Comparison of Esketamine-Propofol and Fentanyl-Propofol

August 12, 2023 updated by: Eye & ENT Hospital of Fudan University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Recruiting
        • Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery time
Time Frame: 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.
from the time of completion of the procedure to the time of returning to the guard

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Investigators

  • Principal Investigator: Fang Tan, Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2021

Primary Completion (Estimated)

November 30, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

January 28, 2023

First Submitted That Met QC Criteria

February 21, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • esketamine-Propofol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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