Opioid-free Anesthesia, Optimization of Anesthesia After Bariatric Surgery

Anesthesia; Adverse Effect Clinical Trial

Official title:

Opioid-free Anesthesia, Optimization of Anesthesia - Comparison of the Effectiveness of Analgesic and Antiemetic Effects in Patients After Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06390046
• Other study ID #: 1072.6120.135.2023
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Jagiellonian University
• Contact: Tomasz Skladzien, md phd
• Phone: 4001800
• Email: t.skladzien[@]interia.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesics, Opioid
• Anesthesia; Adverse Effect

Intervention

Procedure:
• Intubation
Comparing videao laryngospy with traditional laryngoscopy

Drug:
• TIVA versus Inhalation
comparing TIVA with genera anesthesia with inhalation agent

Locations

Country	Name	City	State
Poland	Jagiellonian University	Kraków	Malopolskie

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare the effectiveness of analgesia	NRS score after operation from 0 to 10	2 days
Primary	determine whether modern technologies such as videolaryngoscopy shorten intubation time.	measurment of intubation time in seconds	1 day
Secondary	incidence of postoperative nausea and vomiting	First day after operation is maesured in 1 hour, 2 hours, 6 hours, 12 hours and 24 hours after operation in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is assessed on a 7-point rating scale, anchored at one end by 1 = "Not at all nauseated" and at the other end by 7 = "Extremely nauseated."	2 days