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The morbidly obese bariatric surgery population is susceptible to opioid-induced complications such as respiratory depression and postoperative nausea and vomiting. This population may in particular benefit from opioid-sparing or opioid-free anesthetic techniques. This study aims to evaluate the effect of opioid free total intravenous anesthesia on postoperative quality of recovery in patients undergoing bariatric surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid Free Anesthesia Group | Experimental |
| |
| Opioid Anesthesia Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid Free Total Intravenous Anesthesia | Combination Product | Total intravenous anesthesia with propofol and dexmedetomidine hydrochloride and ketamine hydrochloride |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery | Quality of Recovery (QoR-15), a patient-reported outcome questionnaire that assesses the quality of functional recovery after surgery and anesthesia with a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). | Up to two postoperative weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensities | Postoperative pain intensities using a 0 to 10 numerical rating scale (NRS) with higher scores indicative of higher pain intensities. | Up to postoperative day one |
| Opioid Consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Nausea and Vomiting | The incidence of any postoperative nausea, retching, or vomiting. | Up to postoperative day one |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Aronsohn, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
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| ID | Term |
|---|---|
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Total Intravenous anesthesia with opioid | Combination Product | Total Intravenous anesthesia with opioid |
|
Total postoperative opioid consumption
| Up to postoperative day one |
| Time to Aldrete Score of 9 | Time to post-anesthesia care unit discharge readiness | Up to postoperative day one |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |