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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06216210
Acronym
Mulimi
Enrollment
60
Registered
2024-01-22
Start date
2022-04-22
Completion date
2023-10-04
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use

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.

Interventions

DRUGopioid-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.,

DRUGopioid-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.

Sponsors

Zulekha Hospitals
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
immunological response20 MONTHSto detect the immunological response in the form of IL-2 and IL-6.

Secondary

MeasureTime frameDescription
The analgesic duration and requirements in the first twenty-four hours postoperatively20 MONTHSassessing the analgesic duration and requirements in the first twenty-four hours postoperatively
comparing the Visual Analog Score20 MONTHScomparing 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
The Non-Invasive blood pressure at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.20 MONTHSinvestigating the changes in blood pressure associated with the two different anesthetic techniques to determine the most suitable approach for bariatric surgery.
Heart rate at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.20 MONTHSinvestigating the changes in heart rate associated with the two different anesthetic techniques to determine the most suitable approach for bariatric surgery.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026