Ketamine vs Hydromorphone

Phase 4

Completed

• Conditions: Obesity; Pain, Postoperative; Laparoscopic Gastric Bypass
• Interventions: Drug: Ketamine; Drug: Narcotics; Behavioral: pain scale

• Registration Number: NCT03001843
• Lead Sponsor: University of Florida

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-23
• Study Start: 2017-02-22
• Primary Completion: 2018-12-21
• Study Completion: 2018-12-21
• Results First Submitted: 2020-05-27
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-16
• Last Update Submitted: 2021-02-16
• Results First Posted: 2021-03-09
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Obese patient presenting for laparoscopic gastric bypass between 18 and 65 years of age

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Exclusion Criteria

• Hypersensitivity, allergy, or contraindications to fentanyl, propofol, or ketamine.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine	This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.
Non-Ketamine	pain scale	This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.
Non-Ketamine	Narcotics	This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.
Ketamine	pain scale	This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.

Primary Outcome Measures

Name	Time	Method
Pain Measured Based on Pain Medication Used on a Scale of 0-10	48 hours	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

Name	Time	Method
Length of Stay (Hours)	48 hours	Length of stay compared between the 2 groups in hours.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States