Research on analgesia in mechanically ventilated patients following abdominal surgery
| ISRCTN | ISRCTN82186642 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82186642 |
- Submission date
- 02/04/2025
- Registration date
- 11/04/2025
- Last edited
- 10/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Postoperative pain management is essential to enhance rapid recovery in critically ill abdominal surgical patients. However, the optimal choice of analgesic agents for this specific patient population remains debatable. This study aimed to compare the effects and safety of sufentanil versus fentanyl for analgesia in critically ill abdominal surgical patients requiring mechanical ventilation.
Who can participate?
Patients aged between 18 and 85 years undergoing abdominal surgery with an expected duration of mechanical ventilation of under 72 hours
What does the study involve?
This study will allocate enrolled patients into two groups receiving fentanyl or sufentanil for analgesia, respectively. The following parameters will be systematically documented: baseline parameters, analgesia and sedation quality. Daily spontaneous breathing trials (SBTs) will be recorded for an extubation readiness assessment. The study will collect outcome data and monitor adverse events until patient discharge from the ICU. Through prospective comparative analysis, this study will evaluate the relative safety and effects of fentanyl versus sufentanil for pain management in mechanically ventilated patients after abdominal surgery.
What are the possible benefits and risks of participating?
No direct risks or benefits.
Where is the study run from?
West China Hospital of Sichuan University, China
When is the study starting and how long is it expected to run for?
September 2016 to September 2022
Who is funding the study?
West China Hospital, Sichuan University, China
Who is the main contact?
Dr Yongfang Zhou, zyfmg@163.com
Contact information
Public, Scientific, Principal Investigator
West China Hospital of Sichuan University, Guoxue Alley 37#, Wuhou District
Chengdu
610041
China
| Phone | +86-028-85422506 |
|---|---|
| zyfmg@163.com |
Study information
| Study design | Interventional randomized parallel-group controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Treatment, Safety, Efficacy |
| Scientific title | The efficacy and safety of sufentanil versus fentanyl for analgesia in mechanically ventilated patients after major abdominal surgery: a randomized controlled study |
| Study objectives | This study aimed to compare the efficacy and safety of sufentanil versus fentanyl for analgesia in critically ill abdominal surgical patients requiring mechanical ventilation. |
| Ethics approval(s) |
Approved 29/09/2016, The Ethics Committee of West China Hospital of Sichuan University (Guoxue Alley 37#, Wuhou District, Chengdu, 610041, China; +86-028-85423237; huaxilunli@163.com), ref: 2016 (208) |
| Health condition(s) or problem(s) studied | Patients receiving mechanical ventilation after abdominal surgery |
| Intervention | A random sequence is computer-generated and concealed in consecutively numbered, sealed, opaque envelopes by one study team member. Another member of the study team will open the envelope before each assignment. Eligible patients will be randomly assigned in a 1:1 ratio to receive either sufentanil or fentanyl. Analgesia in the sufentanil group Intervention: sufentanil Loading dose: 0.15-0.25 μg/kg Continuous maintenance dose: 0.1-0.3 μg/kg/hour The target analgesia level: CPOT score: 0 to 1 Analgesia in the sufentanil group Intervention: fentanyl Loading dose: 1.0-2.0 μg/kg Continuous maintenance dose: 1.0-2.0 μg/kg/hour The target analgesia level: CPOT score: 0 to 1 Sedation in both groups Intervention: propofol or dexmedetomidine Loading dose: 0.5-3.0 mg/kg(propofol), 0.5 μg/kg(dexmedetomidine) Continuous maintenance dose: 0.5-3.0 mg/kg/hour(propofol), 0.2-0.7 μg/kg/hour(dexmedetomidine) The target sedation level: RASS score: -2 to 0 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacodynamic, Pharmacoeconomic |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sufentanil, fentanyl |
| Primary outcome measure | Time from the cessation of sedation to awakening, defined as the recovery time, is measured using data collected from patient medical records at one-time point |
| Secondary outcome measures | The following secondary outcome measures are assessed using data collected from patient medical records at one time point: 1. Mechanical ventilation (MV) time, defined as the time from inclusion to extubation 2. Extubation time, defined as the time from the cessation of sedation to extubation 3. Duration of analgesia or sedation, defined as the time of study enrollment to the point of complete cessation of all pharmacological interventions in these categories 4. Duration of mechanical ventilation, defined as the time from intubation to extubation 5. Length of stay in the ICU, defined as the duration (in hours) from ICU admission to discharge, with admission and discharge time recorded to the nearest hour 6. Incidence of delirium: delirium occurrence was systematically monitored and recorded daily using the Confusion Assessment Method (CAM-ICU) by trained research staff 7. Abdominal distension, defined as the incidence of related adverse events (e.g. gastric retention, nausea, and vomiting): These events were prospectively documented for all patients from inclusion to ICU discharge 8. Incidence of related adverse events (e.g. gastric retention, nausea, and vomiting) |
| Overall study start date | 29/09/2016 |
| Completion date | 30/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 190 |
| Total final enrolment | 190 |
| Key inclusion criteria | 1. Patients receiving mechanical ventilation after abdominal surgery 2. Patients predicted to have a mechanical ventilation duration under 72 hours 3. Aged 18 - 85 years |
| Key exclusion criteria | 1. Known or suspected allergies to analgesics 2. Pregnancy or lactation 3. Consciousness disorders secondary to: 3.1. Metabolic diseases 3.2. Neurovascular diseases 3.3. Infections 3.4. Brain trauma 4. Unstable hemodynamics 5. Myasthenia gravis 6. Use of monoamine oxidase inhibitors within 14 days prior to enrollment 7. Bradycardia or severe heart block |
| Date of first enrolment | 01/12/2017 |
| Date of final enrolment | 30/09/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Chengdu
610041
China
Sponsor information
Hospital/treatment centre
Guoxue Alley 37#, Wuhou District
Chengdu
610041
China
| Phone | +86-028-85422114 |
|---|---|
| zhouyf2196@scu.edu | |
| Website | https://www.wchscu.cn/ |
"ROR" |
https://ror.org/007mrxy13 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- West China Hospital, West China School of Medicine and West China Hospital, Sichuan University, WCH, WCSM/WCH
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
10/04/2025: Study's existence confirmed by the Ethics Committee of West China Hospital of Sichuan University.
