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Phase 4 N=80 Randomized Triple-blind Prevention

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

Pain · Obesity · Hypoxia

Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Quality of Recovery 40 — 170; 179 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Ketamine (Drug); placebo (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Northwestern University
Primary completion
Jul 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Quality of Recovery 40
170; 179
SECONDARY
Postoperative Opioid Consumption
4.45; 6.3
SECONDARY
Postoperative Pain Scores
4; 4
SECONDARY
Length of Hospital Stay
2.00; 2.00

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01997515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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