NCT01997515

Ketamine Effect After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study

Ketamine Effect on Recovery and Respiratory Outcomes After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Obesity
• Hypoxia

Interventions

Type	Name	Description
DRUG	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).
DRUG	placebo	Group P (placebo) will receive the same amount of saline.

Timeline

• Start date: 2013-11-01
• Primary completion: 2019-07-26
• Completion: 2019-08-22
• First posted: 2013-11-28
• Last updated: 2019-10-07
• Results posted: 2019-10-07

Locations

1 site across 1 country: United States