Laparoscopic Gastric Bypass, Obesity, Pain, Postoperative
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGKetamine
Anesthesia of only Ketamine
DRUGNarcotics
The narcotic group will receive no ketamine but rather a more standard anesthetic
BEHAVIORALpain scale
0-10 pain scale. 0 = no pain and 10 = worst pain
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Obese patient presenting for laparoscopic gastric bypass between 18 and 65 years of age
Exclusion criteria
* Hypersensitivity, allergy, or contraindications to fentanyl, propofol, or ketamine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Measured Based on Pain Medication Used on a Scale of 0-10 | 48 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay (Hours) | 48 hours | Length of stay compared between the 2 groups in hours. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 27 |
| 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 | 27 |
| Total | 54 |
Baseline characteristics
| Characteristic | Non-Ketamine | Ketamine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 27 participants | 27 participants | 54 participants |
| Sex: Female, Male Female | 21 Participants | 23 Participants | 44 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
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
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Ketamine | Pain Measured Based on Pain Medication Used on a Scale of 0-10 | 1.3 units on a scale | Standard Deviation 2.2 |
| Ketamine | Pain Measured Based on Pain Medication Used on a Scale of 0-10 | 0.7 units on a scale | Standard Deviation 1.5 |
Secondary
Length of Stay (Hours)
Length of stay compared between the 2 groups in hours.
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Ketamine | Length of Stay (Hours) | 43.6 hours | Standard Deviation 20.6 |
| Ketamine | Length of Stay (Hours) | 39.8 hours | Standard Deviation 14.5 |