Comparison of Esketamine-Propofol and Fentanyl-Propofol

Hemodynamics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752409
• Other study ID #: esketamine-Propofol
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Eye & ENT Hospital of Fudan University
• Contact: Fang Tan, Phd
• Phone: 8613611716000
• Email: tanfang[@]eentanesthesia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemodynamics

Intervention

Drug:
• The median dose of esketamine
1mg•kg-1propofol and 0.5 mg•kg-1esketamine for general anesthesia induction.
• The high dose of esketamine
1mg•kg-1propofol and 0.75 mg•kg-1esketamine for general anesthesia induction.
• Propofol
2mg•kg-1propofol for general anesthesia induction.

Locations

Country	Name	City	State
China	Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systolic blood pressure (T0)	systolic blood pressure (SBP)	before induction of anesthesia (T0; baseline)
Primary	systolic blood pressure (T1)	systolic blood pressure (SBP)	at the end of anaesthesia induction (T1)
Primary	systolic blood pressure (T2)	systolic blood pressure (SBP)	at the time before LMA insertion (T2)
Primary	systolic blood pressure (T3)	systolic blood pressure (SBP)	at the end of LMA insertion (T3)
Primary	systolic blood pressure (T4)	systolic blood pressure (SBP)	5min after LMA insertion (T4)
Primary	systolic blood pressure (T5)	systolic blood pressure (SBP)	10min after LMA insertion (T5)
Primary	diastolic blood pressure (T0)	diastolic blood pressure (DBP)	before induction of anesthesia (T0; baseline)
Primary	diastolic blood pressure (T1)	diastolic blood pressure (DBP)	at the end of anaesthesia induction (T1)
Primary	diastolic blood pressure (T2)	diastolic blood pressure (DBP)	at the time before LMA insertion (T2)
Primary	diastolic blood pressure (T3)	diastolic blood pressure (DBP)	at the end of LMA insertion (T3)
Primary	diastolic blood pressure (T4)	diastolic blood pressure (DBP)	5min after LMA insertion (T4)
Primary	diastolic blood pressure (T5)	diastolic blood pressure (DBP)	10min after LMA insertion (T5)
Primary	mean arterial pressure (T0)	mean arterial pressure (MAP)	before induction of anesthesia (T0; baseline)
Primary	mean arterial pressure (T1)	mean arterial pressure (MAP)	at the end of anaesthesia induction (T1)
Primary	mean arterial pressure (T2)	mean arterial pressure (MAP)	at the time before LMA insertion (T2)
Primary	mean arterial pressure (T3)	mean arterial pressure (MAP)	at the end of LMA insertion (T3)
Primary	mean arterial pressure (T4)	mean arterial pressure (MAP)	5min after LMA insertion(T4)
Primary	mean arterial pressure (T5)	mean arterial pressure (MAP)	10min after LMA insertion(T5)
Primary	heart rate (T0)	heart rate (HR))	before induction of anesthesia (T0; baseline)
Primary	heart rate (T1)	heart rate (HR))	at the end of anesthesia induction (T1)
Primary	heart rate (T2)	heart rate (HR))	at the time before LMA insertion (T2)
Primary	heart rate (T3)	heart rate (HR))	at the end of LMA insertion (T3)
Primary	heart rate (T4)	heart rate (HR))	5min after LMA insertion(T4)
Primary	heart rate (T5)	heart rate (HR))	10min after LMA insertion(T5)
Primary	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	Recovery time	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