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Recruitment challenges
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The aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea.
Obstructive sleep apnea (OSA) affects millions of people in the U.S., and currently, there is not a well-established, general anesthetic technique that clearly decreases the risk of postoperative respiratory complications in these patients. If OSA patients have significantly decreased postoperative opioid requirements and improved recovery profiles in the PACU, the protocol could have significant implications in defining future standardized general anesthesia recommendations for patients with this disease. Ultimately, the aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea. The objective of this study is to compare the postoperative recovery profile of OSA patients receiving standard Sevoflurane inhaled anesthesia with normal saline infusion versus Sevoflurane combined with a low-dose ketamine infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | OSA patients will receive standard inhaled anesthesia with normal saline infusion |
|
| Ketamine Group | Active Comparator | OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | Visual Analog Scale pain rating | up to 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Score | Patients will rate their quality of anesthesia services | At 24 hrs post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter A Nagi, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Department of Anesthesiology and Perioperative Medicine | Birmingham | Alabama | 35249 | United States |
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Three participants were excluded prior to randomization due to the following reasons:
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | OSA patients will receive standard inhaled anesthesia with normal saline infusion Control: OSA patients receiving standard inhaled anesthesia combined with normal saline |
| FG001 | Ketamine Group | OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion. Ketamine: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | OSA patients will receive standard inhaled anesthesia with normal saline infusion Control: OSA patients receiving standard inhaled anesthesia combined with normal saline |
| BG001 | Ketamine Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Pain Scores | Visual Analog Scale pain rating | Study was terminated. Data was not collected. | Posted | up to 24 hours postoperatively |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | OSA patients will receive standard inhaled anesthesia with normal saline infusion Control: OSA patients receiving standard inhaled anesthesia combined with normal saline |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Sturdivant | University of Alabama at Birmingham | 205-934-4042 | Adamsturdivant@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2010 | Oct 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Control | Procedure | OSA patients receiving standard inhaled anesthesia combined with normal saline |
|
OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.
Ketamine: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
| Secondary | Patient Satisfaction Score | Patients will rate their quality of anesthesia services | Participants were not analyzed due to study being terminated. Data was not collected. | Posted | At 24 hrs post-op |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Ketamine Group | OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion. Ketamine: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight | 0 | 4 | 0 | 4 | 0 | 4 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |