Ketamine vs Hydromorphone

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001843
• Other study ID #: IRB201500836 -A
• Status: Completed
• Phase: Phase 4
• Start date: February 22, 2017
• Est. completion date: December 21, 2018

Study information

• Verified date: February 2021
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Gastric Bypass
• Obesity
• Pain, Postoperative

Intervention

Drug:
• Ketamine
Anesthesia of only Ketamine
• 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

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of Stay (Hours)	Length of stay compared between the 2 groups in hours.	48 hours