Effects of Dexmedetomidine on Intraocular Pressure During Scheduled Spine Surgeries

NCT04628663 | Recruiting

• 1 other identifier: DEXIOPSPS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure (IOP)

  The measurement of IOP will be conducted in both eyes with Icare PRO tonometer by an ophthalmologist at predefined time points

  Up to 15 minutes after the end of operation

Study Arms (2)

DEX group

ACTIVE COMPARATOR

Dexmedetomidine given at a bolus dose of 1,0 μg/kg 10min before induction of anesthesia and then after as a continuous infusion 0,4-0,8 μg/kg/h until the end of the surgery.

Drug: Dexmedetomidine

Placebo group

PLACEBO COMPARATOR

Normal saline given as a bolus dose 10min before induction of anesthesia and then after as a continuous infusion until the end of the surgery.

Other: Normal Saline

Interventions

Dexmedetomidine DRUG

Administration

Also known as: Dexmed

DEX group

Normal Saline OTHER

Administration

Also known as: Saline

Placebo group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing scheduled spine surgery performed in prone position under general anaesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

2nd Department of Anesthesiology, Attikon University Hospital

Athens, Attica, 12462, Greece

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Paraskevi Matsota, Prof

  2nd Department of Anesthesiology, Attikon University Hospital

  STUDY CHAIR

Central Study Contacts

Paraskevi Matsota, Prof

CONTACT

6945544563; matsota@yahoo.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Not aware of the study group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof of Anaesthesiology

Model Details: Prospective, Randomized, Placebo -controlled, Double-Blinded clinical trial

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 13, 2020
• Study Start: March 20, 2021
• Primary Completion: November 1, 2025
• Study Completion: May 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)