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Clinical trial

Effects of Systemic Administration of Dexmedetomidine on Intraocular Pressure During Scheduled Spine Surgeries in a Prone Position. Prospective, Randomized, Double-blinded Study.

ID
Name
DEXIOPSPS
Description
The aim of this study is to examine the effects of intraoperative systemic use of dexmedetomidine on the intraocular pressure (IOP) in patients undergoing spine surgeries in a prone position under general anesthesia.
Trial arms
Trial start
2021-03-20
Estimated PCD
2024-11-01
Trial end
2025-01-01
Status
Recruiting
Treatment
Dexmedetomidine
Administration
Arms:
DEX group
Other names:
Dexmed
Normal Saline
Administration
Arms:
Placebo group
Other names:
Saline
Size
60
Primary endpoint
Intraocular pressure (IOP)
Up to 15 minutes after the end of operation
Eligibility criteria
Inclusion Criteria: * Adult patients undergoing scheduled spine surgery performed in prone position under general anaesthesia Exclusion Criteria: * Patients who refuse to be a part of the study * Patients with previous eye surgery * Preexisting eye disease (e.g glaucoma) * Allergy to the study drug or any drug which is in the trial * Preoperative unstable hemodynamics
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, Randomized, Placebo -controlled, Double-Blinded clinical trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Not aware of the study group', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-01-31

1 organization

1 product

1 indication

Organization
Attikon Hospital
Product
Dexmedetomidine
Indication
Intraocular Pressure