NCT05892471

Brief Summary

Ciprofol, a novel intravenous general anesthetic with a chemical structure akin to propofol, boasts significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and minor impact on the cardiovascular system. However, clinical research regarding ciprofol's use for anesthesia induction in cardiac surgery remains limited. The investigators want to assesse the safety and effectiveness of ciprofol in cardiac surgery anesthesia

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

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

August 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

May 17, 2023

Last Update Submit

June 6, 2023

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (8)

  • Mean arterial pressure

    an average blood pressure in an individual during a single cardiac cycle

    1 second before induction of anesthesia (T1)

  • Mean arterial pressure

    an average blood pressure in an individual during a single cardiac cycle

    1 second before tracheal intubation (T2)

  • Mean arterial pressure

    an average blood pressure in an individual during a single cardiac cycle

    1 minute after tracheal intubation (T3)

  • Mean arterial pressure

    an average blood pressure in an individual during a single cardiac cycle

    5 minutes after tracheal intubation (T4)

  • Heart beats

    the number of times each minute that heart beats

    1 second before induction of anesthesia (T1)

  • Heart beats

    the number of times each minute that heart beats

    1 second before tracheal intubation (T2)

  • Heart beats

    the number of times each minute that heart beats

    1 minute after tracheal intubation (T3)

  • Heart beats

    the number of times each minute that heart beats

    5 minutes after tracheal intubation (T4).

Secondary Outcomes (3)

  • Oxygenation index

    1 second before induction of anesthesia (T1)

  • Oxygenation index

    10 minutes after tracheal intubation (T5).

  • Injection pain

    During procedure (When injecting the drug, ask the subject if the injection site is painful)

Study Arms (2)

ciprofol

EXPERIMENTAL
Drug: ciprofol injection

propofol

PLACEBO COMPARATOR
Drug: Propofol injection

Interventions

ciprofol injectionDRUG

Patients in ciprofol group 0.3 mg/kg ciprofol for induction of anesthesia

Also known as: Experimental
ciprofol
Propofol injectionDRUG

Patients in propofol group received 1.5 mg/kg propofol for induction of anesthesia

Also known as: Placebo Comparator
propofol

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective surgery patients
  • Aged 55 to 75
  • New York Heart Association class II or III cardiac functions
  • Median sternotomy approach for coronary artery bypass grafting or heart valve replacement procedures.

You may not qualify if:

  • With a history of benzodiazepine allergy
  • Significant liver or kidney insufficiency
  • Coagulation dysfunction
  • Neurological or psychiatric disorders
  • Undergone major surgery within the past three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital of Tongji University

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

MeSH Terms

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenolPropofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Handong Sun

    Shanghai East Hospital of Tongji University

    STUDY DIRECTOR

Central Study Contacts

LE YU

CONTACT

19921875120907084943@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinicians

Study Record Dates

First Submitted

May 17, 2023

First Posted

June 7, 2023

Study Start

August 1, 2022

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

June 7, 2023

Record last verified: 2023-06

Locations

CN(1)