Exploration of the effects of fospropofol disodium in anesthesia induction for elderly hip surgery
| ISRCTN | ISRCTN12170320 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12170320 |
- Submission date
- 18/06/2025
- Registration date
- 24/06/2025
- Last edited
- 23/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
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
Public, Scientific, Principal Investigator
The First People's Hospital of Changzhou
Changzhou
213000
China
| Phone | +86 519-68870312 |
|---|---|
| qiulanmz@163.com |
Study information
| Study design | Single-centre single-blinded prospective randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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 |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Fospropofol disodium, etomidate |
| Primary outcome measure | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 16/02/2025 |
| Completion date | 16/04/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 65 Years |
| Upper age limit | 74 Years |
| Sex | Both |
| Target number of participants | 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
213000
China
Sponsor information
Hospital/treatment centre
The First People's Hospital of Changzhou
Changzhou
213000
China
| Phone | +83 13915089989 |
|---|---|
| czyygcp@czfph.com | |
| Website | http://www.czfph.com/default.asp |
"ROR" |
https://ror.org/01gaj0s81 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 20/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| 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) |
Editorial Notes
20/06/2025: Trial's existence confirmed by Ethics Committee of First People's Hospital of Changzhou.
