NCT02151305

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2010

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

August 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
Last Updated

May 30, 2014

Status Verified

May 1, 2014

Enrollment Period

1.7 years

First QC Date

May 27, 2014

Last Update Submit

May 27, 2014

Conditions

CataractRetina DetachmentPterygiumKeratitisVitreous Hemorrhage

Outcome Measures

Primary Outcomes (4)

  • Clotting time of ROTEM

    10 minutes before the induction of anesthesia, 1 h after finishing anesthesia

  • Clot firmness time of ROTEM

    10 minutes before the induction of anesthesia, 1 h after finishing anesthesia

  • Alpha angle of ROTEM

    10 minutes before the induction of anesthesia, 1 h after finishing anesthesia

  • Maximum clot firmness of ROTEM

    10 minutes before the induction of anesthesia, 1 h after finishing anesthesia

Secondary Outcomes (6)

  • Hemoglobin

    10 minutes before the induction of anesthesia

  • Hematocrit

    10 minutes before the induction of anesthesia

  • Platelet count

    10 minutes before the induction of anesthesia

  • International normalized ratio of prothrombin time

    10 minutes before the induction of anesthesia

  • Activated partial thromboplastin time

    10 minutes before the induction of anesthesia

  • +1 more secondary outcomes

Study Arms (2)

Total intravenous anesthesia group

EXPERIMENTAL

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

Drug: Propofol, remifentanil

Inhalation anesthesia group

EXPERIMENTAL

This group received sevoflurane for the maintenance of general anesthesia.

Drug: Sevoflurane

Interventions

Propofol, remifentanilDRUG
Total intravenous anesthesia group
SevofluraneDRUG
Inhalation anesthesia group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

CataractRetinal DetachmentPterygiumKeratitisVitreous Hemorrhage

Interventions

PropofolRemifentanilSevoflurane

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRetinal DiseasesConjunctival DiseasesCorneal DiseasesEye HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pf

Study Record Dates

First Submitted

May 27, 2014

First Posted

May 30, 2014

Study Start

August 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

May 30, 2014

Record last verified: 2014-05

Locations

KR(1)