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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01997515
Recruitment Status : Completed
First Posted : November 28, 2013
Results First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Meltem Yilmaz, Northwestern University

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.


Condition or disease Intervention/treatment Phase
Pain Obesity Hypoxia Drug: Ketamine Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ketamine Effect on Recovery and Respiratory Outcomes After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study
Actual Study Start Date : November 2013
Actual Primary Completion Date : July 26, 2019
Actual Study Completion Date : August 22, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Group K (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: 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).
Other Name: Ketalar

Placebo Comparator: Group P (Placebo)
Group P (placebo) will receive the same amount of saline.
Drug: placebo
Group P (placebo) will receive the same amount of saline.
Other Name: Sterile .9 Normal Saline




Primary Outcome Measures :
  1. Quality of Recovery 40 [ Time Frame: 24 hours ]
    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.


Secondary Outcome Measures :
  1. Postoperative Opioid Consumption [ Time Frame: 24 hours ]
    Total number of opioids (morphine equivalents) consumed 24 hours after surgery

  2. Postoperative Pain Scores [ Time Frame: 24 hours ]
    Participants pain scores will be recorded at 24 hours after surgery. Pain scores range from 0 (no pain) to 10 (worst pain imaginable).

  3. Length of Hospital Stay [ Time Frame: Up to 2 weeks ]
    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..



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997515


Locations
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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Meltem Yilmaz, MD Northwestern University
  Study Documents (Full-Text)

Documents provided by Meltem Yilmaz, Northwestern University:
Publications:
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Responsible Party: Meltem Yilmaz, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01997515    
Other Study ID Numbers: STU00081191
First Posted: November 28, 2013    Key Record Dates
Results First Posted: October 7, 2019
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Meltem Yilmaz, Northwestern University:
Quality of Recovery 40 Questionaire
Pain
Hypoxia
Gastric Surgery
Obesity
Ketamine
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action