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Different Hemostasis According to the Anesthetic Agents

Primary Purpose

Cataract, Retina Detachment, Pterygium

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Propofol, remifentanil
Sevoflurane
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cataract

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patient scheduled for ophthalmic surgery under general anesthesia
  • American Society of Anesthesiologist physical status I or II

Exclusion Criteria:

  • hematologic disorder
  • severe anemia
  • liver disease
  • kidney disease
  • taking a medication interfering with hemostasis

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Total intravenous anesthesia group

Inhalation anesthesia group

Arm Description

This group received propofol and remifentanil for the maintenance of general anesthesia.

This group received sevoflurane for the maintenance of general anesthesia.

Outcomes

Primary Outcome Measures

Clotting time of ROTEM
Clot firmness time of ROTEM
Alpha angle of ROTEM
Maximum clot firmness of ROTEM

Secondary Outcome Measures

Hemoglobin
Hematocrit
Platelet count
International normalized ratio of prothrombin time
Activated partial thromboplastin time
Fibrinogen

Full Information

First Posted
May 27, 2014
Last Updated
May 27, 2014
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02151305
Brief Title
Different Hemostasis According to the Anesthetic Agents
Official Title
The Influence of Propofol and Sevoflurane on Hemostasis During Ophthalmic Surgery: Rotational Thromboelastographic Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

5. Study Description

Brief Summary
We investigated the hemostatic differences according to the main anesthetic agents by analyzing rotational thromboelastometry (ROTEM) under the hypothesis that propofol-based anesthesia would impair postoperative coagulability more than the sevoflurane-based anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Retina Detachment, Pterygium, Keratitis, Vitreous Hemorrhage

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total intravenous anesthesia group
Arm Type
Experimental
Arm Description
This group received propofol and remifentanil for the maintenance of general anesthesia.
Arm Title
Inhalation anesthesia group
Arm Type
Experimental
Arm Description
This group received sevoflurane for the maintenance of general anesthesia.
Intervention Type
Drug
Intervention Name(s)
Propofol, remifentanil
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Primary Outcome Measure Information:
Title
Clotting time of ROTEM
Time Frame
10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
Title
Clot firmness time of ROTEM
Time Frame
10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
Title
Alpha angle of ROTEM
Time Frame
10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
Title
Maximum clot firmness of ROTEM
Time Frame
10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
Secondary Outcome Measure Information:
Title
Hemoglobin
Time Frame
10 minutes before the induction of anesthesia
Title
Hematocrit
Time Frame
10 minutes before the induction of anesthesia
Title
Platelet count
Time Frame
10 minutes before the induction of anesthesia
Title
International normalized ratio of prothrombin time
Time Frame
10 minutes before the induction of anesthesia
Title
Activated partial thromboplastin time
Time Frame
10 minutes before the induction of anesthesia
Title
Fibrinogen
Time Frame
10 minutes before the induction of anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patient scheduled for ophthalmic surgery under general anesthesia American Society of Anesthesiologist physical status I or II Exclusion Criteria: hematologic disorder severe anemia liver disease kidney disease taking a medication interfering with hemostasis
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Different Hemostasis According to the Anesthetic Agents

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