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Comparison of Esketamine-Propofol and Fentanyl-Propofol

Comparison of Esketamine-Propofol and Fentanyl-Propofol on Haemodynamics in Elderly Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05752409
Enrollment
120
Registered
2023-03-02
Start date
2021-10-08
Completion date
2023-12-31
Last updated
2023-08-15

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

Conditions

Hemodynamics

Keywords

esketamine, propofol, hemodynamic effects, elderly patients

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.

Interventions

DRUGThe median dose of esketamine

1mg•kg-1propofol and 0.5 mg•kg-1esketamine for general anesthesia induction.

DRUGThe high dose of esketamine

1mg•kg-1propofol and 0.75 mg•kg-1esketamine for general anesthesia induction.

DRUGPropofol

2mg•kg-1propofol for general anesthesia induction.

Sponsors

Eye & ENT Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the occurrence of hypotensionduring general anesthesia, about 15 min.hypotension is defined as systolic blood pressure decreased above 30% preanesthesia level or mean blood pressure\<65 mmHg.
systolic blood pressure (T0)before induction of anesthesia (T0; baseline)systolic blood pressure (SBP)
systolic blood pressure (T1)at the end of anaesthesia induction (T1)systolic blood pressure (SBP)
systolic blood pressure (T2)at the time before LMA insertion (T2)systolic blood pressure (SBP)
systolic blood pressure (T3)at the end of LMA insertion (T3)systolic blood pressure (SBP)
systolic blood pressure (T4)5min after LMA insertion (T4)systolic blood pressure (SBP)
systolic blood pressure (T5)10min after LMA insertion (T5)systolic blood pressure (SBP)
diastolic blood pressure (T0)before induction of anesthesia (T0; baseline)diastolic blood pressure (DBP)
diastolic blood pressure (T1)at the end of anaesthesia induction (T1)diastolic blood pressure (DBP)
diastolic blood pressure (T2)at the time before LMA insertion (T2)diastolic blood pressure (DBP)
diastolic blood pressure (T3)at the end of LMA insertion (T3)diastolic blood pressure (DBP)
diastolic blood pressure (T4)5min after LMA insertion (T4)diastolic blood pressure (DBP)
diastolic blood pressure (T5)10min after LMA insertion (T5)diastolic blood pressure (DBP)
mean arterial pressure (T0)before induction of anesthesia (T0; baseline)mean arterial pressure (MAP)
mean arterial pressure (T1)at the end of anaesthesia induction (T1)mean arterial pressure (MAP)
mean arterial pressure (T2)at the time before LMA insertion (T2)mean arterial pressure (MAP)
mean arterial pressure (T3)at the end of LMA insertion (T3)mean arterial pressure (MAP)
mean arterial pressure (T4)5min after LMA insertion(T4)mean arterial pressure (MAP)
mean arterial pressure (T5)10min after LMA insertion(T5)mean arterial pressure (MAP)
heart rate (T0)before induction of anesthesia (T0; baseline)heart rate (HR))
heart rate (T1)at the end of anesthesia induction (T1)heart rate (HR))
heart rate (T2)at the time before LMA insertion (T2)heart rate (HR))
heart rate (T3)at the end of LMA insertion (T3)heart rate (HR))
heart rate (T4)5min after LMA insertion(T4)heart rate (HR))
heart rate (T5)10min after LMA insertion(T5)heart rate (HR))

Secondary

MeasureTime frameDescription
Recovery timefrom the time of completion of the procedure to the time of returning to the guardRecovery time was the time patients are extubated and acquire 10 scores by assessed with Modified Aldrete Score.

Countries

China

Contacts

Primary ContactFang Tan, Phd
tanfang@eentanesthesia.com8613611716000
Backup ContactWenjing Yi
ywjeline@hotmail.com8613636547402

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026