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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908592
• Other study ID #: FMASU MS 289/ 2021
• Status: Completed
• Phase: Phase 4
• Start date: June 15, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: October 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hypotension

Intervention

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

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

Locations

Country	Name	City	State
Egypt	Ain-Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with hypotension (25% decrease below the baseline for mean blood pressure (mmHg).	The proportion of patients with hypotension (25% decrease below the baseline for mean blood pressure (mmHg).	intraoperative