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

Completed

• Conditions: Opioid Use
• Interventions: Drug: opioid-FREE anesthesia.; Drug: opioid-CONTAINING anesthesia.

• Registration Number: NCT06216210
• Lead Sponsor: Zulekha Hospitals

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.

Study Timeline

• Study Start: 2022-04-22
• Primary Completion: 2023-10-04
• Study Completion: 2023-10-04
• Study First Submitted: 2023-12-26
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-19
• Last Update Submitted: 2024-01-19
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group (A)	opioid-FREE anesthesia.	Opioid-free anesthesia group
Group (B)	opioid-CONTAINING anesthesia.	Opioid-containing anesthesia group.

Primary Outcome Measures

Name	Time	Method
immunological response	20 MONTHS	to detect the immunological response in the form of IL-2 and IL-6.

Secondary Outcome Measures

Name	Time	Method
The analgesic duration and requirements in the first twenty-four hours postoperatively	20 MONTHS	assessing the analgesic duration and requirements in the first twenty-four hours postoperatively
The Non-Invasive blood pressure at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.	20 MONTHS	investigating the changes in blood pressure associated with the two different anesthetic techniques to determine the most suitable approach for bariatric surgery.
comparing the Visual Analog Score	20 MONTHS	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
Heart rate at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.	20 MONTHS	investigating the changes in heart rate associated with the two different anesthetic techniques to determine the most suitable approach for bariatric surgery.

Trial Locations

Locations (1)

Al-Azhar faculty of medicine; 🇪🇬 Cairo, Egypt