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

Primary Purpose

Pain, Obesity, Hypoxia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketamine
placebo
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring Quality of Recovery 40 Questionaire, Pain, Hypoxia, Gastric Surgery, Obesity, Ketamine

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwestern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group K (Ketamine)

Group P (Placebo)

Arm Description

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).

Group P (placebo) will receive the same amount of saline.

Outcomes

Primary Outcome Measures

Quality of Recovery 40
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

Postoperative Opioid Consumption
Total number of opioids (morphine equivalents) consumed 24 hours after surgery
Postoperative Pain Scores
Participants pain scores will be recorded at 24 hours after surgery. Pain scores range from 0 (no pain) to 10 (worst pain imaginable).
Length of Hospital Stay
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..

Full Information

First Posted
November 18, 2013
Last Updated
October 3, 2019
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01997515
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
July 26, 2019 (Actual)
Study Completion Date
August 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Obesity, Hypoxia
Keywords
Quality of Recovery 40 Questionaire, Pain, Hypoxia, Gastric Surgery, Obesity, Ketamine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group K (Ketamine)
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Group P (Placebo)
Arm Type
Placebo Comparator
Arm Description
Group P (placebo) will receive the same amount of saline.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Sterile .9 Normal Saline
Intervention Description
Group P (placebo) will receive the same amount of saline.
Primary Outcome Measure Information:
Title
Quality of Recovery 40
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Postoperative Opioid Consumption
Description
Total number of opioids (morphine equivalents) consumed 24 hours after surgery
Time Frame
24 hours
Title
Postoperative Pain Scores
Description
Participants pain scores will be recorded at 24 hours after surgery. Pain scores range from 0 (no pain) to 10 (worst pain imaginable).
Time Frame
24 hours
Title
Length of Hospital Stay
Description
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..
Time Frame
Up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meltem Yilmaz, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17952107
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.
Results Reference
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Ketamine Effect After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study

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