Pharmacokinetics of Sufentanil After Epidural Administration

Sponsor

Poznan University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT06069219

Collaborator

Medical University of Gdansk (Other), Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań (Other)

Enrollment

Locations

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epidural; Anesthesia Epidural Analgesia Abdominal Surgery	Drug: Epidural administration of sufentanil

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 Design

Study Type:

Observational

Actual Enrollment :

18 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Pharmacokinetics of Sufentanil After Epidural Administration in Patients Undergoing Abdominal Surgery

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Feb 28, 2020

Actual Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	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. Other Names: Continuous epidural infusion of sufentanil

Arm

Intervention/Treatment

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.

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.

Other Names:

Continuous epidural infusion of sufentanil

Outcome Measures

Primary Outcome Measures

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.
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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heliodor Swiecicki Clinical Hospital in Poznan	Poznań	Greater Poland	Poland	60-355
2	Medical University of Gdansk	Gdańsk	Pomeranian Voivodeship	Poland	80-416

Sponsors and Collaborators

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

Investigators

Study Director: Edmund Grześkowiak, MSc, PhD, Poznan University of Medical Sciences
Study Director: Krzysztof Kusza, MD, PhD, Heliodor Swiecicki Clinical Hospital in Poznan