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Status unknownNCT05752409Updated Aug 15, 2023

Comparison of Esketamine-Propofol and Fentanyl-Propofol

An interventional study of The median dose of esketamine and The high dose of esketamine in Hemodynamics, sponsored by Eye & ENT Hospital of Fudan University. Status unknown at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-08-15.

Sponsored by Eye & ENT Hospital of Fudan University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Oct 2021, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hemodynamics

Keywords

  • esketamine
  • propofol
  • hemodynamic effects
  • elderly patients
03

In context

Lead sponsor

Eye & ENT Hospital of Fudan University is the lead sponsor of 124 studies on the registry; 68 are open to participants now.

Browse Eye & ENT Hospital of Fudan University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age 》60 years
  • American Society of Anesthesiologists (ASA) class I or II

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugThe median dose of esketamine

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

    Also known as: s(+)ketamine

  • DrugThe high dose of esketamine

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

    Also known as: s(+)ketamine

  • DrugPropofol

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

    Also known as: Propofol 10 mg/ml Injection

06

What researchers measure

Primary outcomes

  1. systolic blood pressure (T0)

    systolic blood pressure (SBP)

    Time frame: before induction of anesthesia (T0; baseline)

  2. systolic blood pressure (T1)

    systolic blood pressure (SBP)

    Time frame: at the end of anaesthesia induction (T1)

  3. systolic blood pressure (T2)

    systolic blood pressure (SBP)

    Time frame: at the time before LMA insertion (T2)

  4. systolic blood pressure (T3)

    systolic blood pressure (SBP)

    Time frame: at the end of LMA insertion (T3)

  5. systolic blood pressure (T4)

    systolic blood pressure (SBP)

    Time frame: 5min after LMA insertion (T4)

  6. systolic blood pressure (T5)

    systolic blood pressure (SBP)

    Time frame: 10min after LMA insertion (T5)

  7. diastolic blood pressure (T0)

    diastolic blood pressure (DBP)

    Time frame: before induction of anesthesia (T0; baseline)

  8. diastolic blood pressure (T1)

    diastolic blood pressure (DBP)

    Time frame: at the end of anaesthesia induction (T1)

  9. diastolic blood pressure (T2)

    diastolic blood pressure (DBP)

    Time frame: at the time before LMA insertion (T2)

  10. diastolic blood pressure (T3)

    diastolic blood pressure (DBP)

    Time frame: at the end of LMA insertion (T3)

  11. diastolic blood pressure (T4)

    diastolic blood pressure (DBP)

    Time frame: 5min after LMA insertion (T4)

  12. diastolic blood pressure (T5)

    diastolic blood pressure (DBP)

    Time frame: 10min after LMA insertion (T5)

  13. mean arterial pressure (T0)

    mean arterial pressure (MAP)

    Time frame: before induction of anesthesia (T0; baseline)

  14. mean arterial pressure (T1)

    mean arterial pressure (MAP)

    Time frame: at the end of anaesthesia induction (T1)

  15. mean arterial pressure (T2)

    mean arterial pressure (MAP)

    Time frame: at the time before LMA insertion (T2)

  16. mean arterial pressure (T3)

    mean arterial pressure (MAP)

    Time frame: at the end of LMA insertion (T3)

  17. mean arterial pressure (T4)

    mean arterial pressure (MAP)

    Time frame: 5min after LMA insertion(T4)

  18. mean arterial pressure (T5)

    mean arterial pressure (MAP)

    Time frame: 10min after LMA insertion(T5)

  19. heart rate (T0)

    heart rate (HR))

    Time frame: before induction of anesthesia (T0; baseline)

  20. heart rate (T1)

    heart rate (HR))

    Time frame: at the end of anesthesia induction (T1)

  21. heart rate (T2)

    heart rate (HR))

    Time frame: at the time before LMA insertion (T2)

  22. heart rate (T3)

    heart rate (HR))

    Time frame: at the end of LMA insertion (T3)

  23. heart rate (T4)

    heart rate (HR))

    Time frame: 5min after LMA insertion(T4)

  24. heart rate (T5)

    heart rate (HR))

    Time frame: 10min after LMA insertion(T5)

  25. the occurrence of hypotension

    hypotension is defined as systolic blood pressure decreased above 30% preanesthesia level or mean blood pressure\<65 mmHg.

    Time frame: during general anesthesia, about 15 min.

Secondary outcomes

  1. Recovery time

    Recovery time was the time patients are extubated and acquire 10 scores by assessed with Modified Aldrete Score.

    Time frame: from the time of completion of the procedure to the time of returning to the guard

07

Study locations

1 of 1 sites recruiting
  • Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
    Shanghai, Shanghai Municipality 200031, China
    Recruiting
08

References and documents

Publications

  • Li J, Wang Z, Wang A, Wang Z. Clinical effects of low-dose esketamine for anaesthesia induction in the elderly: A randomized controlled trial. J Clin Pharm Ther. 2022 Jun;47(6):759-766. doi: 10.1111/jcpt.13604. Epub 2022 Jan 11. PubMed 35018643 ↗
  • Yang H, Zhao Q, Chen HY, Liu W, Ding T, Yang B, Song JC. The median effective concentration of propofol with different doses of esketamine during gastrointestinal endoscopy in elderly patients: A randomized controlled trial. Br J Clin Pharmacol. 2022 Mar;88(3):1279-1287. doi: 10.1111/bcp.15072. Epub 2021 Oct 8. PubMed 34496448 ↗
  • Tu W, Yuan H, Zhang S, Lu F, Yin L, Chen C, Li J. Influence of anesthetic induction of propofol combined with esketamine on perioperative stress and inflammatory responses and postoperative cognition of elderly surgical patients. Am J Transl Res. 2021 Mar 15;13(3):1701-1709. eCollection 2021. PubMed 33841692 ↗
  • Zheng Y, Xu Y, Huang B, Mai Y, Zhang Y, Zhang Z. Effective dose of propofol combined with a low-dose esketamine for gastroscopy in elderly patients: A dose finding study using dixon's up-and-down method. Front Pharmacol. 2022 Sep 20;13:956392. doi: 10.3389/fphar.2022.956392. eCollection 2022. PubMed 36204220 ↗
  • Wei W, Zhang A, Liu L, Zheng X, Tang C, Zhou M, Gu Y, Yao Y. Effects of subanaesthetic S-ketamine on postoperative delirium and cognitive function in elderly patients undergoing non-cardiac thoracic surgery: a protocol for a randomised, double-blinded, placebo-controlled and positive-controlled, non-inferiority trial (SKED trial). BMJ Open. 2022 Aug 1;12(8):e061535. doi: 10.1136/bmjopen-2022-061535. PubMed 35914911 ↗
  • Brinck ECV, Maisniemi K, Kankare J, Tielinen L, Tarkkila P, Kontinen VK. Analgesic Effect of Intraoperative Intravenous S-Ketamine in Opioid-Naive Patients After Major Lumbar Fusion Surgery Is Temporary and Not Dose-Dependent: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Anesth Analg. 2021 Jan;132(1):69-79. doi: 10.1213/ANE.0000000000004729. PubMed 32167978 ↗
  • Xu Y, Zheng Y, Tang T, Chen L, Zhang Y, Zhang Z. The effectiveness of esketamine and propofol versus dezocine and propofol sedation during gastroscopy: A randomized controlled study. J Clin Pharm Ther. 2022 Sep;47(9):1402-1408. doi: 10.1111/jcpt.13678. Epub 2022 Apr 30. PubMed 35488787 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2021 (actual). Primary completion is estimated for Nov 2023, 25 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 28, 2023
First posted
Mar 2, 2023
StartActual
Oct 8, 2021
Primary completionEst.
Nov 30, 2023
CompletionEst.
Dec 31, 2023
Last update
Aug 15, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05752409
Lead sponsor
Eye & ENT Hospital of Fudan University
Responsible party
Sponsor
First posted
Mar 2, 2023
Start date
Oct 8, 2021
Primary completion
Nov 30, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Aug 15, 2023

Study contacts

Fang Tan, Phd
Contact
tanfang@eentanesthesia.com
8613611716000
Wenjing Yi
Contact
ywjeline@hotmail.com
8613636547402
Fang Tan
principal investigator · Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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