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Effects of Dexmedetomidine on Intraocular Pressure During Scheduled Spine Surgeries

Sponsor
Attikon Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04628663
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
20.4
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, Randomized, Placebo -controlled, Double-Blinded clinical trialProspective, Randomized, Placebo -controlled, Double-Blinded clinical trial
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Not aware of the study group
Primary Purpose:
Prevention
Official Title:
Effects of Systemic Administration of Dexmedetomidine on Intraocular Pressure During Scheduled Spine Surgeries in a Prone Position. Prospective, Randomized, Double-blinded Study.
Actual Study Start Date :
Mar 20, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intraocular pressure (IOP) [Up to 15 minutes after the end of operation]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 2nd Department of Anesthesiology, Attikon University Hospital Athens Attiki Greece 12462

    Sponsors and Collaborators

    • Attikon Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paraskevi Matsota, Prof of Anaesthesiology, Attikon Hospital
    ClinicalTrials.gov Identifier:
    NCT04628663
    Other Study ID Numbers:
    • DEXIOPSPS
    First Posted:
    Nov 13, 2020
    Last Update Posted:
    Feb 16, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dexmedetomidine

    Study Results

    No Results Posted as of Feb 16, 2022