Epidural; AnesthesiaNCT06069219
Pharmacokinetics of Sufentanil After Epidural Administration
An observational study of Epidural; Anesthesia and Epidural Analgesia, run by Poznan University of Medical Sciences at 2 sites in Poland.
Trial summary
Sufentanil is an opioid analgesics used in all groups of patients. It has one of the strongest effects among analgesic drugs. Sufentanil is widely-used because of its very quick onset, short duration of action, and better hemodynamic stability in patients compared to other opioids. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epidural; Anesthesia, Epidural Analgesia, Abdominal Surgery
- What is being tested?
- Epidural administration of sufentanil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 18 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Jun 2019to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The adult patients qualified to abdominal surgery performed in epidural anesthesia using sufentanil.
Who may be able to join
- age 18-70 years,
- qualifications for abdominal surgery,
- ASA I-III
Who cannot join
- proven allergies to sufentanil,
- lack of written confirmed consent of a patient
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Medical University of Gdansk
Gdansk, Pomeranian Voivodeship, 80-416
Heliodor Swiecicki Clinical Hospital in Poznan
Poznan, Greater Poland Voivodeship, 60-355
About this study
Official title: Pharmacokinetics of Sufentanil After Epidural Administration in Patients Undergoing Abdominal Surgery
Sufentanil is an opioid analgesics used in all groups of patients. It has one of the strongest effects among analgesic drugs. Sufentanil is widely-used because of its very quick onset, short duration of action, and better hemodynamic stability in patients compared to other opioids. Most of the pharmacokinetic studies described intravenous administration of sufentanil. The drug can also be epidural administrated (especially continuous epidural infusion) in low concentration with local anesthetics (ropivacaine or bupivacaine) for epidural analgesia. Epidural analgesia offers effective pain relief not only during the surgery, but also postoperatively. The combination of two drugs provides their additive effect and can reduce doses required for pain relief, then decreases the number and severity of adverse events. The study aims to describe the pharmacokinetics of epidural sufentanil used perioperative in adult patients after abdominal surgery to adjust the dosage if necessary.
Read the detailed description
The patients qualified for abdominal surgery were enrolled in the study. All patients were premedicated with oral midazolam (7.5 mg). Epidural cannulations were placed by anesthesiologists before general anesthesia. The catheters' placement procedure was conducted under local anesthesia and according to the local protocol for the infections' prevention. The epidural infusion (solution of 0.2 % ropivacaine 5 ml with 25 to 50 mcg sufentanil in 50 ml of 0,9% NaCl) was started with a 5 mL bolus of the mentioned solution a few minutes before skin incision. The continuous infusion was maintained throughout the surgery at the rate of 3-12 mL/h. The patients were induced into general endotracheal anesthesia according to a standardized protocol, with propofol 1-3 mg/kg, fentanyl 1-2 mcg/kg, and rocuronium bromide 0.6 mg/kg. Anaesthesia was continued by using sevoflurane or desflurane MAC 1 to maintain mean arterial pressure with a value of +/- 20% of the original value. The postoperatively patients were monitored in the PACU (Post Anesthesia Care Unit) for 1 hour and then transferred to the intensive care unit or surgical unit according to their clinical status and co-morbidities. Whole blood samples (2.0 ml) were collected to measure sufentanil concentrations - during the epidural infusion and up to 72 hours after its cessation. Vital parameters (e.g. blood pressure, saturation, heart rate, respiratory rate, and pain score) were monitored at regular intervals. The epidural sufentanil and ropivacaine infusion were continued after surgery as long as was necessary.
- Conditions
- Epidural; Anesthesia, Epidural Analgesia, Abdominal Surgery
- Being tested
- Epidural administration of sufentanil
- Keywords
- abdominal surgery, epidural analgesia, epidural anesthesia, pharmacokinetics, surgery patients, sufentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural administration of sufentanilDrug
Also called Continuous epidural infusion of sufentanil
The epidural cannulations were placed by anesthesiologists before general anesthesia. Correct positioning of the catheters were tested and confirmed by negative aspiration and injection of 3 mL of 2% Lidocaine. The epidural infusion (solution of 0.2 % ropivacaine 5 ml with 25 to 50 mcg sufentanil in 50 ml of 0,9% NaCl) was started with bolus of 5 ml over 5 minutes and then continuous infusion was maintained was throughout the surgery at 3-12 mL/h and 2-12 mL/h after the surgery. Single dose of sufentanil was given when needed.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients received epidural sufentanil during and after abdominal surgery | All patients were premedicated with oral midazolam 7,5 mg and then they were induced into general endotracheal anesthesia according to a standardized protocol, with propofol 1-3 mg/kg, fentanyl 1-2 ug/kg and rocuronium bromide 0.6 mg/kg. Anaesthesia was continued with sevoflurane or desflurane MAC 1 to maintain mean arterial pressure with a value of +/- 20% of the original value. The epidural sufentanil infusion was started with bolus during anesthesia and continued after surgery as long as was necessary. Receives: Drug: Epidural administration of sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the depth of analgesia using NRS
Measurement of the depth of analgesia using NRS (Numeral Rating Scale) during epidural administration of sufentanil. Sufentanil was given for surgery patients during and after abdominal surgery as an analgesic agent.
Measured: before the beginning of sufentanil administration, during sufentatnil administration, up to 72 hours after sufentatnil administration
Sufentanil plasma concentrations [pg/ml]
Measurements of sufentanil plasma concentrations [pg/ml] during epidural analgesia with sufentanil. Whole blood samples (2.0 ml) were collected according to the study protocol.
Measured: 5, 30 minutes, 1, 2, 4, 6, 12 h after the begining of epidural infusion of sufentanil, then 1 blood samples every 24 h, just before the epidural infusion cessation and 3, 5, 20, 40 minutes, and 1, 2, 6, 12, 36, 72 hours after the infusion cessati
Systolic blood pressure
Measurements of systolic blood pressure during epidural analgesia with sufentanil.
Measured: before the beginning of sufentanil administration, during sufentatnil administration, up to 72 hours after the cessation of sufentatnil administration
Diastolic blood pressure
Measurements of diastolic blood pressure during epidural analgesia with sufentanil.
Measured: before the beginning of sufentanil administration, during sufentatnil administration, up to 72 hours after the cessation of sufentatnil administration
Heart rate
Measurements of heart rate during epidural analgesia with sufentanil.
Measured: before the beginning of sufentanil administration, during sufentatnil administration, up to 72 hours after the cessation of sufentatnil administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Jun 2019
- Primary completion28 Feb 2020
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epidural; AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Gdansk, Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań
- Responsible party
- Principal investigator, Agnieszka Bienert, Poznan University of Medical Sciences
- Investigators
- Edmund Grześkowiak, MSc, PhD, Study director, Poznan University of Medical SciencesKrzysztof Kusza, MD, PhD, Study director, Heliodor Swiecicki Clinical Hospital in Poznan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069219
- Sponsor's protocol ID
- 1144/18
- Other IDs
- 2014/15/N/NZ7/03028
- Status last verified
- Oct 2023
- First submitted
- 1 Oct 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data with analysis will be available after a publication of study results as a manuscript.
Publications
Bienert A, Moor AB, Okunska P, Ber J, Siluk D, Waszczuk M, Kusza K, Bartkowiak T, Szrama J, Kluzik A, Koszel T, Wiczling P. Pharmacokinetics of Sufentanil After Epidural Administration During the Course of Extensive Abdominal Surgery. Clin Pharmacokinet. 2025 Sep;64(9):1331-1340. doi: 10.1007/s40262-025-01543-y. Epub 2025 Jun 29.
PubMed 40581890
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Sufentanil After Epidural Administration in Patients Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06069219
- Acronym / sponsor ID
- 1144/18
- Conditions
- Epidural; Anesthesia, Epidural Analgesia, Abdominal Surgery
- Keywords
- abdominal surgery, epidural analgesia, epidural anesthesia, pharmacokinetics, surgery patients, sufentanil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Collaborators
- Medical University of Gdansk, Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sufentanil is an opioid analgesics used in all groups of patients. It has one of the strongest effects among analgesic drugs. Sufentanil is widely-used because of its very quick onset, short duration of action, and better hemodynamic stability in patients compared to other opioids. Most of the pharmacokinetic studies described intravenous administration of sufentanil. The drug can also be epidural administrated (especially continuous epidural infusion) in low concentration with local anesthetics (ropivacaine or bupivacaine) for epidural analgesia. Epidural analgesia offers effective pain relief not only during the surgery, but also postoperatively. The combination of two drugs provides their additive effect and can reduce doses required for pain relief, then decreases the number and severity of adverse events. The study aims to describe the pharmacokinetics of epidural sufentanil used perioperative in adult patients after abdominal surgery to adjust the dosage if necessary.
