Skip to main content
OpenTrials
Completed

NCT Number: NCT07808125

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. IOH burden at the event level

    Time frame: During the operation

    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

  2. duration of individual IOH episodes

    Time frame: During the operation

    duration of individual IOH episodes

  3. number of IOH episodes

    Time frame: During the operation

    total number of IOH episodes per patient during surgery

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2024
Study completion
2024
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.