Skip to main content
OpenTrials
Completed

NCT Number: NCT03001843

Ketamine vs Hydromorphone

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Laparoscopic Gastric Bypass Body Weight Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketamine

Drug

Anesthesia of only Ketamine

Other names: Ketalar

Narcotics

Drug

The narcotic group will receive no ketamine but rather a more standard anesthetic

Pain Scale

Behavioral

0-10 pain scale. 0 = no pain and 10 = worst pain

Primary outcomes

  1. Pain Measured Based on Pain Medication Used on a Scale of 0-10

    Time frame: 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 outcomes

  1. Length of Stay (Hours)

    Time frame: 48 hours

    Length of stay compared between the 2 groups in hours.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 23, 2016
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.