A Phase 4 interventional study of Ketamine and placebo in Pain, Obesity and Hypoxia, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2019-10-07.
Sponsored by Northwestern University · Phase 4, Interventional, and Prevention
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.
1,232 studies on the registry are indexed under Hypoxia; 242 are open to participants now.
This study's enrollment of 80 is above the median of 45 across 854 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
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Exclusion Criteria:
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).
Drug: Ketamine
Group P (placebo) will receive the same amount of saline.
Drug: placebo
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).
Also known as: Ketalar
Group P (placebo) will receive the same amount of saline.
Also known as: Sterile .9 Normal Saline
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
Postoperative Opioid Consumption
Total number of opioids (morphine equivalents) consumed 24 hours after surgery
Time frame: 24 hours
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
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
| Milestone | Group K (Ketamine) | Group P (Placebo) |
|---|---|---|
| Started | 40 | 40 |
| Completed | 36 | 35 |
| Not completed | 4 | 5 |
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.
| score on a scale | Group K (Ketamine) | Group P (Placebo) |
|---|---|---|
| Quality of Recovery 40 | 170 (158 to 177) | 179 (166 to 187) |
Total number of opioids (morphine equivalents) consumed 24 hours after surgery
| Morphine Equivalents | Group K (Ketamine) | Group P (Placebo) |
|---|---|---|
| Postoperative Opioid Consumption | 4.45 (3 to 7.83) | 6.3 (3.6 to 10.1) |
Participants pain scores will be recorded at 24 hours after surgery. Pain scores range from 0 (no pain) to 10 (worst pain imaginable).
| score on a scale | Group K (Ketamine) | Group P (Placebo) |
|---|---|---|
| Postoperative Pain Scores | 4 (2.25 to 5.75) | 4 (2 to 5) |
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..
| days | Group K (Ketamine) | Group P (Placebo) |
|---|---|---|
| Length of Hospital Stay | 2.00 (2.00 to 2.75) | 2.00 (2.00 to 2.00) |
Collected over Time period for adverse events were collected was until discharge from hospital which is indefinite but generally up to 2 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group K (Ketamine) | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Group P (Placebo) | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Age, Categorical(Participants) | Group K (Ketamine) | Group P (Placebo) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 40 | 40 | 80 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Group K (Ketamine) | Group P (Placebo) | Total |
|---|---|---|---|
| Female | 35 | 27 | 62 |
| Male | 5 | 13 | 18 |
| Race and Ethnicity Not Collected(Participants) | Group K (Ketamine) | Group P (Placebo) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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