Clinical trial NCT05752409: Comparison of Esketamine-Propofol and Fentanyl-Propofol
Official title: Comparison of Esketamine-Propofol and Fentanyl-Propofol on Haemodynamics in Elderly Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodynamics
Keywords: esketamine
propofol
hemodynamic effects
elderly patients
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: systolic blood pressure (T0)
timeFrame: before induction of anesthesia (T0; baseline)
measure: systolic blood pressure (T1)
timeFrame: at the end of anaesthesia induction (T1)
measure: systolic blood pressure (T2)
timeFrame: at the time before LMA insertion (T2)
measure: systolic blood pressure (T3)
timeFrame: at the end of LMA insertion (T3)
measure: systolic blood pressure (T4)
timeFrame: 5min after LMA insertion (T4)
measure: systolic blood pressure (T5)
timeFrame: 10min after LMA insertion (T5)
measure: diastolic blood pressure (T0)
timeFrame: before induction of anesthesia (T0; baseline)
measure: diastolic blood pressure (T1)
timeFrame: at the end of anaesthesia induction (T1)
measure: diastolic blood pressure (T2)
timeFrame: at the time before LMA insertion (T2)
measure: diastolic blood pressure (T3)
timeFrame: at the end of LMA insertion (T3)
measure: diastolic blood pressure (T4)
timeFrame: 5min after LMA insertion (T4)
measure: diastolic blood pressure (T5)
timeFrame: 10min after LMA insertion (T5)
measure: mean arterial pressure (T0)
timeFrame: before induction of anesthesia (T0; baseline)
measure: mean arterial pressure (T1)
timeFrame: at the end of anaesthesia induction (T1)
measure: mean arterial pressure (T2)
timeFrame: at the time before LMA insertion (T2)
measure: mean arterial pressure (T3)
timeFrame: at the end of LMA insertion (T3)
measure: mean arterial pressure (T4)
timeFrame: 5min after LMA insertion(T4)
measure: mean arterial pressure (T5)
timeFrame: 10min after LMA insertion(T5)
measure: heart rate (T0)
timeFrame: before induction of anesthesia (T0; baseline)
measure: heart rate (T1)
timeFrame: at the end of anesthesia induction (T1)
measure: heart rate (T2)
timeFrame: at the time before LMA insertion (T2)
measure: heart rate (T3)
timeFrame: at the end of LMA insertion (T3)
measure: heart rate (T4)
timeFrame: 5min after LMA insertion(T4)
measure: heart rate (T5)
timeFrame: 10min after LMA insertion(T5)
measure: the occurrence of hypotension
timeFrame: during general anesthesia, about 15 min.
Secondary outcomes:
measure: Recovery time
timeFrame: from the time of completion of the procedure to the time of returning to the guard
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
name: Fang Tan
role: PRINCIPAL_INVESTIGATOR
References:
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