NCT05752409

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 15, 2023

Status Verified

January 1, 2023

Enrollment Period

2.1 years

First QC Date

January 28, 2023

Last Update Submit

August 12, 2023

Conditions

Hemodynamics

Keywords

esketaminepropofolhemodynamic effectselderly patients

Outcome Measures

Primary Outcomes (25)

  • systolic blood pressure (T0)

    systolic blood pressure (SBP)

    before induction of anesthesia (T0; baseline)

  • systolic blood pressure (T1)

    systolic blood pressure (SBP)

    at the end of anaesthesia induction (T1)

  • systolic blood pressure (T2)

    systolic blood pressure (SBP)

    at the time before LMA insertion (T2)

  • systolic blood pressure (T3)

    systolic blood pressure (SBP)

    at the end of LMA insertion (T3)

  • systolic blood pressure (T4)

    systolic blood pressure (SBP)

    5min after LMA insertion (T4)

  • systolic blood pressure (T5)

    systolic blood pressure (SBP)

    10min after LMA insertion (T5)

  • diastolic blood pressure (T0)

    diastolic blood pressure (DBP)

    before induction of anesthesia (T0; baseline)

  • diastolic blood pressure (T1)

    diastolic blood pressure (DBP)

    at the end of anaesthesia induction (T1)

  • diastolic blood pressure (T2)

    diastolic blood pressure (DBP)

    at the time before LMA insertion (T2)

  • diastolic blood pressure (T3)

    diastolic blood pressure (DBP)

    at the end of LMA insertion (T3)

  • diastolic blood pressure (T4)

    diastolic blood pressure (DBP)

    5min after LMA insertion (T4)

  • diastolic blood pressure (T5)

    diastolic blood pressure (DBP)

    10min after LMA insertion (T5)

  • mean arterial pressure (T0)

    mean arterial pressure (MAP)

    before induction of anesthesia (T0; baseline)

  • mean arterial pressure (T1)

    mean arterial pressure (MAP)

    at the end of anaesthesia induction (T1)

  • mean arterial pressure (T2)

    mean arterial pressure (MAP)

    at the time before LMA insertion (T2)

  • mean arterial pressure (T3)

    mean arterial pressure (MAP)

    at the end of LMA insertion (T3)

  • mean arterial pressure (T4)

    mean arterial pressure (MAP)

    5min after LMA insertion(T4)

  • mean arterial pressure (T5)

    mean arterial pressure (MAP)

    10min after LMA insertion(T5)

  • heart rate (T0)

    heart rate (HR))

    before induction of anesthesia (T0; baseline)

  • heart rate (T1)

    heart rate (HR))

    at the end of anesthesia induction (T1)

  • heart rate (T2)

    heart rate (HR))

    at the time before LMA insertion (T2)

  • heart rate (T3)

    heart rate (HR))

    at the end of LMA insertion (T3)

  • heart rate (T4)

    heart rate (HR))

    5min after LMA insertion(T4)

  • heart rate (T5)

    heart rate (HR))

    10min after LMA insertion(T5)

  • the occurrence of hypotension

    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 Outcomes (1)

  • Recovery time

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

Study Arms (3)

Propofol + esketamin 0.5

EXPERIMENTAL

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

Propofol+ esketamin 0.75

EXPERIMENTAL

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

Propofol

ACTIVE COMPARATOR

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

The median dose of esketamineDRUG

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

Also known as: s(+)ketamine
Propofol + esketamin 0.5
The high dose of esketamineDRUG

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

Also known as: s(+)ketamine
Propofol+ esketamin 0.75
PropofolDRUG

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

Also known as: Propofol 10 mg/ml Injection
Propofol

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Related Publications (7)

  • 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.

    PMID: 35018643BACKGROUND

  • 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.

    PMID: 34496448BACKGROUND

  • 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.

    PMID: 33841692BACKGROUND

  • 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.

    PMID: 36204220BACKGROUND

  • 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.

    PMID: 35914911BACKGROUND

  • 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.

    PMID: 32167978BACKGROUND

  • 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.

    PMID: 35488787BACKGROUND

MeSH Terms

Interventions

KetamineEsketaminePropofolInjections

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, AromaticDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Fang Tan

    Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Tan, Phd

CONTACT

8613611716000tanfang@eentanesthesia.com

Wenjing Yi

CONTACT

8613636547402ywjeline@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2023

First Posted

March 2, 2023

Study Start

October 8, 2021

Primary Completion

November 30, 2023

Study Completion

December 31, 2023

Last Updated

August 15, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)