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Status unknownNCT05035069Updated Sep 5, 2021

Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR

A Phase 4 interventional study of Ciprofol and Propofol in Anesthesia, General, sponsored by Haisco Pharmaceutical Group Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-09-05.

Sponsored by Haisco Pharmaceutical Group Co., Ltd. · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
65 Years to 85 Years
Sex
All
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Study summary

The purpose of this study is to explore the efficacy and safety of ciprofol compared to propofol for non-intubated general anesthesia in patients undergoing transcatheter aortic valve replacement (TAVR).

Read the detailed description

This is a study in subjects undergoing transcatheter aortic valve replacement (TAVR). As designed, the study will include 1-day screening period, 1-day observation period, and 1-day safety follow-up. Participants will be randomly assigned to either experimental or control group with a 1:1 allocation, with 12 subjects in each group.

02

Conditions studied

  • Anesthesia, General
03

In context

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd. is the lead sponsor of 114 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient scheduled for TAVR through femoral artery access
  • 1h ≤ Expected duration of surgery ≤ 3h
  • Planned for general anesthesia without intubation
  • 18 ≤ BMI ≤ 30
  • ASA category Ⅱ～Ⅳ

Exclusion criteria

Exclusion Criteria:

  • Contraindications to anesthesia/sedation or a history of adverse reaction to anesthesia/sedation
  • Known allergies to eggs, soy products, opioids and their antidotes, propofol, etc; Contraindications of propofol, opioids and their antidotes
  • Shock and hypotension difficult that is to be corrected by vasoactive drugs in the screening period
  • Hemoglobin (HB) \< 10.0 g / dl (100 g / L)
  • Judged by the investigator to have any other factors that make the subject unsuitable for participation in the study.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Ciprofol

    Drug: Ciprofol

  • Active comparator
    Propofol

    Drug: Propofol

Interventions

  • DrugCiprofol

    Ciprofol infusion, starting with 0.8 \~ 1mg/kg/h until BIS value below 60 (including 60), and then 0.2 \~ 0.6mg/kg/h until the end of the operation, ciprofol infusion was adjusted to keep the BIS value between 40-60.

  • DrugPropofol

    Propofol infusion, starting with 4 \~ 5mg/kg/h until BIS value below 60 (including 60), and then 1 \~ 3mg/kg/h until the end of the operation, propofol infusion was adjusted to keep the BIS value between 40-60.

06

What researchers measure

Primary outcomes

  1. Percentage of time that BIS value is maintained between 40 and 60 (including boundary value)

    Time frame: Day 1

Secondary outcomes

  1. Time from the start of drug infusion to the first BIS reduction to 60

    Time frame: Day 1

  2. Time from the end of drug infusion to the recovery of BIS to 90

    Time frame: Day 1

  3. Percentage of subjects received rescue treatment

    Time frame: Day 1

  4. Incidence of hypotension

    Time frame: Day 1

07

Study locations

1 site
  • Second Affiliated Hospital of Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310009, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05035069
Lead sponsor
Haisco Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Sep 5, 2021
Start date
Sep 3, 2021 (estimated)
Primary completion
Feb 3, 2022 (estimated)
Completion
Feb 4, 2022 (estimated)
Last update
Sep 5, 2021

Study contacts

Fangqiong Li
Contact
lifangq@haisco.com
+86 02867258840
Min Yan, M.D.
principal investigator · Second Affiliated Hospital of Zhejiang University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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