NCT05706337

Brief Summary

To evaluate the effect of ciprofol anesthesia Induction on hemodynamics in elderly patients undergoing elective noncardiac surgery，a prospective, randomized, controlled trial.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_4

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

First Submitted

Initial submission to the registry

November 29, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

November 29, 2022

Last Update Submit

January 20, 2023

Conditions

AnesthesiaPainHemodynamic Instability

Keywords

Anesthesia inductionCiprofolpropofolInjection pain

Outcome Measures

Primary Outcomes (3)

  • Hemodynamic changes：Systolic blood pressure (SBP)

    Systolic blood pressure (SBP) during anesthesia induction

    From the beginning of drug administration to 30 minutes after intubation

  • Hemodynamic changes: Diastolic blood pressure(DBP)

    Diastolic blood pressure(DBP) during anesthesia induction

    From the beginning of drug administration to 30 minutes after intubation

  • Hemodynamic changes: Heart rate （HR ）

    Heart rate （HR ）during anesthesia induction

    From the beginning of drug administration to 30 minutes after intubation

Secondary Outcomes (8)

  • adverse reactions: injection pain

    anesthesia induction

  • adverse reactions: muscle fasciculation

    anesthesia induction

  • adverse reactions：arrhythmia

    anesthesia induction

  • perioperative hepatic function: Aspartate Aminotransferase ( AST)

    Before surgery , 1day after operation

  • perioperative hepatic function: Alanine Aminotransferase ( ALT)

    Before surgery , 1day after operation

  • +3 more secondary outcomes

Study Arms (2)

propofol group

ACTIVE COMPARATOR

According to grouping，patients were premeditated with injection of Propofol 1-2mg / kg IV . If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is \>60, propofol 0.5mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil.

Drug: Propofol

ciprofol group

EXPERIMENTAL

According to grouping，patients were premeditated with injection of ciprofol 0.2-0.5mg/kg IV. If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is \>60, ciprofol 0.1mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil in both groups.

Drug: Ciprofol

Interventions

PropofolDRUG

Propofol 1-2mg / kg was for anesthesia induction. Propofol is a hypnotic agent that is used as an induction agent and as a maintenance anaesthetic delivered by continuous i.v. infusion or intermittent i.v. bolus.

propofol group
CiprofolDRUG

Ciprofol 0.2～0.5mg/kg was for anesthesia induction. Ciprofol is an intravenous sedative-hypnotic and a short-acting GABAA receptor agonist. It activates GABAergic neurons by enhancing chloride ion influx. It is used for anesthetic induction and maintenance agents include rapid induction of general anesthesia, rapid return of consciousness, minimal residual effects on the central nervous system and less injection pain.

ciprofol group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ASA physical status Ⅰ-Ⅲ
  • Age over 65 years;
  • Body mass index (BMI) 20 \~ 30 kg/m2 ;
  • Elective noncardiac surgery;

You may not qualify if:

  • The patient or his/her family refused to participate in the clinical trial;
  • Severe heart, lung, liver or kidney dysfunction;
  • Expected difficult airway, requiring awake tracheal intubation;
  • Those who are allergic to the drugs used in this study;
  • Unsuccessful tracheal intubation twice;
  • Patients with mental illness or impaired consciousness;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Teng Y, Ou M, Wang X, Zhang W, Liu X, Liang Y, Li K, Wang Y, Ouyang W, Weng H, Li J, Yao S, Meng J, Shangguan W, Zuo Y, Zhu T, Liu B, Liu J. Efficacy and safety of ciprofol for the sedation/anesthesia in patients undergoing colonoscopy: Phase IIa and IIb multi-center clinical trials. Eur J Pharm Sci. 2021 Sep 1;164:105904. doi: 10.1016/j.ejps.2021.105904. Epub 2021 Jun 8.

    PMID: 34116176BACKGROUND

  • Wang X, Wang X, Liu J, Zuo YX, Zhu QM, Wei XC, Zou XH, Luo AL, Zhang FX, Li YL, Zheng H, Li H, Wang S, Wang DX, Guo QL, Liu CM, Wang YT, Zhu ZQ, Wang GY, Ai YQ, Xu MJ. Effects of ciprofol for the induction of general anesthesia in patients scheduled for elective surgery compared to propofol: a phase 3, multicenter, randomized, double-blind, comparative study. Eur Rev Med Pharmacol Sci. 2022 Mar;26(5):1607-1617. doi: 10.26355/eurrev_202203_28228.

    PMID: 35302207BACKGROUND

  • Qin K, Qin WY, Ming SP, Ma XF, Du XK. Effect of ciprofol on induction and maintenance of general anesthesia in patients undergoing kidney transplantation. Eur Rev Med Pharmacol Sci. 2022 Jul;26(14):5063-5071. doi: 10.26355/eurrev_202207_29292.

    PMID: 35916802BACKGROUND

Related Links

MeSH Terms

Conditions

Pain

Interventions

Propofol(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Xiumei Song, Doctor

    Qian fo shan hospitial of shan dong province, China

    STUDY CHAIR

Central Study Contacts

Xiumei Song, Doctor

CONTACT

+8613969050425ssm801117@163.com

Jinwan Guo, Master

CONTACT

_+8617686830961guojinwan2010@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

November 29, 2022

First Posted

January 31, 2023

Study Start

February 1, 2023

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

We plan to upload and share data with other researchers. Protecting patient privacy when sharing patient-level data from clinical trial

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
study protocol and Informed Consent Form will available before 2024/1/1 Statistical Analysis Plan and Clinical Study Report will available before 2024/6/1
Access Criteria
All registered researchers