Ketamine vs Hydromorphone
Primary Purpose
Laparoscopic Gastric Bypass, Obesity, Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Narcotics
pain scale
Sponsored by
About this trial
This is an interventional other trial for Laparoscopic Gastric Bypass
Eligibility Criteria
Inclusion Criteria:
- Obese patient presenting for laparoscopic gastric bypass between 18 and 65 years of age
Exclusion Criteria:
- Hypersensitivity, allergy, or contraindications to fentanyl, propofol, or ketamine.
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Non-Ketamine
Ketamine
Arm Description
This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.
This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.
Outcomes
Primary Outcome Measures
Pain Measured Based on Pain Medication Used on a Scale of 0-10
Used to translate the dose and route of each of the opioids the patient has received over the last 48 hours to a parenteral morphine equivalent using a standard conversion table. SD standard deviation, mg: milligrams, pain measured on a 0-10 scale
Secondary Outcome Measures
Length of Stay (Hours)
Length of stay compared between the 2 groups in hours.
Full Information
NCT ID
NCT03001843
First Posted
December 13, 2016
Last Updated
February 16, 2021
Sponsor
University of Florida
1. Study Identification
Unique Protocol Identification Number
NCT03001843
Brief Title
Ketamine vs Hydromorphone
Official Title
Does a Ketamine Infusion Decrease Post Operative Narcotic Consumption After Gastric Bypass Surgery?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
December 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will help to determine if investigators can minimize narcotic use in laparoscopic gastric bypass patients while maintaining adequate pain control. This will allow investigators to minimize the negative side effects of narcotics which is a goal in this population.
Detailed Description
The study will be a head to head observational study of patients who have undergone gastric bypass surgery. The methods of intraoperative anesthesiology will be Ketamine or Narcotic. Both are FDA approved methods of delivering anesthesia.
The amount of narcotics a patient receives is part of the medical record post-operatively will be followed from post-anesthesia care unit (PACU) through to discharge. The amount of narcotics needed to control the patient's pain (converted to morphine equivalent units) and pain scores (a hospital standard measure) will be collected for 48 hours for the study, or until discharge, whichever occurs sooner. The conversion to a morphine equivalent unit allows investigators to compare different narcotics the patient may receive in a more standardized way. The results will be analyzed and compared between the two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Gastric Bypass, Obesity, Pain, Postoperative
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-Ketamine
Arm Type
Active Comparator
Arm Description
This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.
Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
Anesthesia of only Ketamine
Intervention Type
Drug
Intervention Name(s)
Narcotics
Intervention Description
The narcotic group will receive no ketamine but rather a more standard anesthetic
Intervention Type
Behavioral
Intervention Name(s)
pain scale
Intervention Description
0-10 pain scale. 0 = no pain and 10 = worst pain
Primary Outcome Measure Information:
Title
Pain Measured Based on Pain Medication Used on a Scale of 0-10
Description
Used to translate the dose and route of each of the opioids the patient has received over the last 48 hours to a parenteral morphine equivalent using a standard conversion table. SD standard deviation, mg: milligrams, pain measured on a 0-10 scale
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Length of Stay (Hours)
Description
Length of stay compared between the 2 groups in hours.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Obese patient presenting for laparoscopic gastric bypass between 18 and 65 years of age
Exclusion Criteria:
Hypersensitivity, allergy, or contraindications to fentanyl, propofol, or ketamine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Smyth, MSN
Organizational Affiliation
Shands Hospital at the University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Ketamine vs Hydromorphone
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