Opioid UseMulimiNCT06216210
Assessing the Impact of Opioid-Free Anesthesia Using the Modified Mulimix Technique.
An observational study of Opioid Use, run by Zulekha Hospitals at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use
- What is being tested?
- opioid-FREE anesthesia. and opioid-CONTAINING anesthesia.
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Apr 2022to 4 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A study was conducted on a sample of 60 patients, comprising individuals of both genders aged between 20 and 50 years.
Who may be able to join
- 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.
Who cannot join
- patients who declined participation in the trial
- pregnant women
- patients who encountered challenges in communication that could potentially impede a dependable postoperative evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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
- Being tested
- opioid-FREE anesthesia., opioid-CONTAINING anesthesia.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid-FREE anesthesia.Drug
Also called GROUP (A)
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.,
opioid-CONTAINING anesthesia.Drug
Also called GROUP (B)
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.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Opioid-free anesthesia group Receives: Drug: opioid-FREE anesthesia. | |
| Group (B) | Opioid-containing anesthesia group. Receives: Drug: opioid-CONTAINING anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunological response
to detect the immunological response in the form of IL-2 and IL-6.
Measured: 20 MONTHS
Secondary outcomes (4)
The analgesic duration and requirements in the first twenty-four hours postoperatively
assessing the analgesic duration and requirements in the first twenty-four hours postoperatively
Measured: 20 MONTHS
comparing the Visual Analog Score
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
Measured: 20 MONTHS
The Non-Invasive blood pressure at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.
investigating the changes in blood pressure associated with the two different anesthetic techniques to determine the most suitable approach for bariatric surgery.
Measured: 20 MONTHS
Heart rate at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.
investigating the changes in heart rate associated with the two different anesthetic techniques to determine the most suitable approach for bariatric surgery.
Measured: 20 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start22 Apr 2022
- Primary completion4 Oct 2023
- Study completion4 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zulekha Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SAMEH HA SEYAM, MD, Study chair, assistant professor of anesthesiology, intensive care, and pain management, A-Azhar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216210
- Sponsor's protocol ID
- T.G.H.45/275
- Acronym
- Mulimi
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06216210
- Acronym / sponsor ID
- Mulimi / T.G.H.45/275
- Conditions
- Opioid Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zulekha HospitalsUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 4 Oct 2023 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | – | Drug: opioid-FREE anesthesia.Opioid-free anesthesia group |
| Group (B) | – | Drug: opioid-CONTAINING anesthesia.Opioid-containing anesthesia group. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A study was conducted on a sample of 60 patients, comprising individuals of both genders aged between 20 and 50 years.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- patients who declined participation in the trial
- pregnant women
- patients who encountered challenges in communication that could potentially impede a dependable postoperative evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| opioid-FREE anesthesia.Also: GROUP (A)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., | Drug | Group (A) |
| opioid-CONTAINING anesthesia.Also: GROUP (B)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. | Drug | Group (B) |
Primary outcome
immunological response
Time frame: 20 MONTHS
to detect the immunological response in the form of IL-2 and IL-6.
4 secondary outcomes
The analgesic duration and requirements in the first twenty-four hours postoperatively
Time frame: 20 MONTHS
comparing the Visual Analog Score
Time frame: 20 MONTHS
The Non-Invasive blood pressure at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.
Time frame: 20 MONTHS
Heart rate at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.
Time frame: 20 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SAMEH HA SEYAM, MD study chair
assistant professor of anesthesiology, intensive care, and pain management, A-Azhar university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use, run by Zulekha Hospitals at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immunological response (time frame: 20 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.