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
This study will help to determine if investigators can minimize narcotic use in laparoscopic gastric bypass patients while maintaining adequate pain control. This will allow investigators to minimize the negative side effects of narcotics which is a goal in this population.
The study will be a head to head observational study of patients who have undergone gastric bypass surgery. The methods of intraoperative anesthesiology will be Ketamine or Narcotic. Both are FDA approved methods of delivering anesthesia.
The amount of narcotics a patient receives is part of the medical record post-operatively will be followed from post-anesthesia care unit (PACU) through to discharge. The amount of narcotics needed to control the patient's pain (converted to morphine equivalent units) and pain scores (a hospital standard measure) will be collected for 48 hours for the study, or until discharge, whichever occurs sooner. The conversion to a morphine equivalent unit allows investigators to compare different narcotics the patient may receive in a more standardized way. The results will be analyzed and compared between the two groups.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Ketamine | Active Comparator | This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine. |
|
| Ketamine | Active Comparator | This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Anesthesia of only Ketamine |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Measured Based on Pain Medication Used on a Scale of 0-10 | Used to translate the dose and route of each of the opioids the patient has received over the last 48 hours to a parenteral morphine equivalent using a standard conversion table. SD standard deviation, mg: milligrams, pain measured on a 0-10 scale | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay (Hours) | Length of stay compared between the 2 groups in hours. | 48 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David M Smyth, MSN | Shands Hospital at the University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Non-Ketamine | This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine. Narcotics: The narcotic group will receive no ketamine but rather a more standard anesthetic pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain |
| FG001 | Ketamine | This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain. Ketamine: Anesthesia of only Ketamine pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Non-Ketamine | This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine. Narcotics: The narcotic group will receive no ketamine but rather a more standard anesthetic pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Data not collected |
| 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 Measured Based on Pain Medication Used on a Scale of 0-10 | Used to translate the dose and route of each of the opioids the patient has received over the last 48 hours to a parenteral morphine equivalent using a standard conversion table. SD standard deviation, mg: milligrams, pain measured on a 0-10 scale | Posted | Mean | Standard Deviation | units on a scale | 48 hours |
|
90 days
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 | Non-Ketamine | This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine. Narcotics: The narcotic group will receive no ketamine but rather a more standard anesthetic pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Sappenfield, MD | University of Florida | 352-273-5259 | jsappenfield@anest.ufl.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 22, 2017 | Aug 14, 2020 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 3, 2019 | Aug 14, 2020 | ICF_003.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007649 | Ketamine |
| D009294 | Narcotics |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Narcotics | Drug | The narcotic group will receive no ketamine but rather a more standard anesthetic |
|
| pain scale | Behavioral | 0-10 pain scale. 0 = no pain and 10 = worst pain |
|
| Ketamine |
This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain. Ketamine: Anesthesia of only Ketamine pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Data not collected | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.
Ketamine: Anesthesia of only Ketamine
pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain
|
|
| Secondary | Length of Stay (Hours) | Length of stay compared between the 2 groups in hours. | Posted | Mean | Standard Deviation | hours | 48 hours |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Ketamine | This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain. Ketamine: Anesthesia of only Ketamine pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain | 0 | 27 | 0 | 27 | 0 | 27 |
Not provided
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|