NCT06312345

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.

Trial Health

57
Monitor

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 Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 10, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 10, 2024

Last Update Submit

March 10, 2024

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)

Experimental: ciprofol

EXPERIMENTAL
Drug: Drug: ciprofol injection

Placebo Comparator: propofol

PLACEBO COMPARATOR
Drug: Drug: ciprofol injection

Interventions

Drug: ciprofol injectionDRUG

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

Experimental: ciprofolPlacebo 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

Related Publications (1)

  • Yu L, Liu X, Zhao X, Shan X, Bischof E, Lu HH. Ciprofol versus propofol for anesthesia induction in cardiac surgery: a randomized double-blind controlled clinical trial. BMC Anesthesiol. 2024 Nov 12;24(1):412. doi: 10.1186/s12871-024-02795-0.

    PMID: 39533186DERIVED

MeSH Terms

Interventions

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

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

March 10, 2024

First Posted

March 15, 2024

Study Start

March 11, 2024

Primary Completion

May 1, 2024

Study Completion

May 10, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations

CN(1)