Research on analgesia in mechanically ventilated patients following abdominal surgery

The efficacy and safety of sufentanil versus fentanyl for analgesia in mechanically ventilated patients after major abdominal surgery: a randomized controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN82186642

Enrollment

190

Registered

2025-04-11

Start date

2017-12-01

Completion date

Unknown

Last updated

2025-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients receiving mechanical ventilation after abdominal surgery Surgery

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

China

Contacts

Public ContactYongfang Zhou

zyfmg@163.com+86-028-85422506

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026