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

NCT06216210 | Completed

• 1 other identifier: T.G.H.45/275
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

• immunological response

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

  20 MONTHS

Secondary Outcomes (4)

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

  20 MONTHS

• comparing the Visual Analog Score

  20 MONTHS

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

  20 MONTHS

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

  20 MONTHS

Study Arms (2)

Group (A)

Opioid-free anesthesia group

Drug: opioid-FREE anesthesia.

Group (B)

Opioid-containing anesthesia group.

Drug: opioid-CONTAINING anesthesia.

Interventions

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.,

Also known as: GROUP (A)

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.

Also known as: GROUP (B)

Group (B)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A study was conducted on a sample of 60 patients, comprising individuals of both genders aged between 20 and 50 years.

You may qualify if:

• 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.

You may not qualify if:

• patients who declined participation in the trial
• pregnant women
• patients who encountered challenges in communication that could potentially impede a dependable postoperative evaluation

Sponsors & Collaborators

• Zulekha Hospitals: lead

Study Sites (1)

Al-Azhar faculty of medicine

Cairo, 12546, Egypt

Location

Study Officials

• SAMEH HA SEYAM, MD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 22, 2024
• Study Start: April 22, 2022
• Primary Completion: October 4, 2023
• Study Completion: October 4, 2023
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

EG (1)