Clinical trial NCT06390046: Opioid-free Anesthesia, Optimization of Anesthesia After Bariatric Surgery
Official title: Opioid-free Anesthesia, Optimization of Anesthesia - Comparison of the Effectiveness of Analgesic and Antiemetic Effects in Patients After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesics, Opioid
Anesthesia; Adverse Effect
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study group will be male and female patients, ASA II or III, over 18 years of age and under 75 years of age. Each patient will undergo abdominal (bariatric) surgery.
Primary purpose: TREATMENT

Brief summary: Total intravenous general anesthesia and combined general anesthesia are recognized methods used during anesthesia. They allow you to effectively control pain and reduce the number of complications associated with taking large doses of opioid drugs. It should be emphasized that both methods of anesthesia are currently approved for use in routine anesthetic practice, and only the experience, knowledge and preferences of the anesthesiologist determine which technique will be used in a given patient. Both techniques are used in everyday anesthetic practice, but there is no conclusive scientific data confirming the superiority of either method in patients undergoing bariatric surgery, therefore currently only the individual experience, knowledge and preferences of the anesthesiologist determines which technique will be used in a given patient.

Detailed description: Patients undergoing bariatric surgery were randomly divided into two groups: one under complete intravenous anesthesia (infusion of Propofol, Ketamine, Lignocaine and Dexmedetomidine) and the other group under combined general anesthesia (infusion of Ketamine, Lignocaine and Dexmedetomidine and inhalation of Sevoflurane). In the postoperative period, all patients will receive Oxycodone NCA or in the form of oral tablets \[naloxone (naloxone hydrochloride) + oxycodone (oxycodone hydrochloride)\] and coanalgesics in the form of Paracetamol, Dexac, and Metamizol. Both methods of anesthesia are commonly used and used during bariatric and other surgical procedures. It should be emphasized once again that the above-mentioned all drugs are approved for routine use during anesthesia of patients, including obese patients, and our intervention only involves the use of a specific regimen from among those routinely available. The choice of anesthesia method depends on the anesthesiologist. During the study, we want to randomize patients into two groups: one will be anesthetized using a completely intravenous method, the other will be anesthetized using an inhalation anesthetic. Additionally, a video laryngoscope will be used to intubate half of the people for the first laryngoscopy, and a traditional laryngoscope for half of the patients, half of the patients will be randomized to each group. Both methods of visualizing the larynx and commonly used. Some centers use viedolaryngoskpie only in the case of so-called intubation. "difficult", i.e. one in which the use of a traditional laryngoscope does not allow intubation. Many bariatric surgery centers recommend the use of videolaryngoscopy routinely for the intubation of every bariatric patient. In the postoperative period, patients will have their pain level assessed using the NRS scale 1, 2, 6, 12 and 24 hours after the procedure.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years who underwent laparoscopic bariatric surgery

Exclusion Criteria:

Patients with a history of allergic reactions to drugs Patients with a history of drug addiction Patients with chronic pain who require analgesics History of hospitalization for psychiatric disorders Preoperative pulse oximetry (SpO2) \< 95 % bradycardia (HR\<50bpm), hypotension, atrioventricular block, intraventricular or sinus block Blood clotting disorders Pregnant/lactating women Cognitive impairment Unable to read consent

Primary outcomes:
measure: compare the effectiveness of analgesia
timeFrame: 2 days
measure: determine whether modern technologies such as videolaryngoscopy shorten intubation time.
timeFrame: 1 day
Secondary outcomes:
measure: incidence of postoperative nausea and vomiting
timeFrame: 1 days
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Jagiellonian University
state: Malopolskie
Study officials:
References: