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

NCT04908592 | Completed Phase 4

• 1 other identifier: FMASU MS 289/ 2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

D Group (50 patients)

ACTIVE COMPARATOR

Drug: Dexamethasone

C Group (50 patients)

PLACEBO COMPARATOR

Other: Placebo

Interventions

Dexamethasone DRUG

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

D Group (50 patients)

Placebo OTHER

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

C Group (50 patients)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Hypotension

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 1, 2021
• Study Start: June 15, 2021
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)