Comparison of Esketamine-Propofol and Fentanyl-Propofol

Eye & ENT Hospital of Fudan University

Status: Enrolling

Conditions: Hemodynamics

Treatments: Drug: Propofol; Drug: The high dose of esketamine; Drug: The median dose of esketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT05752409

esketamine-Propofol

Details and patient eligibility

About

Propofol is widely used as an induction agent during general anesthesia. The prevalent induction dose may be associated with unacceptable cardiovascular instability, especially in elderly patients.The combination of ketamine and propofol has been shown to balance the cardiodepressant effects. Esketamine is dextrorotatory structure of ketamine but with stronger analgesic effects and fewer adverse events.However, there have been no previous published reports on the use of esketamine combined with propofol during induction. The main aim of this study was to investigate the haemodynamic effects of esketamine with propofol for the elderly during induction with LMA( laryngeal mask airway) insertion.

Full description

Propofol is widely used as an induction agent during general anesthesia. The prevalent induction dose may be associated with unacceptable cardiovascular instability, especially in elderly patients. 1.7(0.6) mg.kg-1 adjusted dosed propofol demonstrated by a large multicenter cohort is suitable to advanced patients over aged 65.

Ketamine increases heart rate and arterial blood pressure by its activation of the sympathetic nervous system. When it is used with propofol for induction of general anesthesia, the cardiostimulating effects of ketamine balance the cardiodepressant effects of propofol. Esketamine is dextrorotatory structure of ketamine but with stronger analgesic effects and fewer adverse events. A previous study has shown that the use of ketamine before induction with propofol preserves haemodynamic stability during LMA insertion. However, there have been no previous published reports on the use of esketamine combined with propofol in elderly patients for induction.

The main aim of this study was to investigate the haemodynamic effects of esketamine with propofol during induction with LMA insertion. The secondary aim was to investigate whether the administration of esketamine in induction would delay the emergence of anesthesia.

Enrollment: 120 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 》60 years
• American Society of Anesthesiologists (ASA) class I or II

Exclusion criteria

• contraindications to esketamine, such as glaucoma and large vascular aneurysms
• poorly controlled or untreated hypertension (systolic/diastolic blood pressure over 180/100 mmHg at rest)
• severe cardiopulmonary
• mental illness.
• LMA insertion failed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups

Propofol + esketamin 0.5

Experimental group

Description:

1mg•kg-1propofol, 0.5 mg•kg-1esketamin, 1 μg•kg-1 fentanyl and 0.15 mg•kg-1 cis-atracurium was administered intravenously in one minute.

Treatment:

Drug: The median dose of esketamine

Propofol+ esketamin 0.75

Experimental group

Description:

1mg•kg-1propofol, 0.75 mg•kg-1esketamin, 1 μg•kg-1 fentanyl and 0.15 mg•kg-1 cis-atracurium was administered intravenously in one minute.

Treatment:

Drug: The high dose of esketamine

Propofol

Active Comparator group

Description:

2 mg•kg-1propofol, 1 μg•kg-1 fentanyl and 0.15 mg•kg-1 cis-atracurium was administered intravenously in one minute.

Treatment:

Drug: Propofol