Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Due to the increasing number of reports of cancer progression in people undergoing surgery under general anesthesia using opioids, OFA is believed to have a favorable long-term prognostic effect, especially in cancer patients. The opioid-free protocol is also used in postoperative analgesia. It is estimated that up to 75% of surgical patients experience chronic postoperative pain, which has a particularly negative impact on the quality of life. The investigators would like to compare pain during the first 48 postoperative hours of patients undergoing abdominal surgery who would be anesthetized with opioids and without opioids (patients would be randomly assigned to a group) (1, 2, 6, 12, 24 and 48 h after operations). A secondary objective will be to measure total oxycodone consumption in the postoperative period in both groups. Other secondary objectives: assessment of postoperative nausea and vomiting (PONV).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patient's consent to participate in the study

• surgery within the abdominal cavity

Locations
Other Locations
Poland
Jagiellonian University
RECRUITING
Krakow
Time Frame
Start Date: 2024-03-10
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
No_intervention: Opioid
general anesthesia (using remifentanil infusion intraoperatively). Standard monitoring during anaesthesia included arterial oxygen saturation, ECG, and non-invasive arterial blood pressure. Premedication was not used. The standard anaesthesia consisted of propofol (1.5-2 mg / kg body weight iv) and for induction. Infusion of remifentanil in a plasma target control infusion with a calculated plasma level of 1-6 ng/ml. Rocuronium (0.6 mg / kg body weight iv) was administered prior to intubation. AThe painkillers used would be metamizole, acetaminophen and oxycodone.
Experimental: OFA
completely anesthetized without opioids (infusion of Ketamine, Lignocaine and Dexmedetomidine. Standard monitoring during anaesthesia included arterial oxygen saturation, ECG, and non-invasive arterial blood pressure. Premedication was not used. The standard anaesthesia consisted of propofol (1.5-2 mg / kg body weight iv) and for induction. Rocuronium (0.6 mg / kg body weight iv) was administered prior to intubation. The painkillers used would be metamizole, acetaminophen and oxycodone.
Related Therapeutic Areas
Sponsors
Leads: Jagiellonian University

This content was sourced from clinicaltrials.gov