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Efficacy of Dexamethasone in Attenuation of Postinduction Hypotension in Geriatric Patients Undergoing General Anesthesia

NCT ID: NCT04908592

Last Updated: 2021-10-22

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2021-09-15

Brief Summary

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* Geriatric patients who undergo general anesthesia experience post induction hypotension which is treated with intravenous fluids and ephedrine. The main cause of post-induction hypotension is the decrease in the sympathetic outflow causing arterial vasodilatation, a decrease in venous return and consequently the activation of the Bezold Jarish reflex (BJR) that elicits a triad of bradycardia, vasodilatation and further hypotension. BJR is elicited by activation of 5-HT3 receptors within the intracardiac vagal nerve endings.
* Glucocorticoids in general inhibit 5-HT3 expression and dexamethasone was found to decrease the level of 5-HT3 in the cerebral cortex and hippocampus in developing rats. So, the research team hypothesizes that dexamethasone can attenuate the postinduction hypotension in geriatric patients undergoing general anesthesia if administered preoperatively.

Detailed Description

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Conditions

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Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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D Group (50 patients)

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Patients will receive dexamethasone 8 mg diluted in 100 ml 0.9% normal saline (NS) IVI over 15 min 2 h preoperatively.

C Group (50 patients)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Patients will receive 100 ml 0.9% normal saline (NS) IVI over 15 min 2 h preoperatively.

Interventions

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Dexamethasone

Patients will receive dexamethasone 8 mg diluted in 100 ml 0.9% normal saline (NS) IVI over 15 min 2 h preoperatively.

Intervention Type DRUG

Placebo

Patients will receive 100 ml 0.9% normal saline (NS) IVI over 15 min 2 h preoperatively.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. American Society of Anesthesiologists (ASA) Physical Status Class-I and II.
2. Elective surgery under general anesthesia.

Exclusion Criteria

1. Emergency surgeries.
2. Ischemic heart disease.
3. Peptic ulcer \& active infection.
4. Psychiatric disorder.
5. Patients on steroids or serotonin related medications (e.g., selective serotonin reuptake inhibitor).
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Dr.Ibrahim Mamdouh Esmat

Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain-Shams University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU MS 289/ 2021

Identifier Type: -

Identifier Source: org_study_id