Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol

• Sponsor: DongGuk University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01531491
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Intravenous; Anesthesia Recovery Period	Procedure: Rebreathing tube; Procedure: No rebreathing tube (Nothing)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Official Title: Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol: a Pilot Study
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hypercapnia group 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; 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.
Experimental: Hypocapnia group 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); 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.

Outcome Measures

Primary Outcome Measures

1. Time to open eyes under investigator's command [From cessation of propofol infusion to patient's eye opening (seconds)]

   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.

Secondary Outcome Measures

1. Time to breath spontaneously [From cessation of propofol infusion to patient's spontaneous breathing (sec)]

   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.

2. Change of bispectral index (BIS) [From the cessation of propofol infusion to extubation, BIS and time (seconds) will be recorded.]

   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.

3. Time to open mouth under investigator's command [From cessation of propofol infusion to patient's mouth opening (seconds)]

   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.

4. Time to extubation [From cessation of propofol infusion to extubation (sec)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital	Goyang	Kyunggido	Korea, Republic of	140-773

Sponsors and Collaborators

• DongGuk University

Investigators

• Principal Investigator: Junyong In, M.D., Department of anesthesiology and pain medicine, Dongguk University Ilsan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Junyong In, MD, Associate professor, DongGuk University
• ClinicalTrials.gov Identifier: NCT01531491
• Other Study ID Numbers: J In 2011-3
• First Posted: Feb 13, 2012
• Last Update Posted: Feb 16, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by Junyong In, MD, Associate professor, DongGuk University: Emergence; Hypercapnia; Hypocapnia; Propofol
• Additional relevant MeSH terms: Hypercapnia

Study Results

No Results Posted as of Feb 16, 2015