Intraoperative HypotensionNCT07808125
A Comparative Study Protocol Investigating the Association Between Intraoperative Hypotension and the Use of Ring- Versus Propofol-Based Anesthesia in Elderly Patients Undergoing Non-Cardiac Surgery
An observational study of Intraoperative Hypotension, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Intraoperative Hypotension
- How many people
- 85,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2013to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210006
About this study
Official title: Ciprofol is Associated With Lower Intraoperative Hypotension Than Propofol in Elderly Non-cardiac Surgical Patients: A Multicenter Retrospective Cohort Study
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.
Read the detailed description
Intraoperative hypotension (IOH) is a frequent and clinically significant complication during non-cardiac surgery, particularly in the geriatric population .On a population basis, the hypotensive harm threshold for AKI is a mean arterial pressure (MAP) of around 65 mm Hg. Maintaining MAP above this level during surgery is therefore recommended. Mounting evidence suggests that even brief periods of low arterial blood pressure are independently associated with an increased risk of postoperative myocardial injury acute kidney injury (AKI), and 30-day mortality . Elderly patients are uniquely vulnerable to these adverse outcomes due to age-related physiological decline, reduced cardiovascular reserve, and multiple comorbidities . Consequently, maintaining hemodynamic stability during the induction and maintenance of anaesthesia is a cornerstone of perioperative care in this fragile cohort .
Propofol remains the most widely utilized intravenous anesthetic agent worldwide ; however, its administration is frequently complicated by dose-dependent vasodilation and myocardial depression, leading to a high incidence of IOH . To mitigate these risks, ciprofol, a novel 2,6-disubstituted phenol derivative and GABA(A) receptor agonist, has been developed . While several studies and meta-analyses have demonstrated that ciprofol possesses higher potency and a more favorable safety profile compared with propofol , most evidence to date is derived from randomized controlled trials (RCTs) or specific procedural sedation settings. These studies often employ restrictive inclusion criteria and standardized protocols that may not fully reflect the complexities of real-world clinical practice.
The "real-world" impact of ciprofol on the incidence of IOH-especially when administered across diverse surgical settings and multi-institutional practices-remains poorly defined. Specifically, it is unclear whether ciprofol's theoretical pharmacological advantages translate into a lower incidence of IOH in elderly patients undergoing varied non-cardiac procedures in routine clinical care.
- Conditions
- Intraoperative Hypotension
- Keywords
- Ciprofol, Propofol, intraoperative hypotension, geriatric anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the operation
Secondary outcomes (3)
IOH burden at the event level
IOH burden at the event level, quantified as the area under the MAP threshold of 65 mm Hg (AUC, mm Hg·min), reflecting both the depth and duration of hypotension
Measured: During the operation
duration of individual IOH episodes
duration of individual IOH episodes
Measured: During the operation
number of IOH episodes
total number of IOH episodes per patient during surgery
Measured: During the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Jan 2013
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yali Ge, Study director, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808125
- Sponsor's protocol ID
- KY20260824-KS-03
- Status last verified
- Aug 2026
- First submitted
- 3 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ciprofol is Associated With Lower Intraoperative Hypotension Than Propofol in Elderly Non-cardiac Surgical Patients: A Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07808125
- Acronym / sponsor ID
- KY20260824-KS-03
- Conditions
- Intraoperative Hypotension
- Keywords
- Ciprofol, Propofol, intraoperative hypotension, geriatric anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85,000 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intraoperative hypotension (IOH) is a frequent and clinically significant complication during non-cardiac surgery, particularly in the geriatric population .On a population basis, the hypotensive harm threshold for AKI is a mean arterial pressure (MAP) of around 65 mm Hg. Maintaining MAP above this level during surgery is therefore recommended. Mounting evidence suggests that even brief periods of low arterial blood pressure are independently associated with an increased risk of postoperative myocardial injury acute kidney injury (AKI), and 30-day mortality . Elderly patients are uniquely vulnerable to these adverse outcomes due to age-related physiological decline, reduced cardiovascular reserve, and multiple comorbidities . Consequently, maintaining hemodynamic stability during the induction and maintenance of anaesthesia is a cornerstone of perioperative care in this fragile cohort .
Propofol remains the most widely utilized intravenous anesthetic agent worldwide ; however, its administration is frequently complicated by dose-dependent vasodilation and myocardial depression, leading to a high incidence of IOH . To mitigate these risks, ciprofol, a novel 2,6-disubstituted phenol derivative and GABA(A) receptor agonist, has been developed . While several studies and meta-analyses have demonstrated that ciprofol possesses higher potency and a more favorable safety profile compared with propofol , most evidence to date is derived from randomized controlled trials (RCTs) or specific procedural sedation settings. These studies often employ restrictive inclusion criteria and standardized protocols that may not fully reflect the complexities of real-world clinical practice.
The "real-world" impact of ciprofol on the incidence of IOH-especially when administered across diverse surgical settings and multi-institutional practices-remains poorly defined. Specifically, it is unclear whether ciprofol's theoretical pharmacological advantages translate into a lower incidence of IOH in elderly patients undergoing varied non-cardiac procedures in routine clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prolonged intraoperative hypotension
Time frame: During the operation
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.
3 secondary outcomes
IOH burden at the event level
Time frame: During the operation
duration of individual IOH episodes
Time frame: During the operation
number of IOH episodes
Time frame: During the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yali Ge study director
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Hypotension, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prolonged intraoperative hypotension (time frame: During the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.