Effect of Ketamine on Postoperative Clinical Outcomes

Cedars-Sinai Medical Center

Status and phase: Terminated; Phase 4

Conditions: Colorectal Surgery

Treatments: Drug: Placebo; Drug: Ketamine high-dose; Drug: Ketamine low-dose

Study type: Interventional

Funder types: Other

Identifiers

NCT01365195

Pro00024533

Details and patient eligibility

About

The purpose of this research is to evaluate the effectiveness of ketamine as an analgesic adjuvant in decreasing the narcotic (opioids) analgesics during surgery, on pain management and on the later recovery after surgery in patients undergoing colorectal surgery.

Full description

Adjuvant is a drug that has few or no pharmacological effects by itself, but may increase the effectiveness or strength of other drugs when given at the same time.

Enrollment: 21 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Patients scheduled to undergo small and/or large partial bowel resection via laparotomy or laparoscopy
2. Willingness and ability to sign an informed consent document
3. No allergies to anesthetic or analgesic medications
4. 18 - 80 years of age
5. American Society of Anesthesiologists (ASA) Class I - III adults of either sex

Exclusion Criteria

1. Inability to comprehend the pain assessment tools
2. Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications
3. Patients with clinically-significant heart disease including arrhythmias and significant hypertension, brain aneurysms, prior history of cerebral vascular accident (CVA), or chronic renal insufficiency
4. Prior abdominal surgery
5. History of abdominal carcinomatosis
6. History of radiation enteritis;
7. Patients with history of hepatic, renal, cardiac failure, organ transplant, or diabetes
8. Patients with seizures
9. Morbid obesity (body mass index >40)
10. Pregnant or lactating women
11. Subjects with a history of alcohol or drug abuse within the past 3 months
12. Any other conditions or use of any medication which may interfere with the conduct of the study
13. Prophylactic Nasogastric Tube (NGT) use
14. Individuals with significant manic disorders including: schizophrenia, or bipolar disorder or psychosis
15. Individuals with asthma and/or thyroid diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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21 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate

Treatment:

Drug: Ketamine low-dose

Drug: Ketamine high-dose

Ketamine low-dose

Active Comparator group

Description:

Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min

Treatment:

Drug: Placebo

Drug: Ketamine high-dose

Ketamine high-dose

Active Comparator group

Description:

Loading: 1 mg/Kg Infusion: 10 mcg/kg/min

Treatment:

Drug: Ketamine low-dose

Drug: Placebo