Comparison of Esketamine-Propofol and Fentanyl-Propofol
- Conditions
- Hemodynamics
- Interventions
- Registration Number
- NCT05752409
- Lead Sponsor
- Eye & ENT Hospital of Fudan University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- age 》60 years
- American Society of Anesthesiologists (ASA) class I or II
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propofol + esketamin 0.5 The median dose of esketamine 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. Propofol+ esketamin 0.75 The high dose of esketamine 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. Propofol Propofol 2 mg•kg-1propofol, 1 μg•kg-1 fentanyl and 0.15 mg•kg-1 cis-atracurium was administered intravenously in one minute.
- Primary Outcome Measures
Name Time Method diastolic blood pressure (T4) 5min after LMA insertion (T4) diastolic blood pressure (DBP)
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 (T4) 5min after LMA insertion(T4) heart rate (HR))
heart rate (T5) 10min after LMA insertion(T5) heart rate (HR))
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 (T5) 10min after LMA insertion (T5) systolic blood pressure (SBP)
diastolic blood pressure (T3) at the end of LMA insertion (T3) diastolic blood pressure (DBP)
systolic blood pressure (T4) 5min after LMA insertion (T4) systolic blood pressure (SBP)
diastolic blood pressure (T2) at the time before LMA insertion (T2) diastolic blood pressure (DBP)
mean arterial pressure (T0) before induction of anesthesia (T0; baseline) 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)
heart rate (T2) at the time before LMA insertion (T2) heart rate (HR))
diastolic blood pressure (T1) at the end of anaesthesia induction (T1) diastolic blood pressure (DBP)
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)
diastolic blood pressure (T0) before induction of anesthesia (T0; baseline) diastolic blood pressure (DBP)
mean arterial pressure (T1) at the end of anaesthesia induction (T1) mean arterial pressure (MAP)
diastolic blood pressure (T5) 10min after LMA insertion (T5) diastolic blood pressure (DBP)
mean arterial pressure (T2) at the time before LMA insertion (T2) mean arterial pressure (MAP)
heart rate (T1) at the end of anesthesia induction (T1) heart rate (HR))
heart rate (T3) at the end of LMA insertion (T3) 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
Name Time Method 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.
Trial Locations
- Locations (1)
Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China