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

NCT05035069 | Unknown Phase 4

• 1 other identifier: HSK3486-IIT-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

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

  Day 1

Secondary Outcomes (4)

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

  Day 1

• Time from the end of drug infusion to the recovery of BIS to 90

  Day 1

• Percentage of subjects received rescue treatment

  Day 1

• Incidence of hypotension

  Day 1

Study Arms (2)

Ciprofol

EXPERIMENTAL

Drug: Ciprofol

Propofol

ACTIVE COMPARATOR

Drug: Propofol

Interventions

Ciprofol DRUG

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.

Ciprofol

Propofol DRUG

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.

Propofol

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Min Yan, M.D.

  Second Affiliated Hospital of Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fangqiong Li

CONTACT

+86 02867258840; lifangq@haisco.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 5, 2021
• Study Start: September 3, 2021
• Primary Completion: February 3, 2022
• Study Completion: February 4, 2022
• Last Updated: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)