Ketamine vs Hydromorphone

NCT03001843 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB201500836 -A
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Gastric Bypass; Obesity; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Length of Stay (Hours)

  48 hours

Study Arms (2)

Non-Ketamine

ACTIVE COMPARATOR

This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.

Drug: Narcotics; Behavioral: pain scale

Ketamine

ACTIVE COMPARATOR

This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.

Drug: Ketamine; Behavioral: pain scale

Interventions

Ketamine DRUG

Anesthesia of only Ketamine

Also known as: Ketalar

Ketamine

Narcotics DRUG

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

Non-Ketamine

pain scale BEHAVIORAL

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

Ketamine; Non-Ketamine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Obesity; Pain, Postoperative

Interventions

Ketamine; Narcotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Joshua Sappenfield, MD
• Organization: University of Florida

jsappenfield@anest.ufl.edu

352-273-5259

Study Officials

• David M Smyth, MSN

  Shands Hospital at the University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 23, 2016
• Study Start: February 22, 2017
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: March 9, 2021
• Results First Posted: March 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)