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Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after surgery and general anesthesia. The results of our observational study indicate that 42.7% of patients require medication to treat PONV in the first 24 hours after bariatric surgery despite our aggressive perioperative approach with triple prophylaxis. Common risk factors for PONV are the use of intraoperative narcotics and anesthetic gases.
Preliminary results of multimodal postoperative analgesia in the first 24 hours lead to a reduction of narcotic consumption, desaturations and use of antiemetic medication.
Our study hypothesis is that different types of anesthetics reduce PONV further.
Patient would be randomly assigned to receive either our current intraoperative management or a narcotic free, total intravenous general anesthetic (TIVA).
The investigators hope to improve patients' satisfaction by reducing PONV in the postoperative period.
See above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balanced Anesthesia | No Intervention | Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. | |
| NoNarc TIVA | Active Comparator | Patients will receive narcotic free total intravenous anesthesia with Propofol, dexmedetomidine and ketamine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIVA NoNarc | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| PONV During the First 24 Hours After Bariatric Surgery | Postoperative Nausea and Vomiting | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Requiring Antiemetic Rescue Medication (AERM) | 24hours | |
| PONV Between Different Surgical Procedures (Percentage of Participants) | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Ziemann-Gimmel, MD | Coastal Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flagler Hospital | Saint Augustine | Florida | 32086 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24554545 | Derived | Ziemann-Gimmel P, Goldfarb AA, Koppman J, Marema RT. Opioid-free total intravenous anaesthesia reduces postoperative nausea and vomiting in bariatric surgery beyond triple prophylaxis. Br J Anaesth. 2014 May;112(5):906-11. doi: 10.1093/bja/aet551. Epub 2014 Feb 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Classic/Balanced Anesthesia | Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. (Control) postop management in both groups is similar in both groups |
| FG001 | TIVA | TIVA NoNarc (Study): - patients in both groups receive antiemetic prophylaxis - patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Classic/Balanced Anesthesia | Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice.
|
| BG001 |
| 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 | PONV During the First 24 Hours After Bariatric Surgery | Postoperative Nausea and Vomiting | Posted | Number | participants | 24 hours |
|
|
24hours
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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 | Classic/Balanced Anesthesia | Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. (Control) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Ziemann-Gimmel, MD | Coastal Anesthesiology | 904-819-4478 | pziemann@yahoo.com |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| respiratory failure |
|
| TIVA |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Number of Patients Requiring Antiemetic Rescue Medication (AERM) | Posted | Number | participants | 24hours |
|
|
|
| Secondary | PONV Between Different Surgical Procedures (Percentage of Participants) | analysis was conducted with all participants and NOT per arm | Posted | Number | percentage of participants | 24 hours |
|
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | TIVA | patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively | 0 | 60 | 0 | 60 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| revision LRYGB |
|
| Conversion to LRYGB |
|