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

NCT03664037 | Completed Phase 4

• 1 other identifier: R 46 / 2018
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Outcome Measures

Primary Outcomes (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.

  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.

  The first 20 minutes after induction of SA before start of surgical procedure.

Study Arms (2)

D group, (n=55)

ACTIVE COMPARATOR

Drug: Dexamethasone phosphate

C group, (n=55)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dexamethasone phosphate DRUG

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

D group, (n=55)

Placebo DRUG

each patient received 100 mL 0.9% NS IVI over 15 min (Placebo) 2 hours preoperatively

C group, (n=55)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ibrahim Mamdouh Esmat

Heliopolis, Cairo Governorate, 11361, Egypt

Location

Related Publications (1)

• Ashoor TM, Hussien NS, Anis SG, Esmat IM. Dexamethasone blunts postspinal hypotension in geriatric patients undergoing orthopedic surgery: a double blind, placebo-controlled study. BMC Anesthesiol. 2021 Jan 11;21(1):11. doi: 10.1186/s12871-021-01232-w.

  PMID: 33430772 DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 10, 2018
• Study Start: March 1, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

EG (1)