Pharmacokinetics of Sufentanil After Epidural Administration

NCT ID: NCT06069219

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2023-01-31

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.

Conditions

Epidural; Anesthesia; Epidural Analgesia; Abdominal Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Epidural administration of sufentanil

Intervention Type: 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.

Interventions

Epidural administration 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.

Intervention Type: DRUG

Other Intervention Names

Continuous epidural infusion of sufentanil

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Gdansk

OTHER

Sponsor Role: collaborator

Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań

OTHER

Sponsor Role: collaborator

Poznan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Agnieszka Bienert

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edmund Grześkowiak, MSc, PhD

Role: STUDY_DIRECTOR

Poznan University of Medical Sciences

Krzysztof Kusza, MD, PhD

Role: STUDY_DIRECTOR

Heliodor Swiecicki Clinical Hospital in Poznan

Locations

Heliodor Swiecicki Clinical Hospital in Poznan

Poznan, Greater Poland Voivodeship, Poland

Medical University of Gdansk

Gdansk, Pomeranian Voivodeship, Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 40581890 (View on PubMed)

Other Identifiers

2014/15/N/NZ7/03028

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1144/18

Identifier Type: -

Identifier Source: org_study_id