NCT06494969

Brief Summary

The aim of the study to compare the effects of sevoflurane-based anesthesia and propofol-based total intravenous anesthesia on intraocular pressure (IOP) during coronary artery bypass graft surgery (CABG) with cardiopulmonary bypass (CPB). The primary endpoint was to examine the effects of propofol-based total intravenous anesthesia (TIVA) and sevoflurane-based anesthesia methods on IOP during CABG operation. Secondary endpoints included a comparison of hemodynamic variables, blood gas values, intensive care, and hospital stay.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2022

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2022

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
Last Updated

July 10, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

June 28, 2024

Last Update Submit

July 8, 2024

Conditions

Keywords

Intraocular pressurecardiac surgerycoronary artery bypass grafting

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure during coronary artery bypass graft surgery with cardiopulmonary bypass

    Examine the effects of propofol based total intravenous anesthesia and sevoflurane-based anesthesia methods on intraocular pressure during coronary artery bypass graft surgery operation

    Through study completion, an average of 6 months

Study Arms (2)

Group P

Propofol-based total intravenous anesthesia

Device: Intraocular pressure measurement

Group S

Sevoflurane-based anesthesia

Device: Intraocular pressure measurement

Interventions

Intraocular pressures were measured and recorded at 8 predefined time points using a tonometer; before anesthesia induction (T1), 10 min after induction (T2), immediately before the beginning of CPB (T3), 3 minute after the beginning of CPB (T4), 3 minute after cross-clamping (T5), 3min after cross-clamp removal (T6), immediately before the weaning of CPB (T7), and end of the surgery (immediately after skin closure) (T8).

Group PGroup S

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective coronary artery bypass grafting surgery with cardiopulmonary bypass (CPB) were included.

You may qualify if:

  • Patients undergoing elective coronary artery bypass grafting surgery with cardiopulmonary bypass (CPB)

You may not qualify if:

  • history of cardiac surgery
  • diabetic retinopathy
  • cataract
  • uncontrolled hypertension
  • chronic kidney disease
  • glaucoma
  • previous eye surgery
  • previous neurological disease
  • allergy to propofol or sevoflurane
  • baseline intraocular pressure (IOP) greater than 30 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Science University, Antalya Training and Research Hospital

Antalya, Muratpasa, 071**, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Tonometry, Ocular

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Ali Sait Kavaklı

    Associate professor

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2024

First Posted

July 10, 2024

Study Start

September 1, 2021

Primary Completion

January 3, 2022

Study Completion

January 28, 2022

Last Updated

July 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations