Immunomodulatory Effects of Dexmedetomidine Infusion

NCT ID: NCT04923737

Last Updated: 2022-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Major Abdominal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexmedetomidine group

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.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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.

Control group

patients will receive an equal volume of 0.9% sodium chloride (both the loading, and the infusion

Group Type PLACEBO_COMPARATOR

0.9% sodium chloride

Intervention Type DRUG

patients will receive an equal volume of 0.9% sodium chloride (both the loading, and the infusion

Interventions

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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.

Intervention Type DRUG

0.9% sodium chloride

patients will receive an equal volume of 0.9% sodium chloride (both the loading, and the infusion

Intervention Type DRUG

Eligibility Criteria

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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 α-adrenergic agonists or β-receptor antagonist.

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

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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rehab zayed

Assisstant Professor of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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rehab A. Abd Elaziz, Ass.Prof.

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

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Rehab Abd Elraof Abd Elaziz

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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rehab A. Abd Elaziz, Ass. Prof.

Role: CONTACT

01001073703 ext. 020

rehab A. Abd Elaziz, Ass.Prof.

Role: CONTACT

01001073703 ext. 020

Facility Contacts

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Rehab A. Abd Elaziz, Ass. Prof.

Role: primary

01001073703 ext. 020

Other Identifiers

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0304767

Identifier Type: -

Identifier Source: org_study_id

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