Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Nausea and Vomiting |
Drug: TIVA NoNarc |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting (PONV) in Bariatric Surgery |
- PONV during the first 48 hours after bariatric surgery [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Patient satisfaction with perioperative treatment [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
| Enrollment: | 125 |
| Study Start Date: | November 2011 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Balanced Anesthesia
Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice.
|
Drug: TIVA NoNarc
|
Detailed Description:
See above
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All patients scheduled for bariatric surgery at Flagler Hospital will be included after written and informed consent.
Exclusion Criteria:
- Patients will be excluded from the study if they don't consent to participate in the study. Patients allergic to any of the study medication will be excluded. Patients with second or third degree heart block will be excluded.
Contacts and Locations| United States, Florida | |
| Flagler Hospital | |
| St. Augustine, Florida, United States, 32086 | |
| Principal Investigator: | Patrick Ziemann-Gimmel, MD | Coastal Anesthesiology |
More Information
No publications provided
| Responsible Party: | Patrick Ziemann-Gimmel, MD, Anesthesiologist, Principal Investigator, Coastal Anesthesiology Consultants |
| ClinicalTrials.gov Identifier: | NCT01449708 History of Changes |
| Other Study ID Numbers: | 3766 - 6886 |
| Study First Received: | October 6, 2011 |
| Last Updated: | October 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Coastal Anesthesiology Consultants:
|
Bariatric Surgery TIVA PONV non-opioid OSA |
Additional relevant MeSH terms:
|
Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Signs and Symptoms Postoperative Complications Pathologic Processes |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013