related hemodynamic disturbances (40% incidence). Sustained/severe hypotension causes inadequate organ perfusion/ischemia, increasing postoperative complications (myocardial injury, ischemic stroke, acute kidney injury). Preventing post-induction hypotension in the elderly is clinically valuable. Opioids, propofol, and muscle relaxants induce hypotension via arterial dilation and reduced peripheral resistance. TPVB-induced sympathetic block further increases hypotension risk. This study hypothesizes that esketamine administration or lower limb elevation during induction reduces hypotension incidence in elderly VATS patients with TPVB.

Conditions

Post Induction Hypotension

Outcome Measures

Primary Outcomes (1)

• The incidence of hypotension

  From the start of anesthesia induction to 5 minutes after induction

Secondary Outcomes (14)

• Incidence of Severe Hypotension

  From the start of anesthesia induction to 5 minutes after induction

• Postoperative Esketamine-Related Adverse Effects

  Within 24 hours after surgery

• Postoperative Sleep Quality

  Within 24 hours after surgery

• Use of Vasoactive Medications During Anesthesia Induction

  From the start of anesthesia induction to 5 minutes after induction

• Stroke Volume During Anesthesia Induction

  From the start of anesthesia induction to 5 minutes after induction

Study Arms (4)

Esketamine + Leg Elevation;Esketamine + Supine;Placebo + Leg Elevation;Placebo + Supine (Control)

EXPERIMENTAL

Esketamine + Bilateral Lower Limb Elevation:Participants received intravenous esketamine at a dose of 0.2 mg/kg, administered one minute before anesthesia induction. Bilateral Lower Limb Elevation Participants underwent bilateral lower limb elevation to 45°, initiated one minute before anesthesia induction. Esketamine + Supine Position:Participants received intravenous esketamine at a dose of 0.2 mg/kg, administered one minute before anesthesia induction. Placebo + Bilateral Lower Limb Elevation:Participants underwent bilateral lower limb elevation to 45°, initiated one minute before anesthesia induction. No Intervention: Placebo + Supine Position

Drug: Esketamine; Behavioral: Bilateral Lower Limb Elevation

Esketamine + Supine Position

EXPERIMENTAL

Drug: Esketamine

Placebo + Bilateral Lower Limb Elevation

EXPERIMENTAL

Behavioral: Bilateral Lower Limb Elevation

Placebo + Supine Position

NO INTERVENTION

Interventions

Esketamine DRUG

Participants received intravenous esketamine at a dose of 0.2 mg/kg, administered one minute before anesthesia induction.

Esketamine + Leg Elevation;Esketamine + Supine;Placebo + Leg Elevation;Placebo + Supine (Control); Esketamine + Supine Position

Bilateral Lower Limb Elevation BEHAVIORAL

Participants underwent bilateral lower limb elevation to 45°, initiated one minute before anesthesia induction.

Esketamine + Leg Elevation;Esketamine + Supine;Placebo + Leg Elevation;Placebo + Supine (Control); Placebo + Bilateral Lower Limb Elevation

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 60-80 years old
• American Society of Anesthesiologists (ASA) physical status classification Ⅰ-Ⅲ
• Scheduled for elective thoracoscopic surgery under general anesthesia
• Informed consent: All patients or their family members voluntarily agree to participate in the study and sign the informed consent form

You may not qualify if:

• Allergy to the drugs used in this study
• Severe cardio-cerebro-pulmonary diseases (including myocardial infarction, heart failure, cerebral hemorrhage, stroke, respiratory failure)
• Severe hepatic or renal diseases (Child-Pugh class C, or requiring renal replacement therapy)
• Severe neurological diseases (including Parkinson's disease, Alzheimer's disease)
• History of poorly controlled hypertension, or systolic blood pressure \> 180 mmHg or mean arterial pressure (MAP) \< 70 mmHg before anesthesia induction
• Increased intracranial pressure, glaucoma, penetrating ocular trauma, or moderate to severe pulmonary arterial hypertension
• Spinal diseases (deformity or trauma), history of spinal surgery, abnormal skin sensation of the chest and back, infection at the puncture site, or abnormal coagulation function
• Abdominal hypertension or lower extremity deep vein thrombosis
• Emergency surgery
• Body mass index (BMI) ≥ 35 kg/m²

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

MeSH Terms

Interventions

Esketamine

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: January 28, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE