Clinical trial NCT06069219: Pharmacokinetics of Sufentanil After Epidural Administration
Official title: Pharmacokinetics of Sufentanil After Epidural Administration in Patients Undergoing Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epidural; Anesthesia
Epidural Analgesia
Abdominal Surgery
Keywords: abdominal surgery
epidural analgesia
epidural anesthesia
pharmacokinetics
surgery patients
sufentanil
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Medical University of Gdansk
name: Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań
First posted: 2023-10-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The adult patients qualified to abdominal surgery performed in epidural anesthesia using sufentanil.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* age 18-70 years,
* qualifications for abdominal surgery,
* ASA I-III

Exclusion Criteria:

* proven allergies to sufentanil,
* lack of written confirmed consent of a patient

Primary outcomes:
measure: Measurement of the depth of analgesia using NRS
timeFrame: before the beginning of sufentanil administration, during sufentatnil administration, up to 72 hours after sufentatnil administration
measure: Sufentanil plasma concentrations [pg/ml]
timeFrame: 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
measure: Systolic blood pressure
timeFrame: before the beginning of sufentanil administration, during sufentatnil administration, up to 72 hours after the cessation of sufentatnil administration
measure: Diastolic blood pressure
timeFrame: before the beginning of sufentanil administration, during sufentatnil administration, up to 72 hours after the cessation of sufentatnil administration
measure: Heart rate
timeFrame: before the beginning of sufentanil administration, during sufentatnil administration, up to 72 hours after the cessation of sufentatnil administration
Secondary outcomes:
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Heliodor Swiecicki Clinical Hospital in Poznan
state: Greater Poland
city: Gdańsk
country: Poland
facility: Medical University of Gdansk
state: Pomeranian Voivodeship
Study officials:
affiliation: Poznan University of Medical Sciences
name: Edmund Grześkowiak, MSc, PhD
role: STUDY_DIRECTOR
affiliation: Heliodor Swiecicki Clinical Hospital in Poznan
name: Krzysztof Kusza, MD, PhD
role: STUDY_DIRECTOR
References: