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NCT Number: NCT06069219

Pharmacokinetics of Sufentanil After Epidural Administration

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Heliodor Swiecicki Clinical Hospital in Poznan, Poznan, Greater Poland Voivodeship, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Continuous epidural infusion of sufentanil

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Collaborators

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

Registry information

Official study title

Pharmacokinetics of Sufentanil After Epidural Administration in Patients Undergoing Abdominal Surgery

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Oct 5, 2023
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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