UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020143
Receipt number R000023266
Scientific Title Randomized controlled study for assessing effectiveness of hypercapnia on quality of emergence from general anesthesia in adults
Date of disclosure of the study information 2015/12/10
Last modified on 2018/05/31 05:32:28

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Basic information

Public title

Randomized controlled study for assessing effectiveness of hypercapnia on quality of emergence from general anesthesia in adults

Acronym

hypercapnia and quality of emergence from general anesthesia

Scientific Title

Randomized controlled study for assessing effectiveness of hypercapnia on quality of emergence from general anesthesia in adults

Scientific Title:Acronym

hypercapnia and quality of emergence from general anesthesia

Region

Japan


Condition

Condition

Adult patients undergoing abdominal sugeries under general anesthesia combined with epidural anesthesia

Classification by specialty

Gastrointestinal surgery Hepato-biliary-pancreatic surgery Anesthesiology
Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To test a hypothesis that hypercapnia shortens emergence from general anesthesia and stabilizes cardio-respiratory functions, and to explore interactions between consciousness level and cardio-respiratory functions.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

emergence time from cessation of general anesthetics

Key secondary outcomes

Critical cardio-respiratory events


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

normocapnia: ET-CO2 30-35 mmHg is maintained until emergence from anesthesia.

Interventions/Control_2

hypercapnia: ET-CO2 is gradually reduced from 60-65 mmHg until emergence from anesthesia

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Patients scheduled for invasive arterial blood pressure monitoring
2. Patients scheduled for general anesthesia combined with epidural anesthesia
3. Patients undergoing abdominal surgeries

Key exclusion criteria

1. Patients with ASA (American Society of Anesthesiologists) physical status greater than 3
2. Patients with abnormal upper airway
3. Patients with asthma
4. Patients with post-head and neck surgeries
5. Patients with COPD (%FEV1.0<70%)
6. Patients with tracheostomy
7. Patients with intra-cranial pathologies
8. Patients with hypoxemia at emergence from anesthesia
9. Patients without indication for extubation in the operating room

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shiroh Isono

Organization

Graduate School of Medicine, Chiba University

Division name

Anesthesiology

Zip code


Address

1-8-1 Inohana-cho, Chuo-ku, Chiba

TEL

043-22-7171

Email

shirohisono@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shiroh Isono

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Anesthesiology

Zip code


Address

1-8-1 Inohana-cho, Chuo-ku, Chiba

TEL

043-222-7171

Homepage URL


Email

shirohisono@yahoo.co.jp


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

Japanese grant-in-aid (4390363) from the Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

千葉大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 10 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 11 Month 17 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 12 Month 10 Day

Last modified on

2018 Year 05 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023266


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name