Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study hypothesizes that adding 60% nitrous oxide to a steady state sevoflurance or propofol anesthetic will lead to a decrease in both BIS and Entropy indices during a constant level of surgical stimulus
Nitrous oxide is a widely used general anesthetic pas. It is often used in addition to a second, more potent agent. BIS and Entropy are depth of anesthesia monitors in clinical use. There are conflicting reports about the usefulness of these monitors when nitrous oxide is used as a part of the anesthetic regimen. While some studies demonstrate a decrease in BIS and Entropy, this study aims to investigate the effects of adding nitrous oxide to a sevoflurane or a propofol based anesthetic on BIS and Entropy indices.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane group | Active Comparator | Sevoflurane based general anesthesia |
|
| Propofol group | Active Comparator | Propofol based general anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane group | Drug | Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Effect of Nitrous Oxide on Bispectral Index (BIS) and State Entropy Index (SE) | We planned this study to compare the effect of adding N2O on BIS and SE during an intravenous or an inhalation anesthetic. We hypothesized that neither BIS nor SE would decrease in response to the addition of N2O to a Propofol anesthetic. We also hypothesized that neither BIS nor SE would decrease in participants under Sevoflurane anesthesia if the inspired concentration of Sevoflurane were carefully and continuously adjusted to maintain a constant end-tidal concentration during the addition and discontinuation of N2O. BIS (0-100) and SE (0-92) are unitless, ordinal indices of anesthetic depth. Both indices are decreased when the depth of anesthesia is increased. | From baseline to 20 minutes after the addition of 60% nitrous oxide |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mehmet S Ozcan, M.D. | Univeristy of Illinois Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73152 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14722164 | Background | Anderson RE, Jakobsson JG. Entropy of EEG during anaesthetic induction: a comparative study with propofol or nitrous oxide as sole agent. Br J Anaesth. 2004 Feb;92(2):167-70. doi: 10.1093/bja/aeh036. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients were randomized into 2 groups that differ in the choice of the agent for the maintenance of general anesthesia: sevoflurane or propofol.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Propofol Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Effect of Nitrous Oxide on Bispectral Index (BIS) and State Entropy Index (SE) | We planned this study to compare the effect of adding N2O on BIS and SE during an intravenous or an inhalation anesthetic. We hypothesized that neither BIS nor SE would decrease in response to the addition of N2O to a Propofol anesthetic. We also hypothesized that neither BIS nor SE would decrease in participants under Sevoflurane anesthesia if the inspired concentration of Sevoflurane were carefully and continuously adjusted to maintain a constant end-tidal concentration during the addition and discontinuation of N2O. BIS (0-100) and SE (0-92) are unitless, ordinal indices of anesthetic depth. Both indices are decreased when the depth of anesthesia is increased. | Posted | Mean | Standard Deviation | units on a scale | From baseline to 20 minutes after the addition of 60% nitrous oxide |
|
Patients were monitored for the adverse event from start of the surgery until the patient was discharged from the post anesthesia care unit.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mehmet Ozcan, MD | Department of Anesthesia. OUHSC | 405-271-4351 | mehmet-ozcan@ouhsc.edu |
Not provided
| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Propofol group | Drug | Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture. |
|
|
Propofol based general anesthesia
Propofol group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | 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. |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. | 0 | 14 | 0 | 14 | 0 | 14 |
Not provided
Not provided
| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |