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HemodynamicsNCT05752409

Comparison of Esketamine-Propofol and Fentanyl-Propofol

A study testing The median dose of esketamine, The high dose of esketamine and Propofol in people with Hemodynamics, run by Eye & ENT Hospital of Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Hemodynamics
What is being tested?
The median dose of esketamine, The high dose of esketamine and Propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
8 Oct 2021to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Fang Tan, Phd contact

8613611716000

tanfang@eentanesthesia.com

Wenjing Yi contact

8613636547402

ywjeline@hotmail.com

China1 site, 1 recruiting

  • Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200031

    Fang Tan, +8613611716000, tanfang@eentanesthesia.com

    Recruiting

Other trials in China

About this study

Official title: 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.

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.

Conditions
Hemodynamics
Being tested
The median dose of esketamine, The high dose of esketamine, Propofol
Keywords
esketamine, propofol, hemodynamic effects, elderly patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The median dose of esketamineDrug

    Also called s(+)ketamine

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

  • The high dose of esketamineDrug

    Also called s(+)ketamine

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

  • PropofolDrug

    Also called Propofol 10 mg/ml Injection

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

Study groups in NCT05752409
Study groupRoleWhat they receive
Propofol + esketamin 0.5Experimental1mg•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.
Receives: Drug: The median dose of esketamine
Propofol+ esketamin 0.75Experimental1mg•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.
Receives: Drug: The high dose of esketamine
PropofolActive comparator2 mg•kg-1propofol, 1 μg•kg-1 fentanyl and 0.15 mg•kg-1 cis-atracurium was administered intravenously in one minute.
Receives: Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. systolic blood pressure (T0)

    systolic blood pressure (SBP)

    Measured: before induction of anesthesia (T0; baseline)

  2. systolic blood pressure (T1)

    systolic blood pressure (SBP)

    Measured: at the end of anaesthesia induction (T1)

  3. systolic blood pressure (T2)

    systolic blood pressure (SBP)

    Measured: at the time before LMA insertion (T2)

  4. systolic blood pressure (T3)

    systolic blood pressure (SBP)

    Measured: at the end of LMA insertion (T3)

  5. systolic blood pressure (T4)

    systolic blood pressure (SBP)

    Measured: 5min after LMA insertion (T4)

  6. systolic blood pressure (T5)

    systolic blood pressure (SBP)

    Measured: 10min after LMA insertion (T5)

  7. diastolic blood pressure (T0)

    diastolic blood pressure (DBP)

    Measured: before induction of anesthesia (T0; baseline)

  8. diastolic blood pressure (T1)

    diastolic blood pressure (DBP)

    Measured: at the end of anaesthesia induction (T1)

  9. diastolic blood pressure (T2)

    diastolic blood pressure (DBP)

    Measured: at the time before LMA insertion (T2)

  10. diastolic blood pressure (T3)

    diastolic blood pressure (DBP)

    Measured: at the end of LMA insertion (T3)

  11. diastolic blood pressure (T4)

    diastolic blood pressure (DBP)

    Measured: 5min after LMA insertion (T4)

  12. diastolic blood pressure (T5)

    diastolic blood pressure (DBP)

    Measured: 10min after LMA insertion (T5)

  13. mean arterial pressure (T0)

    mean arterial pressure (MAP)

    Measured: before induction of anesthesia (T0; baseline)

  14. mean arterial pressure (T1)

    mean arterial pressure (MAP)

    Measured: at the end of anaesthesia induction (T1)

  15. mean arterial pressure (T2)

    mean arterial pressure (MAP)

    Measured: at the time before LMA insertion (T2)

  16. mean arterial pressure (T3)

    mean arterial pressure (MAP)

    Measured: at the end of LMA insertion (T3)

  17. mean arterial pressure (T4)

    mean arterial pressure (MAP)

    Measured: 5min after LMA insertion(T4)

  18. mean arterial pressure (T5)

    mean arterial pressure (MAP)

    Measured: 10min after LMA insertion(T5)

  19. heart rate (T0)

    heart rate (HR))

    Measured: before induction of anesthesia (T0; baseline)

  20. heart rate (T1)

    heart rate (HR))

    Measured: at the end of anesthesia induction (T1)

  21. heart rate (T2)

    heart rate (HR))

    Measured: at the time before LMA insertion (T2)

  22. heart rate (T3)

    heart rate (HR))

    Measured: at the end of LMA insertion (T3)

  23. heart rate (T4)

    heart rate (HR))

    Measured: 5min after LMA insertion(T4)

  24. heart rate (T5)

    heart rate (HR))

    Measured: 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.

    Measured: during general anesthesia, about 15 min.

Secondary outcomes (1)

  1. Recovery time

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

    Measured: from the time of completion of the procedure to the time of returning to the guard

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2023
  2. Study start8 Oct 2021
  3. Primary completion30 Nov 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05752409
Sponsor's protocol ID
esketamine-Propofol
Status last verified
Jan 2023
First submitted
28 Jan 2023
Last updated
15 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing The median dose of esketamine, The high dose of esketamine and Propofol in people with Hemodynamics, run by Eye & ENT Hospital of Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fang Tan, Phd (8613611716000, tanfang@eentanesthesia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

systolic blood pressure (T0) (time frame: before induction of anesthesia (T0; baseline)). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05752409, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.

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