Ketamine Effect After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study
Status: | Active, not recruiting |
---|---|
Conditions: | Chronic Pain, Obesity Weight Loss, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Musculoskeletal |
Healthy: | No |
Age Range: | 18 - 64 |
Updated: | 12/27/2017 |
Start Date: | November 2013 |
End Date: | October 2018 |
Ketamine Effect on Recovery and Respiratory Outcomes After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study
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. The investigators also seek to determine if
intraoperative ketamine would decrease the incidence of postoperative hypoxemic events in the
same patient population.
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. The investigators also seek to determine if
intraoperative ketamine would decrease the incidence of postoperative hypoxemic events in the
same patient population.
Inclusion Criteria:
- Age 18-64
- surgery: laparoscopic gastric reduction (gastric sleeve or gastric bypass)
- ASA I, II, III
- BMI >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.
We found this trial at
1
site
251 E Huron St
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Meltem Yilmaz, MD
Phone: 312-695-0061
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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