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

Primary Purpose

Hypotension

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Dexamethasone

Placebo

About this trial

This is an interventional prevention trial for Hypotension

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Emergency surgeries.
Ischemic heart disease.
Peptic ulcer & active infection.
Psychiatric disorder.
Patients on steroids or serotonin related medications (e.g., selective serotonin reuptake inhibitor).

Sites / Locations

Ain-Shams University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

D Group (50 patients)

C Group (50 patients)

Arm Description

Outcomes

Primary Outcome Measures

The proportion of patients with hypotension (25% decrease below the baseline for mean blood pressure (mmHg).

Secondary Outcome Measures

Full Information

NCT ID

NCT04908592

First Posted

May 27, 2021

Last Updated

October 21, 2021

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT04908592

Brief Title

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

Official Title

Efficacy of Dexamethasone in Attenuation of Postinduction Hypotension in Geriatric Patients Undergoing General Anesthesia: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

June 15, 2021 (Actual)

Primary Completion Date

September 15, 2021 (Actual)

Study Completion Date

September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypotension

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

D Group (50 patients)

Arm Type

Active Comparator

Arm Title

C Group (50 patients)

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

The proportion of patients with hypotension (25% decrease below the baseline for mean blood pressure (mmHg).

Description

The proportion of patients with hypotension (25% decrease below the baseline for mean blood pressure (mmHg).

Time Frame

intraoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: American Society of Anesthesiologists (ASA) Physical Status Class-I and II. Elective surgery under general anesthesia. Exclusion Criteria: Emergency surgeries. Ischemic heart disease. Peptic ulcer & active infection. Psychiatric disorder. Patients on steroids or serotonin related medications (e.g., selective serotonin reuptake inhibitor).

Facility Information:

Facility Name

Ain-Shams University Hospitals

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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