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Clinical Trials/NCT06216210
NCT06216210
Completed
Not Applicable

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

Zulekha Hospitals1 site in 1 country60 target enrollmentApril 22, 2022

Overview

Phase
Not Applicable
Intervention
opioid-FREE anesthesia.
Conditions
Opioid Use
Sponsor
Zulekha Hospitals
Enrollment
60
Locations
1
Primary Endpoint
immunological response
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 22, 2022
End Date
October 4, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Zulekha Hospitals
Responsible Party
Sponsor

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

Arms & Interventions

Group (A)

Opioid-free anesthesia group

Intervention: opioid-FREE anesthesia.

Group (B)

Opioid-containing anesthesia group.

Intervention: opioid-CONTAINING anesthesia.

Outcomes

Primary Outcomes

immunological response

Time Frame: 20 MONTHS

to detect the immunological response in the form of IL-2 and IL-6.

Secondary Outcomes

  • The analgesic duration and requirements in the first twenty-four hours postoperatively(20 MONTHS)
  • The Non-Invasive blood pressure at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.(20 MONTHS)
  • comparing the Visual Analog Score(20 MONTHS)
  • Heart rate at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.(20 MONTHS)

Study Sites (1)

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