Pharmacokinetics of Sufentanil After Epidural Administration

Completed

• Conditions: Epidural; Anesthesia; Epidural Analgesia; Abdominal Surgery
• Interventions: Drug: Epidural administration of sufentanil

• Registration Number: NCT06069219
• Lead Sponsor: Poznan University of Medical Sciences

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.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2020-02-28
• Study Completion: 2023-01-31
• Status Verified: 2023-10
• Study First Submitted: 2023-10-01
• Study First Submitted QC: 2023-10-01
• Last Update Submitted: 2023-10-01
• Study First Posted: 2023-10-05
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients received epidural sufentanil during and after abdominal surgery	Epidural administration of sufentanil	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.

Primary Outcome Measures

Name	Time	Method
Measurement of the depth of analgesia using NRS	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.
Systolic blood pressure	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.
Heart rate	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.
Sufentanil plasma concentrations [pg/ml]	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.
Diastolic blood pressure	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.

Trial Locations

Locations (2)

Heliodor Swiecicki Clinical Hospital in Poznan; 🇵🇱 Poznań, Greater Poland, Poland

Medical University of Gdansk; 🇵🇱 Gdańsk, Pomeranian Voivodeship, Poland