Abdominal Surgery Clinical Trial
Official title:
Pharmacokinetics of Sufentanil After Epidural Administration in Patients Undergoing Abdominal Surgery
Verified date | October 2023 |
Source | Poznan University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Medical University of Gdansk | Gdansk | Pomeranian Voivodeship |
Poland | Heliodor Swiecicki Clinical Hospital in Poznan | Poznan | Greater Poland |
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 |
Poland,
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 |
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