Effects of Dexmedetomidine on Intraocular Pressure During Scheduled Spine Surgeries

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intraocular Pressure
• Intervention / Treatment: Drug: Dexmedetomidine; Other: Normal Saline

Detailed Description

The study is a Prospective, Randomized, Placebo -controlled, Double-Blinded clinical trial Adult patients with an ASA physical status of class I, II or III who are scheduled for an elective spine surgery in prone position under general anesthesia will be included in the study.

The patients will be randomized with closed envelope manner into two groups: the group of dexmedetomidine and the group of normal saline.

In the dexmedetomidine group (DEX group), bolus dose 1,0 μg/kg of dexmedetomidine will be administered in 10min before induction to anesthesia and 0,4-0,8 μg/kg/h of dexmedetomidine will be infused continuously until the end of the surgery.

In the saline group (placebo group), the same volume of saline will be administered in an identical way.

All study medication will be prepared by an independent anesthesiologist who is not associated in the study (who will hold the randomization codes until the end of the study).

All patients will receive the same type of anaesthesia (TIVA with propofol) and postoperative analgesia including paracetamol 1gr iv (4 times/day) and continuous wound infiltration with ropivacaine 0.2% 5ml/h for 48 postoperative hours.

Basic monitoring for the study includes:

ECG, Invasive and noninvasive blood pressure, Heart Rate, EtCO2, SpO2, Cardiac Output (CO), Stroke Volume (SV), Stroke Volume Variation (SVV), Patient State index (PSi), IOP, Urine output.

Measurements

The measurement of IOP will be conducted in both eyes with Icare PRO tonometer by an ophthalmologist who will not know in which group the patient is in the below predefined time points:

• T1: before administration of the study drug
• T2: after administration of the bolus dose of the study drug
• T3: after tracheal intubation
• T4: just before prone position
• T5: just after prone position
• T6: 30min after T5
• T7: 60min after T6
• T8: 120min after T7
• T9: 180min after T8
• T10: at the end of the surgery and the patient in supine position At the time of each tonometer reading the following data set is collected: MAP, heart rate, EtCO2, SpO2, CO, SV, SVV, urine output, Psi, IOP. Moreover OPP will be calculated as MAP minus IOP.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paraskevi Matsota, Prof; Phone Number: 6945544563; Email: matsota@yahoo.gr

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 12462
      • Recruiting
      • 2nd Department of Anesthesiology, Attikon University Hospital
      • Contact: Paraskevi Matsota, MD, PhD; Phone Number: +30210583100; Email: matsota@yahoo.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DEX group; 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; Administration; Other Names: Dexmed
Placebo Comparator: Placebo group; 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; Administration; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Attikon Hospital
• Investigators: Study Chair: Paraskevi Matsota, Prof, 2nd Department of Anesthesiology, Attikon University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2021
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: DEXIOPSPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No