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Effects of Continuous Infusion of Different Doses of Esketamine on Bispectral Index During Sevoflurane Anesthesia in Elderly Patients

Effects of Continuous Infusion of Different Doses of Esketamine on Bispectral Index During Sevoflurane Anesthesia in Elderly Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124820
Enrollment
Unknown
Registered
2026-05-18
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

None

Interventions

Group C:Continuous intravenous infusion of normal saline at 0.05 mL/kg/h until deep abdominal wall suture
Group E1 (Low-dose Esketamine group):Continuous intravenous infusion of Esketamine 0.125 mg/kg/h (diluted to 20 mL) at 0.05 mL/kg/h until deep abdominal wall suture
Group E2 (High-dose Esketamine group):Continuous intravenous infusion of Esketamine 0.25 mg/kg/h (diluted to 20 mL) at 0.05 mL/kg/h until deep abdominal wall suture

Sponsors

The First Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged 60 to 80 years old with no gender restriction; 2.Elderly patients undergoing elective laparoscopic renal surgery; 3.American Society of Anesthesiologists (ASA) physical status classification Grade ?-?; 4.Body Mass Index (BMI) ranging from 18 to 30 kg/m^2; 5.Normal cognitive function with a Mini-Mental State Examination (MMSE) score >= 24 points; 6.Normal communication ability and capability to cooperate with postoperative follow-up and scale evaluation; 7.Written informed consent signed by the patient or their family members.

Exclusion criteria

Exclusion criteria: 1.History of confirmed mental illness, drug or alcohol abuse; 2.Severe hepatic and renal insufficiency (liver function indicators exceeding twice the upper limit of normal, creatinine clearance rate of renal function 180/110 mmHg; 5.Combined with contraindications for esketamine use such as glaucoma and hyperthyroidism; 6.Cognitive dysfunction with MMSE score <24 points; 7.Presence of communication disorders and inability to cooperate with the completion of study-related assessments; 8.Preoperative severe cardiovascular and respiratory diseases that cannot tolerate surgery and anesthesia; 9.Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Changes in Bispectral Index (BIS) at different time points after infusion of Esketamine or normal saline;Area under the BIS curve (AUC);

Secondary

MeasureTime frame
Spectral Edge Frequency 95 (SEF95);Heart rate (HR) and mean arterial pressure (MAP);Total intraoperative remifentanil consumption;Postoperative resting and activity numerical rating scale (NRS) pain scores;

Countries

China

Contacts

Public ContactYan Wei

The First Affiliated Hospital of Harbin Medical University

31660213@qq.com+86 139 3626 1086

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026