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NCT Number: NCT06216210

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

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.

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Key information

Conditions

Opioid Use

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Al-Azhar faculty of medicine

Cairo, 12546, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

opioid-FREE anesthesia.

Drug

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)

opioid-CONTAINING anesthesia.

Drug

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)

Primary outcomes

  1. immunological response

    Time frame: 20 MONTHS

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

Secondary outcomes

  1. The analgesic duration and requirements in the first twenty-four hours postoperatively

    Time frame: 20 MONTHS

    assessing the analgesic duration and requirements in the first twenty-four hours postoperatively

  2. comparing the Visual Analog Score

    Time frame: 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

  3. The Non-Invasive blood pressure at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.

    Time frame: 20 MONTHS

    investigating the changes in blood pressure associated with the two different anesthetic techniques to determine the most suitable approach for bariatric surgery.

  4. Heart rate at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.

    Time frame: 20 MONTHS

    investigating the changes in heart rate associated with the two different anesthetic techniques to determine the most suitable approach for bariatric surgery.

Sponsors and collaborators

Lead sponsor

Zulekha Hospitals

Other

Registry information

Official study 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

Acronym: Mulimi

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2024
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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