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Effect of subanesthetic dose esketamine on propofol-refentanil closed-loop target-controlled infusion based on NI feedback—a randomized controlled trial

Effect of subanesthetic dose esketamine on propofol-refentanil closed-loop target-controlled infusion based on NI feedback—a randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074668
Enrollment
Unknown
Registered
2023-08-11
Start date
2023-08-03
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Acute appendicitis

Interventions

Experimental group:The preset value of 36+N is the baseline value of the new EEG closed-loop feedback guidance (the N value is 8-10 from the pre-experiment)
Control group:The original default value of 36 is the baseline value of EEG closed-loop feedback guidance (obtained from the team's previous research results)

Sponsors

Department of Anesthesiology, General Hospital of the Southern Theater of the People's Liberation Army Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing laparoscopic general anesthesia surgery with anesthesia duration > 60min, 2.18~55 years old, 3.BMI=18.5kg/m2, 4. ASA Class I~II

Exclusion criteria

Exclusion criteria: Exclude patients with any of the following criteria: 1. Contraindications to esketamine, propofol or refentanil; 2. Allergic reactions to egg/soy products; Hypersensitivity to fentanyl analogues; 3. Known/suspected neurological diseases, tumors, strokes, neurodegenerative diseases, severe head injuries, seizures, previous EEG abnormalities, cognitive deficits, acquired scalp/skull abnormalities, psychiatric diseases, severe depression, post-traumatic stress disorder, psychosis; 4. Taking psychotropic drugs within the past 7 days, 5. History of substance abuse/abuse or pregnancy in the past 30 days; 6. Currently involved in any other research involving drugs or devices.

Design outcomes

Primary

MeasureTime frame
EEG value;

Secondary

MeasureTime frame
heart rate;Blood pressure;pulse;

Countries

China

Contacts

Public ContactXu Bo

Department of Anesthesiology, General Hospital of the Southern Theater of the People's Liberation Army Chinese People's Liberation Army

xubo333@hotmail.com+86 138 0273 8125

Outcome results

None listed

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