Immunomodulatory Effects of Dexmedetomidine Infusion

Major Abdominal Surgery Clinical Trial

Official title:

Immunomodulatory Effects of Dexmedetomidine Infusion After Laparoscopic Major Abdominal Surgeries: Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04923737
• Other study ID #: 0304767
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: May 2022

Study information

• Verified date: May 2022
• Source: Alexandria University
• Contact: rehab A. Abd Elaziz, Ass. Prof.
• Phone: 01001073703
• Email: trcium2002[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

• scheduled for elective laparoscopic major abdominal surgeries;

• ASA class II-III

Exclusion Criteria:

• 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 a-adrenergic agonists or ß-receptor antagonist.

6- Patients who received the chemotherapy, radiotherapy, or immunotherapy within one month before operation 7- Patients who had feverbefore operation

Related Conditions & MeSH terms

• Major Abdominal Surgery

Intervention

Drug:
• Dexmedetomidine
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.
• 0.9% sodium chloride
patients will receive an equal volume of 0.9% sodium chloride (both the loading, and the infusion

Locations

Country	Name	City	State
Egypt	Rehab Abd Elraof Abd Elaziz	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immune-modulatory effects	serum concentrations of C-reactive protein (CRP) level ,The pro-inflammatory cytokines interleukin (IL)-1ß, 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