Pharmacokinetics of Sufentanil After Epidural Administration

NCT06069219 | Completed

• 2 other identifiers: 1144/182014/15/N/NZ7/03028
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Epidural; Anesthesia; Epidural Analgesia; Abdominal Surgery

Keywords

abdominal surgery; epidural analgesia; epidural anesthesia; pharmacokinetics; surgery patients; sufentanil

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  before the beginning of sufentanil administration, during sufentatnil administration, up to 72 hours after the cessation of sufentatnil administration

Study Arms (1)

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.

Drug: Epidural administration of sufentanil

Interventions

Epidural administration of sufentanil DRUG

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.

Also known as: Continuous epidural infusion of sufentanil

Adult patients received epidural sufentanil during and after abdominal surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The adult patients qualified to abdominal surgery performed in epidural anesthesia using sufentanil.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead
• Medical University of Gdansk: collaborator
• Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań: collaborator

Study Sites (2)

Heliodor Swiecicki Clinical Hospital in Poznan

Poznan, Greater Poland Voivodeship, 60-355, Poland

Location

Medical University of Gdansk

Gdansk, Pomeranian Voivodeship, 80-416, Poland

Location

Related Publications (1)

• 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.

  PMID: 40581890 DERIVED

Study Officials

• Edmund Grześkowiak, MSc, PhD

  Poznan University of Medical Sciences

  STUDY DIRECTOR

• Krzysztof Kusza, MD, PhD

  Heliodor Swiecicki Clinical Hospital in Poznan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 5, 2023
• Study Start: June 1, 2019
• Primary Completion: February 28, 2020
• Study Completion: January 31, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available in 12 months and available for 5 years
• Access Criteria: Scientists

Locations

PL (2)