Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol

Anesthesia Recovery Period Clinical Trial

Official title:

Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531491
• Other study ID #: J In 2011-3
• Status: Completed
• Phase: N/A
• First received: February 6, 2012
• Last updated: February 12, 2015
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: February 2015
• Source: DongGuk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardKorea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Anesthesia Recovery Period
• Anesthesia, Intravenous
• Hypercapnia

Intervention

Procedure:
• Rebreathing tube
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.
• No rebreathing tube (Nothing)
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.

Locations

Country	Name	City	State
Korea, Republic of	Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital	Goyang	Kyunggido

Sponsors (1)

Lead Sponsor	Collaborator
DongGuk University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Time to breath spontaneously	The time from cessation of propofol infusion to patient's spontaneous breaths will be recorded. The patients will be followed for an expected average of 10 minutes.	From cessation of propofol infusion to patient's spontaneous breathing (sec)	No
Secondary	Change of bispectral index (BIS)	After stopping propofol infusion, the BIS and time (seconds) will be recorded and reviewed. These will be recorded for an expected average of 15 minutes.	From the cessation of propofol infusion to extubation, BIS and time (seconds) will be recorded.	No
Secondary	Time to open mouth under investigator's command	After the patient opens the eyes, every 10 seconds, the investigator command the patient, "Open your mouth.". When the patient opens mouth, the time will be recorded. The patients will be followed for an expected average of 12 minutes.	From cessation of propofol infusion to patient's mouth opening (seconds)	No
Secondary	Time to extubation	After stopping propofol infusion, When the patient breaths spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded. The patients will be followed for an expected average of 15 minutes.	From cessation of propofol infusion to extubation (sec)	No