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Pharmacokinetics of Sufentanil After Epidural Administration

NCT06069219 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2023-10-05

No results posted yet for this study

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • Medical University of Gdansk

    collaborator OTHER

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

    collaborator OTHER

  • Poznan University of Medical Sciences

    lead OTHER

Principal Investigators

  • Edmund Grześkowiak, MSc, PhD · Poznan University of Medical Sciences

  • Krzysztof Kusza, MD, PhD · Heliodor Swiecicki Clinical Hospital in Poznan

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2020-02-28
Completion
2023-01-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06069219 on ClinicalTrials.gov