NCT01531491

Brief Summary

Hypercapnia derives increase of cerebral blood flow and cardiac output. It means that the rate of propofol elimination from the brain and the blood will be increased and the patient will awake more quickly. There has been no study about the effects of hypercapnia. The investigators will evaluate hypercapnia's effects on the recovery time from propofol anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

1.4 years

First QC Date

February 6, 2012

Last Update Submit

February 12, 2015

Conditions

Anesthesia, IntravenousAnesthesia Recovery Period

Keywords

EmergenceHypercapniaHypocapniaPropofol

Outcome Measures

Primary Outcomes (1)

  • Time to open eyes under investigator's command

    After stopping propofol infusion, every 30 seconds, the investigator (caregiver) will command the patient, "Open your eyes". When the patient opens eyes, the time will be recorded. The patients will be followed for an expected average of 10 minutes.

    From cessation of propofol infusion to patient's eye opening (seconds)

Secondary Outcomes (4)

  • Time to breath spontaneously

    From cessation of propofol infusion to patient's spontaneous breathing (sec)

  • Change of bispectral index (BIS)

    From the cessation of propofol infusion to extubation, BIS and time (seconds) will be recorded.

  • Time to open mouth under investigator's command

    From cessation of propofol infusion to patient's mouth opening (seconds)

  • Time to extubation

    From cessation of propofol infusion to extubation (sec)

Study Arms (2)

Hypercapnia group

EXPERIMENTAL

Respiratory rate will be 10/min and the rebreathing tube will be connected between the y-piece of corrugated tube and the tracheal tube to maintain the partial pressure of the end-tidal carbon dioxide at around 50 mmHg during emergence after propofol anesthesia.

Procedure: Rebreathing tube

Hypocapnia group

EXPERIMENTAL

No rebreathing tube (Nothing) will be connected. Respiratory rate will be 10/min and the tidal volume will be modulated to maintain the partial pressure of the end-tidal carbon dioxide at around 30 mmHg during emergence after propofol anesthesia.

Procedure: No rebreathing tube (Nothing)

Interventions

Rebreathing tubePROCEDURE

750 ml rebreathing tube will be connected between the corrugated tube and the tracheal tube of a patient. Target partial pressure of the end-tidal carbon dioxide is 50 mmHg.

Hypercapnia group
No rebreathing tube (Nothing)PROCEDURE

750 ml rebreathing tube will not be connected between the corrugated tube and the tracheal tube of a patient. Target partial pressure of the end-tidal carbon dioxide is 30 mmHg.

Hypocapnia group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists physical status (ASA PS) I-II
  • Age 20 - 60 years male and female
  • Elective schedule with minor surgery under general anesthesia

You may not qualify if:

  • Body mass index (BMI) \>= 30 (kg/m2)
  • Patient with pulmonary, cardiac, endocrinal, neuromuscular and neurological diseases or past history
  • Patient with medication affecting on this study
  • Patient with general anesthesia history within one month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital

Goyang, Kyunggido, 140-773, South Korea

Location

MeSH Terms

Conditions

HypercapniaHypocapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Junyong In, M.D.

    Department of anesthesiology and pain medicine, Dongguk University Ilsan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 13, 2012

Study Start

January 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 16, 2015

Record last verified: 2015-02

Locations

KR(1)