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

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT04908592
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
3
Actual Duration (Months)
33.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Efficacy of Dexamethasone in Attenuation of Postinduction Hypotension in Geriatric Patients Undergoing General Anesthesia: a Randomized Controlled Trial
Actual Study Start Date :
Jun 15, 2021
Actual Primary Completion Date :
Sep 15, 2021
Actual Study Completion Date :
Sep 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: D Group (50 patients)

Drug: Dexamethasone
Patients will receive dexamethasone 8 mg diluted in 100 ml 0.9% normal saline (NS) IVI over 15 min 2 h preoperatively.
Placebo Comparator: C Group (50 patients)

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
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:

  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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain-Shams University Hospitals Cairo Egypt

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
ClinicalTrials.gov Identifier:
NCT04908592
Other Study ID Numbers:
  • FMASU MS 289/ 2021
First Posted:
Jun 1, 2021
Last Update Posted:
Oct 22, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypotension
Dexamethasone

Study Results

No Results Posted as of Oct 22, 2021