Effect of esketamine on intraoperative tourniquet hypertension and postoperative recovery in orthopaedic lower extremity surgery under general anesthesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300072925

Enrollment

Unknown

Registered

2023-06-28

Start date

2023-07-01

Completion date

Unknown

Last updated

2023-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopaedic lower extremity disease

Interventions

Esketamine group:After anesthesia induction, esketamine was injected intravenously at 0.2mg /kg, diluted to 10 mL with normal saline at 1ml/s

Normal saline group:The same volume of normal saline was injected intravenously after induction of anesthesia

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective general anesthesia in orthopedic lower extremity surgery using tourniquet surgery, ASAI-II grade; 2, age 18-65 years old; 3, BMI 18-30 kg/m²; 4. Normal communication; 5. Volunteer to be tested and sign informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with adrenal cortical insufficiency 2. Patients with esketamine contraindications (such as glaucoma and large vessel aneurysms) 3. History of hypertension, peripheral vascular disease, diabetes and cerebral infarction 4. History of deep vein thrombosis; 5. Severe heart, liver or kidney disease; 6. History of chronic analgesic drug use, opioid dependence, and non-steroidal anti-inflammatory drug use; 7, mental history: such as schizophrenia, depression, dementia; 8. Unable to understand the Postoperative Recovery Quality Scale (QoR-15), Visual analogue Scale (VAS), and Anxiety Scale (SAS); 9. Patients admitted to ICU after surgery and patients who did not use tourniquet during surgery.

Design outcomes

Primary

Measure	Time frame
Incidence of intraoperative tourniquet hypertension;	—

Secondary

Measure	Time frame
Hemodynamic changes;Changes in C-reactive protein (CRP) concentration in venous blood samples;Changes in tumor necrosis factor a(TNF-a)concentration in venous blood samples;Use of vasoactive drugs;15-item Quality of Recovery,QoR-15;Pain numerical rating scale (NRS);Self-Rating Anxiety Scale(SAS);hospital stay;Psychiatric symptoms such as hallucinations and nightmares and the incidence of nausea and vomiting within 24 hours after surgery; Use of remedial painkillers and remedial antiemetics;Other complications such as dizziness, hypotension or hypertension;	—

Measure

Time frame

Hemodynamic changes;Changes in C-reactive protein (CRP) concentration in venous blood samples;Changes in tumor necrosis factor a(TNF-a)concentration in venous blood samples;Use of vasoactive drugs;15-item Quality of Recovery,QoR-15;Pain numerical rating scale (NRS);Self-Rating Anxiety Scale(SAS);hospital stay;Psychiatric symptoms such as hallucinations and nightmares and the incidence of nausea and vomiting within 24 hours after surgery; Use of remedial painkillers and remedial antiemetics;Other complications such as dizziness, hypotension or hypertension;

—

Countries

Chain

Contacts

Public ContactQiquan Zhang

Fuyang Hospital affiliated of Anhui Medical University

zhangqiquanmzk@163.com+86 173 5292 7633

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026