Assessing the Impact of Opioid-Free Anesthesia Using the Modified Mulimix Technique. (Mulimi)

Assessing the Impact of Opioid-Free Anesthesia Using the Modified Mulimix Technique on Plasma Interleukin-2 and Interleukin-6 Levels in Bariatric Surgery Patients

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use
• Intervention / Treatment: Drug: opioid-FREE anesthesia.; Drug: opioid-CONTAINING anesthesia.

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12546
    • Al-Azhar Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group (A); Opioid-free anesthesia group	Drug: opioid-FREE anesthesia.; They received opioid-free anesthesia. These patients were provided a multimodal combination infusion. The administration of this infusion commenced at a dosage of 0.2 micrograms per kilogram per hour of dexmedetomidine. The "Modified Mulimix" cocktail, consisting of dexmedetomidine at a concentration of 10 ug/ml, Ketamine at a concentration of 2.5 mg/ml, and Lignocaine at a concentration of 20 mg/ml, was administered to a patient weighing 100 kg and if the weight is 110 Kg the rate will be increased by 10 percent, etc.,; Other Names: GROUP (A)
Group (B); Opioid-containing anesthesia group.	Drug: opioid-CONTAINING anesthesia.; The process of inducing anesthesia included the injection of fentanyl at a dosage of 2 micrograms per kilogram during the induction phase. Additionally, morphine was administered at a dose of 0.03 milligrams per kilogram at the time of port insertion.; Other Names: GROUP (B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
immunological response	to detect the immunological response in the form of IL-2 and IL-6.	20 MONTHS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The analgesic duration and requirements in the first twenty-four hours postoperatively	assessing the analgesic duration and requirements in the first twenty-four hours postoperatively	20 MONTHS
comparing the Visual Analog Score	comparing the Visual Analog Score between opioid-free anesthesia and opioid-contained. anesthesia. scale values from 0 to 100. from 0 to 4 considered no pain	20 MONTHS
The Non-Invasive blood pressure at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.	investigating the changes in blood pressure associated with the two different anesthetic techniques to determine the most suitable approach for bariatric surgery.	20 MONTHS
Heart rate at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.	investigating the changes in heart rate associated with the two different anesthetic techniques to determine the most suitable approach for bariatric surgery.	20 MONTHS

Collaborators and Investigators

• Sponsor: Zulekha Hospitals
• Investigators: Study Chair: SAMEH HA SEYAM, MD, assistant professor of anesthesiology, intensive care, and pain management, A-Azhar university

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2022
• Primary Completion (Actual): October 4, 2023
• Study Completion (Actual): October 4, 2023

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Anesthetics; Analgesics, Opioid
• Other Study ID Numbers: T.G.H.45/275

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No