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Addition of Nitrous Oxide and Its Effects on Depth of Anesthesia (N20)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00717574
First received: July 9, 2008
Last updated: June 29, 2017
Last verified: June 2017
Results First Received: April 7, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions: Deep Sedation
Anesthesia, General
Interventions: Drug: Sevoflurane group
Drug: Propofol group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study includes patients aged 18 to 55 years who were classified as ASA physical status ≤2 and scheduled to have surgery under general anesthesia . Only patients for which intraoperative Entropy or BIS monitoring was planned were enrolled by speaking to the attending anesthesiologists working at the OU Presbyterian hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomized into 2 groups that differ in the choice of the agent for the maintenance of general anesthesia: sevoflurane or propofol.

Reporting Groups
  Description
Sevoflurane Group

Sevoflurane based general anesthesia

Sevoflurane group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.

Propofol Group

Propofol based general anesthesia

Propofol group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.


Participant Flow:   Overall Study
    Sevoflurane Group   Propofol Group
STARTED   16   16 
COMPLETED   14   14 
NOT COMPLETED   2   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sevoflurane Group

Sevoflurane based general anesthesia

Sevoflurane group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.

Propofol Group

Propofol based general anesthesia

Propofol group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.

Total Total of all reporting groups

Baseline Measures
   Sevoflurane Group   Propofol Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   14   28 
Age 
[Units: Years]
Mean (Standard Deviation)
 39  (10)   38  (9.6)   38.7  (9.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  57.1%      10  71.4%      18  64.3% 
Male      6  42.9%      4  28.6%      10  35.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   7.1%      0   0.0%      1   3.6% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2  14.3%      3  21.4%      5  17.9% 
White      9  64.3%      10  71.4%      19  67.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      2  14.3%      1   7.1%      3  10.7% 
Region of Enrollment 
[Units: Participants]
     
United States   14   14   28 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 31  (6)   32  (10)   31.5  (8) 


  Outcome Measures

1.  Primary:   The Effect of Nitrous Oxide on Bispectral Index (BIS) and State Entropy Index (SE)   [ Time Frame: From baseline to 20 minutes after the addition of 60% nitrous oxide ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  1. We did not measure the blood concentrations of Sevoflurane.
  2. Variety of surgical procedures might have lead to different levels of noxious stimuli.
  3. Noxious stimuli and administration of opioids may affect EEG-derived indices.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Mehmet Ozcan, MD
Organization: Department of Anesthesia. OUHSC
phone: 405-271-4351
e-mail: mehmet-ozcan@ouhsc.edu


Publications:

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00717574     History of Changes
Other Study ID Numbers: 13800
Study First Received: July 9, 2008
Results First Received: April 7, 2017
Last Updated: June 29, 2017