Pharmacokinetics of Sufentanil After Epidural Administration

Abdominal Surgery Clinical Trial

Official title:

Pharmacokinetics of Sufentanil After Epidural Administration in Patients Undergoing Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06069219
• Other study ID #: 1144/18
• Secondary ID: 2014/15/N/NZ7/03
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: January 31, 2023

Study information

• Verified date: October 2023
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 31, 2023
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Surgery
• Epidural Analgesia
• Epidural; Anesthesia

Intervention

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.

Locations

Country	Name	City	State
Poland	Medical University of Gdansk	Gdansk	Pomeranian Voivodeship
Poland	Heliodor Swiecicki Clinical Hospital in Poznan	Poznan	Greater Poland

Sponsors (3)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences	Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznan, Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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