Skip to content

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

Ciprofol is Associated With Lower Intraoperative Hypotension Than Propofol in Elderly Non-cardiac Surgical Patients: A Multicenter Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07808125
Enrollment
85000
Registered
2026-09-08
Start date
2013-01-01
Completion date
2024-09-30
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Hypotension

Keywords

Ciprofol, Propofol, intraoperative hypotension, geriatric anaesthesia

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.

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.

Interventions

None listed

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Surgical procedures recorded at the three participating hospitals: NanYi, AnYi, and ZhongDa 2. Surgical procedures with a non-missing PATIENT\_ID 3. Patients who received either ciprofol alone or propofol alone during anesthesia 4. Surgical procedures performed under general anesthesia 5. Surgical procedures with a corresponding record in the anesthesia event dataset 6. Surgical procedures with valid anesthesia start and end times, including times supplemented from operation-room or event records when necessary 7. Surgical procedures with an anesthesia duration greater than 0 minutes and less than 24 hours 8. Surgical procedures with at least one valid intraoperative MAP measurement recorded within the anesthesia time window 9. Patients with available age information 10. Patients with a recorded sex of male or female

Exclusion criteria

1. Surgical procedures with a missing PATIENT\_ID 2. Procedures involving both ciprofol and propofol, neither drug, missing drug indicators, or other invalid drug coding 3. Non-general anesthesia procedures or procedures for which the anesthesia method could not be confirmed as general anesthesia 4. Surgical procedures with both the operation department and operation name missing 5. Surgical procedures without a corresponding anesthesia event record 6. Surgical procedures with invalid anesthesia timing, including an anesthesia end time earlier than or equal to the anesthesia start time 7. Surgical procedures with an anesthesia duration of 24 hours or longer 8. Surgical procedures without any valid intraoperative MAP measurement within the anesthesia time window 9. Patients with missing age 10. Records with sex values other than male or female

Design outcomes

Primary

MeasureTime frameDescription
prolonged intraoperative hypotensionDuring the operationThe 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.

Secondary

MeasureTime frameDescription
IOH burden at the event levelDuring the operationIOH 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
duration of individual IOH episodesDuring the operationduration of individual IOH episodes
number of IOH episodesDuring the operationtotal number of IOH episodes per patient during surgery

Countries

China

Contacts

STUDY_DIRECTORYali Ge

Nanjing First Hospital, Nanjing Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026