NCT02149745

Brief Summary

The purpose of this study is to find if we can shorten the recovery time by calling the patient's name during anesthesia reversal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 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

First Submitted

Initial submission to the registry

May 8, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

June 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1.4 years

First QC Date

May 8, 2014

Last Update Submit

June 1, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference in recovery time between the two groups

    difference in recovery time (eye opening time, extubation time) after stopping injection of anesthetics, and the time when the patient's bispectral index value displayed on the monitor is above 60

    1 min,2 min,3 min, 4min, 5min, 6min, 7min, 8min, 9min, 10min after stopping injection of anesthetics

Study Arms (2)

Calling the patient's name

EXPERIMENTAL

The anesthesiologist tries to recover the patient's consciousness by calling the patient's name

Procedure: Calling the patient's name

Not calling the patient's name

EXPERIMENTAL

The anesthesiologist tries to recover the patient's consciousness by giving verbal stimulus other than the patient's name

Procedure: Not calling the patient's name

Interventions

calling the patient's name during anesthesia reversal

Calling the patient's name

giving verbal stimulus other than the patient's name during anesthesia reversal

Not calling the patient's name

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient aged between 20-70
  • patient receiving breast cancer surgery under general anesthesia with total intravenous anesthesia using remifentanil and propofol, and intubated with LMA

You may not qualify if:

  • refusal of consent
  • patients taking CNS stimulants
  • general anesthesia with other agents than propofol and remifentanil
  • intubated with other equipments than LMA
  • chronic alcoholic patient
  • patients with convulsive disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

May 8, 2014

First Posted

May 29, 2014

Study Start

June 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

June 2, 2017

Record last verified: 2017-06

Locations