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

NCT06380244 | Recruiting DMC

• 1 other identifier: 1072.6120.136.2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Analgesics, Opioid; Anesthesia, Endotracheal; Anesthesia, General

Outcome Measures

Primary Outcomes (1)

• Pain level

  comparison of differences in pain levels. The numeric rating scale (NRS) will be used, it is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  2 days

Secondary Outcomes (1)

• Total long acting opioid consumption in oxycodone equivalents

  2 days

Study Arms (2)

Opioid

NO INTERVENTION

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.

OFA

EXPERIMENTAL

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.

Other: anesthesia without opioids

Interventions

anesthesia without opioids OTHER

Opioid free general anesthesia

OFA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's consent to participate in the study
• surgery within the abdominal cavity

You may not qualify if:

• patient's refusal to participate in the study
• inability to operate the PCA pump
• not understanding how the NRS scale works
• hypersensitivity to anesthetic drugs
• st or 2nd degree heart block.

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University

Krakow, Lesser Poland Voivodeship, 31501, Poland

RECRUITING

MeSH Terms

Interventions

Anesthesia; Analgesics, Opioid

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PHD

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 23, 2024
• Study Start: March 10, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available in 2026 for 1 year

Locations

PL (1)