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CompletedNCT04908592Updated Oct 22, 2021

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

A Phase 4 interventional study of Dexamethasone and Placebo in Hypotension, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2021-10-22.

Sponsored by Ain Shams University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
60 Years and older
Sex
All
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Study 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.
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Conditions studied

  • Hypotension

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In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 100 is above the median of 80 across 675 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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).
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    D Group (50 patients)

    Drug: Dexamethasone

  • Placebo comparator
    C Group (50 patients)

    Other: Placebo

Interventions

  • DrugDexamethasone

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

  • OtherPlacebo

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

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What researchers measure

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).

    Time frame: intraoperative

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Study locations

1 site
  • Ain-Shams University Hospitals
    Cairo, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04908592
Lead sponsor
Ain Shams University
Responsible party
Dr.Ibrahim Mamdouh Esmat (Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt., Ain Shams University) — Principal investigator
First posted
Jun 1, 2021
Start date
Jun 15, 2021
Primary completion
Sep 15, 2021
Completion
Sep 15, 2021
Last update
Oct 22, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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