Comparison of Esketamine-Propofol and Fentanyl-Propofol

NCT ID: NCT05752409

Last Updated: 2023-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-08

Study Completion Date

2023-12-31

Brief Summary

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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

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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

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Hemodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

The median dose of esketamine

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

The high dose of esketamine

Intervention Type DRUG

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

Propofol

2 mg•kg-1propofol, 1 μg•kg-1 fentanyl and 0.15 mg•kg-1 cis-atracurium was administered intravenously in one minute.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

Interventions

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The median dose of esketamine

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

Intervention Type DRUG

The high dose of esketamine

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

Intervention Type DRUG

Propofol

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

Intervention Type DRUG

Other Intervention Names

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s(+)ketamine s(+)ketamine Propofol 10 mg/ml Injection

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fang Tan

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

Locations

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Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fang Tan, Phd

Role: CONTACT

8613611716000

Wenjing Yi

Role: CONTACT

8613636547402

Facility Contacts

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Fang Tan

Role: primary

+8613611716000

References

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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.

Reference Type BACKGROUND
PMID: 35018643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34496448 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33841692 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36204220 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35914911 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32167978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35488787 (View on PubMed)

Other Identifiers

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esketamine-Propofol

Identifier Type: -

Identifier Source: org_study_id

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