Comparison of Esketamine-Propofol and Fentanyl-Propofol

Sponsor

Eye & ENT Hospital of Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05752409

Collaborator

(none)

120

Enrollment

Location

Arms

21.7

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodynamics	Drug: The median dose of esketamine Drug: The high dose of esketamine Drug: Propofol	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 8, 2021

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Propofol + esketamin 0.5 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.	Drug: The median dose of esketamine 1mg•kg-1propofol and 0.5 mg•kg-1esketamine for general anesthesia induction. Other Names: s(+)ketamine
Experimental: Propofol+ esketamin 0.75 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.	Drug: The high dose of esketamine 1mg•kg-1propofol and 0.75 mg•kg-1esketamine for general anesthesia induction. Other Names: s(+)ketamine
Active Comparator: Propofol 2 mg•kg-1propofol, 1 μg•kg-1 fentanyl and 0.15 mg•kg-1 cis-atracurium was administered intravenously in one minute.	Drug: Propofol 2mg•kg-1propofol for general anesthesia induction. Other Names: Propofol 10 mg/ml Injection

Arm

Intervention/Treatment

Experimental: Propofol + esketamin 0.5

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.

Drug: The median dose of esketamine

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

Other Names:

s(+)ketamine

Experimental: Propofol+ esketamin 0.75

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.

Drug: The high dose of esketamine

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

Other Names:

s(+)ketamine

Active Comparator: Propofol

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

Drug: Propofol

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

Other Names:

Propofol 10 mg/ml Injection

Outcome Measures

Primary Outcome Measures

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))
the occurrence of hypotension [during general anesthesia, about 15 min.]
hypotension is defined as systolic blood pressure decreased above 30% preanesthesia level or mean blood pressure<65 mmHg.

Secondary Outcome Measures

Recovery time [from the time of completion of the procedure to the time of returning to the guard]
Recovery time was the time patients are extubated and acquire 10 scores by assessed with Modified Aldrete Score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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.