NCT02212340

Brief Summary

Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely used, and there are many clinical trials comparing these on various aspects of anesthesia. However, there have not been studies comparing the quality of recovery from the different methods of general anesthesia in vitrectomy. In this study, the investigators compare the functional recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40 questionnaire in vitrectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

1.5 years

First QC Date

August 6, 2014

Last Update Submit

September 26, 2016

Conditions

Keywords

propofoldesfluranequality of recoveryvitrectomy

Outcome Measures

Primary Outcomes (1)

  • QoR-40 score

    at 6 hours later after surgery

Study Arms (2)

TIVA group

EXPERIMENTAL

Anesthesia is maintained with fresofol and remifentanil

Drug: fresofol and remifentanil

Des group

ACTIVE COMPARATOR

Anesthesia is maintained with desflurane and remifentanil

Drug: desflurane and remifentanil

Interventions

Anesthesia is maintained with fresofol and remifentanil in TIVA group or with desflurane and remifentanil in Des group according to randomly allocated group.

TIVA group

Anesthesia is maintained with fresofol and remifentanil in TIVA group or with desflurane and remifentanil in Des group according to randomly allocated group.

Des group

Eligibility Criteria

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

You may qualify if:

  • Patients (20-80 years old) scheduled for vitrectomy surgery undergoing general anesthesia.
  • ASA 1-3

You may not qualify if:

  • Patients with allergy to anesthetic agents
  • Anticipated difficult airway
  • BMI \> 30 kg/m2
  • Chronic obstructive pulmonary disease
  • Heart failure 6. Unstable angina

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital, Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

PropofolRemifentanilDesflurane

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEthyl EthersEthersMethyl EthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2014

First Posted

August 8, 2014

Study Start

July 1, 2014

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations