NCT07808125

Brief Summary

we conducted this multicentre retrospective cohort study to evaluate the association between the choice of induction agent (ciprofol versus propofol) and the incidence of IOH in geriatric patients having non-cardiac surgery. We hypothesized that ciprofol use would be associated with a lower risk of clinically significant intraoperative hypotension and a reduced overall hypotension burden compared with propofol in routine clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2013

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
Last Updated

September 8, 2026

Status Verified

August 1, 2026

Enrollment Period

11.8 years

First QC Date

September 3, 2026

Last Update Submit

September 3, 2026

Conditions

Keywords

CiprofolPropofolintraoperative hypotensiongeriatric anaesthesia

Outcome Measures

Primary Outcomes (1)

  • prolonged intraoperative hypotension

    The primary outcome was prolonged intraoperative hypotension (IOH) during general anaesthesia. IOH was defined as at least one intraoperative mean arterial pressure (MAP) measurement \<65 mm Hg recorded between anaesthesia induction and the end of anaesthesia.

    During the operation

Secondary Outcomes (3)

  • IOH burden at the event level

    During the operation

  • duration of individual IOH episodes

    During the operation

  • number of IOH episodes

    During the operation

Study Arms (2)

Ciprofol

Anesthetic induction for surgical procedures utilizing ciprofol as the sole induction agent

Propofol

Anesthetic induction for surgical procedures utilizing propofol as the sole induction agent

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This was a multicentre retrospective observational study of elderly patients aged 65 years or older who underwent non-cardiac surgery at three hospitals between 1 January 2013 and 1 September 2024. The analysis included surgical procedures performed under general anaesthesia in which either ciprofol alone or propofol alone was used. Procedures with missing key identifiers, uncertain general-anaesthesia status, absent event records, invalid anaesthesia times, or an anaesthesia duration of 24 hours or longer were excluded. Procedures without at least one valid intraoperative MAP measurement within the anaesthesia time window, as well as records with missing age or invalid sex information, were also excluded. Missing preoperative MAP values were not an exclusion criterion. The final analytical population comprised approximately 85,000 surgical procedures.

You may qualify if:

  • Surgical procedures recorded at the three participating hospitals: NanYi, AnYi, and ZhongDa
  • Surgical procedures with a non-missing PATIENT\_ID
  • Patients who received either ciprofol alone or propofol alone during anesthesia
  • Surgical procedures performed under general anesthesia
  • Surgical procedures with a corresponding record in the anesthesia event dataset
  • Surgical procedures with valid anesthesia start and end times, including times supplemented from operation-room or event records when necessary
  • Surgical procedures with an anesthesia duration greater than 0 minutes and less than 24 hours
  • Surgical procedures with at least one valid intraoperative MAP measurement recorded within the anesthesia time window
  • Patients with available age information
  • Patients with a recorded sex of male or female

You may not qualify if:

  • Surgical procedures with a missing PATIENT\_ID
  • Procedures involving both ciprofol and propofol, neither drug, missing drug indicators, or other invalid drug coding
  • Non-general anesthesia procedures or procedures for which the anesthesia method could not be confirmed as general anesthesia
  • Surgical procedures with both the operation department and operation name missing
  • Surgical procedures without a corresponding anesthesia event record
  • Surgical procedures with invalid anesthesia timing, including an anesthesia end time earlier than or equal to the anesthesia start time
  • Surgical procedures with an anesthesia duration of 24 hours or longer
  • Surgical procedures without any valid intraoperative MAP measurement within the anesthesia time window
  • Patients with missing age
  • Records with sex values other than male or female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

Location

Study Officials

  • Yali Ge

    Nanjing First Hospital, Nanjing Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 8, 2026

Study Start

January 1, 2013

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

September 8, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because this retrospective study uses existing hospital medical records containing sensitive clinical information. Data sharing is restricted by institutional policies and privacy considerations. De-identified aggregate results may be made available in the publication or from the corresponding author upon reasonable request, subject to institutional approval.

Locations