Ketamine vs Hydromorphone

University of Florida

Status and phase: Completed; Phase 4

Conditions: Laparoscopic Gastric Bypass; Pain, Postoperative; Obesity

Treatments: Drug: Ketamine; Behavioral: pain scale; Drug: Narcotics

Study type: Interventional

Funder types: Other

Identifiers

NCT03001843

IRB201500836 -A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Non-Ketamine

Active Comparator group

Description:

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

Treatment:

Behavioral: pain scale

Drug: Narcotics

Ketamine

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine

Behavioral: pain scale