Clinical trial NCT06216210: Assessing the Impact of Opioid-Free Anesthesia Using the Modified Mulimix Technique.
Official title: Assessing the Impact of Opioid-Free Anesthesia Using the Modified Mulimix Technique on Plasma Interleukin-2 and Interleukin-6 Levels in Bariatric Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use
Lead sponsor: Zulekha Hospitals
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A study was conducted on a sample of 60 patients, comprising individuals of both genders aged between 20 and 50 years.

Brief summary: The effective management of post-operative pain in the setting of bariatric surgery presents significant hurdles for both anesthesiologists and surgeons. The objective of this study was to assess the effects of opioid-free anesthesia (OFA) using the modified mulimix technique on the levels of plasma interleukin-2 (IL-2) and interleukin-6 (IL-6) as the primary outcome. Additionally, the study aimed to evaluate the duration of analgesia and the analgesic requirements within the first twenty-four hours after surgery.

Detailed description: Objectives: The effective management of post-operative pain in the setting of bariatric surgery presents significant hurdles for both anesthesiologists and surgeons. The objective of this study was to assess the effects of opioid-free anesthesia (OFA) using the modified mulimix technique on the levels of plasma interleukin-2 (IL-2) and interleukin-6 (IL-6) as the primary outcome. Additionally, the study aimed to evaluate the duration of analgesia and the analgesic requirements within the first twenty-four hours after surgery.

Methods: 60 patients were systematically selected and randomly assigned to Group A (OFA) and Group B (Opioid-Containing Anesthesia, OCA), with the modified Mulimix technique employed. Serum samples were collected from all patients, both at the onset of the skin incision and after the surgical procedure. These samples were then used to assess interleukin-2 (IL-2) and interleukin-6 (IL-6) levels. Additionally, the post-operative analgesic consumption was documented.

Eligibility criteria: Inclusion Criteria:

* both genders
* aged between 20 and 50 years
* patients fall under the American Society of Anesthesia (ASA) categories II-III
* body mass index (BMI) ranging from 35-50.

Exclusion Criteria:

* patients who declined participation in the trial
* pregnant women
* patients who encountered challenges in communication that could potentially impede a dependable postoperative evaluation

Primary outcomes:
measure: immunological response
timeFrame: 20 MONTHS
Secondary outcomes:
measure: The analgesic duration and requirements in the first twenty-four hours postoperatively
timeFrame: 20 MONTHS
measure: comparing the Visual Analog Score
timeFrame: 20 MONTHS
measure: The Non-Invasive blood pressure at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.
timeFrame: 20 MONTHS
measure: Heart rate at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.
timeFrame: 20 MONTHS
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar faculty of medicine
Study officials:
affiliation: assistant professor of anesthesiology, intensive care, and pain management, A-Azhar university
name: SAMEH HA SEYAM, MD
role: STUDY_CHAIR
References: