Ketamine vs Hydromorphone

Does a Ketamine Infusion Decrease Post Operative Narcotic Consumption After Gastric Bypass Surgery?

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Pain, Postoperative; Laparoscopic Gastric Bypass
• Intervention / Treatment: Drug: Narcotics; Behavioral: pain scale; Drug: Ketamine

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-Ketamine; This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.	Drug: Narcotics; The narcotic group will receive no ketamine but rather a more standard anesthetic; Behavioral: pain scale; 0-10 pain scale. 0 = no pain and 10 = worst pain
Active Comparator: Ketamine; This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.	Behavioral: pain scale; 0-10 pain scale. 0 = no pain and 10 = worst pain; Drug: Ketamine; Anesthesia of only Ketamine; Other Names: Ketalar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay (Hours)	Length of stay compared between the 2 groups in hours.	48 hours

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: David M Smyth, MSN, Shands Hospital at the University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2017
• Primary Completion (Actual): December 21, 2018
• Study Completion (Actual): December 21, 2018

Study Registration Dates

• First Submitted: December 13, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (Estimate): December 23, 2016

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine; Narcotics
• Other Study ID Numbers: IRB201500836 -A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No