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

NCT ID: NCT06216210

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-22
• Study Completion Date: 2023-10-04

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.

Conditions

Opioid Use

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group (A)

Opioid-free anesthesia group

opioid-FREE anesthesia.

Intervention Type: 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.,

Group (B)

Opioid-containing anesthesia group.

opioid-CONTAINING anesthesia.

Intervention Type: 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.

Interventions

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.,

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

GROUP (A); GROUP (B)

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zulekha Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

SAMEH HA SEYAM, MD

Role: STUDY_CHAIR

assistant professor of anesthesiology, intensive care, and pain management, A-Azhar university

Locations

Al-Azhar faculty of medicine

Cairo, , Egypt

Countries

Egypt

Other Identifiers

T.G.H.45/275

Identifier Type: -

Identifier Source: org_study_id