Detailed description
The patients qualified for abdominal surgery were enrolled in the study. All patients were premedicated with oral midazolam (7.5 mg). Epidural cannulations were placed by anesthesiologists before general anesthesia. The catheters' placement procedure was conducted under local anesthesia and according to the local protocol for the infections' prevention. The epidural infusion (solution of 0.2 % ropivacaine 5 ml with 25 to 50 mcg sufentanil in 50 ml of 0,9% NaCl) was started with a 5 mL bolus of the mentioned solution a few minutes before skin incision. The continuous infusion was maintained throughout the surgery at the rate of 3-12 mL/h. The patients were induced into general endotracheal anesthesia according to a standardized protocol, with propofol 1-3 mg/kg, fentanyl 1-2 mcg/kg, and rocuronium bromide 0.6 mg/kg. Anaesthesia was continued by using sevoflurane or desflurane MAC 1 to maintain mean arterial pressure with a value of +/- 20% of the original value. The postoperatively patients were monitored in the PACU (Post Anesthesia Care Unit) for 1 hour and then transferred to the intensive care unit or surgical unit according to their clinical status and co-morbidities. Whole blood samples (2.0 ml) were collected to measure sufentanil concentrations - during the epidural infusion and up to 72 hours after its cessation. Vital parameters (e.g. blood pressure, saturation, heart rate, respiratory rate, and pain score) were monitored at regular intervals. The epidural sufentanil and ropivacaine infusion were continued after surgery as long as was necessary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients received epidural sufentanil during and after abdominal surgery | – | Drug: Epidural administration of sufentanilAll patients were premedicated with oral midazolam 7,5 mg and then they were induced into general endotracheal anesthesia according to a standardized protocol, with propofol 1-3 mg/kg, fentanyl 1-2 ug/kg and rocuronium bromide 0.6 mg/kg. Anaesthesia was continued with sevoflurane or desflurane MAC 1 to maintain mean arterial pressure with a value of +/- 20% of the original value. The epidural sufentanil infusion was started with bolus during anesthesia and continued after surgery as long as was necessary. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The adult patients qualified to abdominal surgery performed in epidural anesthesia using sufentanil.
Key inclusion criteria (3 listed)
- age 18-70 years,
- qualifications for abdominal surgery,
- ASA I-III
Key exclusion criteria (2 listed)
- proven allergies to sufentanil,
- lack of written confirmed consent of a patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural administration of sufentanilAlso: Continuous epidural infusion of sufentanilThe epidural cannulations were placed by anesthesiologists before general anesthesia. Correct positioning of the catheters were tested and confirmed by negative aspiration and injection of 3 mL of 2% Lidocaine. The epidural infusion (solution of 0.2 % ropivacaine 5 ml with 25 to 50 mcg sufentanil in 50 ml of 0,9% NaCl) was started with bolus of 5 ml over 5 minutes and then continuous infusion was maintained was throughout the surgery at 3-12 mL/h and 2-12 mL/h after the surgery. Single dose of sufentanil was given when needed. | Drug | Adult patients received epidural sufentanil during and after abdominal surgery |
Primary outcome
Measurement of the depth of analgesia using NRS
Time frame: before the beginning of sufentanil administration, during sufentatnil administration, up to 72 hours after sufentatnil administration
Measurement of the depth of analgesia using NRS (Numeral Rating Scale) during epidural administration of sufentanil. Sufentanil was given for surgery patients during and after abdominal surgery as an analgesic agent.
Sufentanil plasma concentrations [pg/ml]
Time frame: 5, 30 minutes, 1, 2, 4, 6, 12 h after the begining of epidural infusion of sufentanil, then 1 blood samples every 24 h, just before the epidural infusion cessation and 3, 5, 20, 40 minutes, and 1, 2, 6, 12, 36, 72 hours after the infusion cessati
Measurements of sufentanil plasma concentrations [pg/ml] during epidural analgesia with sufentanil. Whole blood samples (2.0 ml) were collected according to the study protocol.
Systolic blood pressure
Time frame: before the beginning of sufentanil administration, during sufentatnil administration, up to 72 hours after the cessation of sufentatnil administration
Measurements of systolic blood pressure during epidural analgesia with sufentanil.
Diastolic blood pressure
Time frame: before the beginning of sufentanil administration, during sufentatnil administration, up to 72 hours after the cessation of sufentatnil administration
Measurements of diastolic blood pressure during epidural analgesia with sufentanil.
Heart rate
Time frame: before the beginning of sufentanil administration, during sufentatnil administration, up to 72 hours after the cessation of sufentatnil administration
Measurements of heart rate during epidural analgesia with sufentanil.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Derived from this study: PubMed 40581890Bienert A, Moor AB, Okunska P, Ber J, Siluk D, Waszczuk M, Kusza K, Bartkowiak T, Szrama J, Kluzik A, Koszel T, Wiczling P. Pharmacokinetics of Sufentanil After Epidural Administration During the Course of Extensive Abdominal Surgery. Clin Pharmacokinet. 2025 Sep;64(9):1331-1340. doi: 10.1007/s40262-025-01543-y. Epub 2025 Jun 29.
- Individual participant dataSharing planned: Yes. All data with analysis will be available after a publication of study results as a manuscript.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edmund Grześkowiak, MSc, PhD study director
Poznan University of Medical Sciences
Krzysztof Kusza, MD, PhD study director
Heliodor Swiecicki Clinical Hospital in Poznan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidural; Anesthesia and Epidural Analgesia, run by Poznan University of Medical Sciences at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the depth of analgesia using NRS (time frame: before the beginning of sufentanil administration, during sufentatnil administration, up to 72 hours after sufentatnil administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06069219, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.