Clinical trial NCT01997515: Ketamine Effect After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study
Official title: Ketamine Effect on Recovery and Respiratory Outcomes After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Obesity
Hypoxia
Keywords: Quality of Recovery 40 Questionaire
Pain
Hypoxia
Gastric Surgery
Obesity
Ketamine
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Recovery 40
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative Opioid Consumption
timeFrame: 24 hours
measure: Postoperative Pain Scores
timeFrame: 24 hours
measure: Length of Hospital Stay
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Meltem Yilmaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han PY, Duffull SB, Kirkpatrick CM, Green B. Dosing in obesity: a simple solution to a big problem. Clin Pharmacol Ther. 2007 Nov;82(5):505-8. doi: 10.1038/sj.clpt.6100381.