Immunomodulatory Effects of Dexmedetomidine Infusion
1 other identifier
interventional
100
1 country
1
Brief Summary
Anesthetic management may affect both immunostimulatory and immunosuppressive mechanisms directly by modulating immune cell function or indirectly by attenuating the stress response, Thus, the choice of anesthetic technique may affect clinical outcomes by perturbing the balance between pro- and anti-inflammatory responses,anesthetics favoring this delicate balance are thus desirable as their use may reduce postoperative complications and mortality
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2021
CompletedFirst Posted
Study publicly available on registry
June 11, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedJune 1, 2022
May 1, 2022
4 months
June 7, 2021
May 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
immune-modulatory effects
serum concentrations of C-reactive protein (CRP) level ,The pro-inflammatory cytokines interleukin (IL)-1β, and IL-6 and anti-inflammatory cytokines IL-10 will be measured at four times: T0 (before anesthesia), T1 (1 h after surgery), T2 (24 h after surgery) and T4 (72 h after surgery
three days after surgery
Study Arms (2)
Dexmedetomidine group
ACTIVE COMPARATORpatients will receive a loading dose of IV Dexmedetomidine1μg/kg slowly just before induction of anesthesia, then Dexmedetomidine infusion started at a rate of 0.5μg/kg/h.
Control group
PLACEBO COMPARATORpatients will receive an equal volume of 0.9% sodium chloride (both the loading, and the infusion
Interventions
patients will receive a loading dose of IV Dexmedetomidine1μg/kg slowly just before induction of anesthesia, then Dexmedetomidine infusion started at a rate of 0.5μg/kg/h.
patients will receive an equal volume of 0.9% sodium chloride (both the loading, and the infusion
Eligibility Criteria
You may qualify if:
- scheduled for elective laparoscopic major abdominal surgeries;
- ASA class II-III
You may not qualify if:
- \- 1- Patients with severe infection or diseases in respiratory system 2- Patients with severe arrhythmia or bradycardia 3- Patients with severe diseases in liver, kidney, endocrine or immune system. 4- Patients with history of uncontrolled hypertension, A-V conduction block. 5- Patients who had administrated the α-adrenergic agonists or β-receptor antagonist.
- Patients who received the chemotherapy, radiotherapy, or immunotherapy within one month before operation 7- Patients who had feverbefore operation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rehab Abd Elraof Abd Elaziz
Alexandria, 000000, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
rehab A. Abd Elaziz, Ass.Prof.
Alexandria University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant Professor of Anesthesia
Study Record Dates
First Submitted
June 7, 2021
First Posted
June 11, 2021
Study Start
January 1, 2022
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
June 1, 2022
Record last verified: 2022-05