Research on analgesia in mechanically ventilated patients following abdominal surgery

ISRCTN	ISRCTN82186642
DOI	https://doi.org/10.1186/ISRCTN82186642
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	West China Hospital of Sichuan University
Funder	West China Hospital, Sichuan University

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Yongfang Zhou
Public, Scientific, Principal investigator

West China Hospital of Sichuan University, Guoxue Alley 37#, Wuhou District
Chengdu
610041
China

Phone	+86-028-85422506
Email	zyfmg@163.com

Study information

Primary study design	Interventional
Study design	Interventional randomized parallel-group controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Sufentanil, fentanyl
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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)
Completion date	30/09/2022

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	85 Years
Sex	All
Target sample size at registration	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

West China Hospital of Sichuan University

Guoxue Road 37#,Wuhou District
Chengdu
610041
China

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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.