Hypoxia, Obesity, Pain
Conditions
Keywords
Quality of Recovery 40 Questionaire, Pain, Hypoxia, Gastric Surgery, Obesity, Ketamine
Brief summary
Laparoscopic surgery for gastric reduction is frequently associated with high levels of postoperative pain. Postoperative pain is very often treated with opioids. However large doses of opioids can result in respiratory depression with hypoxemia especially in high risk patients with obstructive sleep apnea. since a large group of patients undergoing surgery for gastric reduction surgery also have obstructive sleep apnea, it is expected that these patients are also at high risk for postoperative respiratory depression and hypoxemia. Intraoperative ketamine has been used as an effective multimodal agent to reduce postoperative pain. However, ketamine alone has not been examined to improve postoperative pain outcomes in patients undergoing gastric reduction surgery. More importantly, it is unknown if the use of intraoperative ketamine can lead to better overall quality of recovery in the same patient population. In addition, ketamine has been shown to improve ventilation but it remains to be determined if the intraoperative use of ketamine will result in less postoperative hypoxemic events. The main objective of the current investigation is to examine the effect of intraoperative ketamine on postoperative quality of recovery after gastric reduction surgery. The investigators hypothesize that subjects receiving ketamine will have a greater global quality of recovery score than the ones receiving saline.
Interventions
DRUGKetamine
Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).
DRUGplacebo
Group P (placebo) will receive the same amount of saline.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-64 * surgery: laparoscopic gastric reduction (gastric sleeve or gastric bypass) * ASA physical status classification I, II, III * Body Mass Index \>35kg/m2 * Fluent in English
Exclusion criteria
* History of allergy to protocol medications * History of chronic opioid use * Pregnant patients * Drop out: Conversion to an open surgical route, patient or surgeon request.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery 40 | 24 hours | Scores on QOR (quality of recovery) 40 questionnaire. The QoR-40 score, which ranges from 40 to 200, representing very poor (low scores) to outstanding quality of recovery (high scores), respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Opioid Consumption | 24 hours | Total number of opioids (morphine equivalents) consumed 24 hours after surgery |
| Postoperative Pain Scores | 24 hours | Participants pain scores will be recorded at 24 hours after surgery. Pain scores range from 0 (no pain) to 10 (worst pain imaginable). |
| Length of Hospital Stay | Up to 2 weeks | The subjects length of hospital stay will be recorded. Length of stay is defined as day of surgery to date of discharge from the hospital which may be up to 2 weeks.. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group K (Ketamine) Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight). | 40 |
| Group P (Placebo) Group P (placebo) will receive the same amount of saline. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Group K (Ketamine) | Group P (Placebo) | 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 | 40 Participants | 40 Participants | 80 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 35 Participants | 27 Participants | 62 Participants |
| Sex: Female, Male Male | 5 Participants | 13 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Quality of Recovery 40
Scores on QOR (quality of recovery) 40 questionnaire. The QoR-40 score, which ranges from 40 to 200, representing very poor (low scores) to outstanding quality of recovery (high scores), respectively.
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group K (Ketamine) | Quality of Recovery 40 | 170 score on a scale |
| Group P (Placebo) | Quality of Recovery 40 | 179 score on a scale |
Secondary
Length of Hospital Stay
The subjects length of hospital stay will be recorded. Length of stay is defined as day of surgery to date of discharge from the hospital which may be up to 2 weeks..
Time frame: Up to 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group K (Ketamine) | Length of Hospital Stay | 2.00 days |
| Group P (Placebo) | Length of Hospital Stay | 2.00 days |
Secondary
Postoperative Opioid Consumption
Total number of opioids (morphine equivalents) consumed 24 hours after surgery
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group K (Ketamine) | Postoperative Opioid Consumption | 4.45 Morphine Equivalents |
| Group P (Placebo) | Postoperative Opioid Consumption | 6.3 Morphine Equivalents |
Secondary
Postoperative Pain Scores
Participants pain scores will be recorded at 24 hours after surgery. Pain scores range from 0 (no pain) to 10 (worst pain imaginable).
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group K (Ketamine) | Postoperative Pain Scores | 4 score on a scale |
| Group P (Placebo) | Postoperative Pain Scores | 4 score on a scale |