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Dexamethasone Blunts the Hypotensive Effect of Spinal Anesthesia in Geriatric Patients Undergoing Lower Limb Orthopedic Surgeries

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ClinicalTrials.gov Identifier: NCT03664037
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Dr.Ibrahim Mamdouh Esmat, Ain Shams University

Brief Summary:
Based on the data that DEX increases the TPR and may decrease the expression of serotonin the investigator conducted this study to test the hypothesis that the prophylactic intravenous infusion (IVI) of DEX can attenuate the hypotensive effect of spinal anesthesia in elderly population.

Condition or disease Intervention/treatment Phase
Hypotension Drug: Dexamethasone phosphate Drug: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Dexamethasone Blunts the Hypotensive Effect of Spinal Anesthesia in Geriatric Patients Undergoing Lower Limb Orthopedic Surgeries: a Double Blind, Placebo-controlled Study
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018


Arm Intervention/treatment
Active Comparator: D group, (n=55) Drug: Dexamethasone phosphate
each patient received 8 mg of intravenous DEX diluted in 100 ml 0.9% sodium chloride (normal saline [NS]) intravenous infusion (IVI) over 15 min 2 hours preoperatively

Placebo Comparator: C group, (n=55) Drug: Placebo
each patient received 100 mL 0.9% NS IVI over 15 min (Placebo) 2 hours preoperatively




Primary Outcome Measures :
  1. proportions of patients with hypotension defined as a MAP at least 25% less than the basal value at any time during the first 20 min after induction of SA before start of surgical procedure. [ Time Frame: The first 20 minutes after induction of SA before start of surgical procedure. ]
    proportions of patients with hypotension defined as a MAP at least 25% less than the basal value at any time during the first 20 min after induction of SA before start of surgical procedure.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 110 patients aged 60 years or older
  • of the American Society of Anesthesiologists (ASA) physical status I, II or III
  • undergoing lower limb orthopedic surgeries.
  • A written informed consent was obtained from all patients to participate in the study.

Exclusion Criteria:

  • Patients with contraindication to SA (e.g.- coagulopathy,
  • thrombocytopenia,
  • allergy to local anesthetic agent)
  • and those on steroid or serotonin related medications (e.g. selective serotonin reuptake inhibitor) were excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664037


Locations
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Egypt
Ibrahim Mamdouh Esmat
Heliopolis, Cairo, Egypt, 11361
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Dr.Ibrahim Mamdouh Esmat, Assistant Professor, M.D., Department of Anesthesia and Intensive Care, Ain- shams University, Egypt., Ain Shams University
ClinicalTrials.gov Identifier: NCT03664037     History of Changes
Other Study ID Numbers: R 46 / 2018
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antihypertensive Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action