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

Opioid Use Clinical Trial

— Mulimi  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06216210
• Other study ID #: T.G.H.45/275
• Status: Completed
• Start date: April 22, 2022
• Est. completion date: October 4, 2023

Study information

• Verified date: January 2024
• Source: Zulekha Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 4, 2023
• Est. primary completion date: October 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use

Intervention

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.,
• 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.

Locations

Country	Name	City	State
Egypt	Al-Azhar faculty of medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Zulekha Hospitals

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immunological response	to detect the immunological response in the form of IL-2 and IL-6.	20 MONTHS
Secondary	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
Secondary	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
Secondary	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
Secondary	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