Clinical trial

Dexamethasone Blunts the Hypotensive Effect of Spinal Anesthesia in Geriatric Patients Undergoing Lower Limb Orthopedic Surgeries: a Double Blind, Placebo-controlled Study

Name

R 46 / 2018

Description

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.

Trial arms

Trial start

2018-03-01

Estimated PCD

2018-08-31

Trial end

2018-08-31

Status

Completed

Phase

Early phase I

Treatment

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

Arms:

D group, (n=55)

Placebo

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

Arms:

C group, (n=55)

Size

110

Primary endpoint

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.

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 110, 'type': 'ACTUAL'}}

Updated at

2023-07-21

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug