Clinical trial
Assessing the Impact of Opioid-Free Anesthesia Using the Modified Mulimix Technique on Plasma Interleukin-2 and Interleukin-6 Levels in Bariatric Surgery Patients
Name
T.G.H.45/275
Description
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.
Trial arms
Trial start
2022-04-22
Estimated PCD
2023-10-04
Trial end
2023-10-04
Status
Completed
Treatment
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.,
Arms:
Group (A)
Other names:
GROUP (A)
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.
Arms:
Group (B)
Other names:
GROUP (B)
Size
60
Primary endpoint
immunological response
20 MONTHS
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-01-22
1 organization
Organization
Zulekha Hospitals