Exploration of the effects of fospropofol disodium in anesthesia induction for elderly hip surgery

ISRCTN	ISRCTN12170320
DOI	https://doi.org/10.1186/ISRCTN12170320
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	The First People's Hospital of Changzhou
Funder	The First People's Hospital of Changzhou

Submission date: 18/06/2025
Registration date: 24/06/2025
Last edited: 23/06/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This study looked at two medications,fospropofol disodium and etomidate. To determine whether fospropofol disodium can be effectively and safely used for anesthetic induction in elderly patients undergoing hip surgery.To assess whether fospropofol disodium provides superior hemodynamic stability compared to etomidate during anesthetic induction in elderly hip surgery patients.To compare the incidence of adverse events between fospropofol disodium and etomidate, specifically evaluating injection pain, myoclonus, and adrenal suppression.

Who can participate?
Elderly patients (65-74 years), BMI 18-27 kg/m², ASA physical status I-III, scheduled for hip surgery under general anesthesia requiring endotracheal intubation.

What does the study involve?
Participants were randomly placed into two groups. One group received fospropofol disodium, the other received etomidate

What are the possible benefits and risks of participating?
To optimize anesthetic induction and intraoperative management by maintaining hemodynamic stability, minimizing adverse events, simplifying medication regimens (including reduced maintenance doses), shortening recovery time, and accelerating postoperative rehabilitation.
As a water-soluble formulation, fospropofol disodium effectively mitigates injection pain, myoclonus, nausea/vomiting, and other adverse reactions, providing superior induction experience for patients.

Where is the study run from?
The First People's Hospital of Changzhou (China)

When is the study starting and how long is it expected to run for?
June 2025 to April 2026

Who is funding the study?
The First People's Hospital of Changzhou (China)

Who is the main contact?
qiulanmz@163.com

Contact information

Dr Lan Qiu
Public, Scientific, Principal investigator

The First People's Hospital of Changzhou
Changzhou
213000
China

Phone	+86 519-68870312
Email	qiulanmz@163.com

Study information

Primary study design	Interventional
Study design	Single-centre single-blinded prospective randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomized controlled trial of fospropofol disodium versus etomidate for anesthetic induction in elderly patients undergoing hip surgery: a randomized controlled trial
Study acronym	FDE-HF
Study objectives	Fospropofol disodium demonstrates safe and effective application for anesthetic induction in elderly patients undergoing hip surgery. Compared with the commonly used clinical induction agent etomidate, it provides greater hemodynamic stability, more effectively suppresses intubation-induced stress responses, and exhibits a lower incidence of complications such as myoclonus and injection pain.
Ethics approval(s)	Approved 07/05/2025, Ethics Committee of First People's Hospital of Changzhou (The First People's Hospital of Changzhou, Changzhou, 213000, China; +86 519-68870965; czyygcp@czfph.com), ref: 2025 CL059
Health condition(s) or problem(s) studied	Elderly hip surgery patients
Intervention	Patients were randomly allocated into two groups (1:1 ratio) using a computer-generated randomisation list created by an independent biostatistician before patient enrolment. Block randomisation was not used. Allocation was concealed, and both patients and outcome assessors were blinded to group assignments. Patients were randomly assigned to receive either intraoperative Fospropofol disodium infusion (10 mg/kg) or Etomidate infusion (0.3 mg/kg) The treatment duration is defined as the time from anesthesia induction until discharge from the post anesthesia care unit (PACU), and the follow-up period is 48 hours postoperatively
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Fospropofol disodium, etomidate
Primary outcome measure(s)	Time to loss of consciousness, measured by recording the interval from drug injection until both disappearance of the eyelash reflex and failure to respond to verbal command on two consecutive attempts
Key secondary outcome measure(s)	1. Hemodynamic parameters including heart rate, systolic, diastolic, and mean arterial pressure are measured using noninvasive monitoring at before induction of anesthesia, loss of consciousness ,immediately after tracheal intubation ,surgical incision,20 minutes after surgical incision 2. Side effects including postoperative nausea and vomiting are documented based on clinical observation and medication use within the first 24 hours 3. Recovery Time is recorded based on the time to extubation time after surgery 4. postoperative delirium is measured using a Confusion Assessment Method scale at 48 hours postoperatively 5. Success rate of anesthesia induction is measured using counting successful inductions as a proportion of the total number of participants in each group 6. Incidence of injection pain and myoclonus within 30 seconds of initial dose administration are documented based on clinical observation 7. Total dosage of sufentanil, remifentanil, propofol, and vasoactive drugs used is measured using data obtained from the intravenous device
Completion date	16/04/2026

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	65 Years
Upper age limit	74 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	1.Elderly patients (65-74 years) 2.BMI 18-27 kg/m² 3.ASA physical status I-III 4.Scheduled for hip surgery under general anesthesia requiring endotracheal intubation
Key exclusion criteria	1. Refusal of general anesthesia 2. Allergy to general anesthetics 3. Preoperative cognitive impairment or significant hepatic/renal dysfunction 4. Baseline blood pressure ≥180/110 mmHg or ≤90/60 mmHg 5. Symptomatic cardiovascular, cerebrovascular, or respiratory diseases 6. Scheduled for bilateral joint surgery 7. Revision arthroplasty 8. Polytrauma 9. History of systemic or regional anesthesia within 3 months
Date of first enrolment	20/06/2025
Date of final enrolment	20/10/2025

Locations

Countries of recruitment

China

Study participating centre

The First People's Hospital of Changzhou

Changzhou
213000
China

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from (Lan Qiu ,email address qiulanmz@163.com)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/06/2025: Trial's existence confirmed by Ethics Committee of First People's Hospital of Changzhou.