Effect of Ketamine on Postoperative Clinical Outcomes

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control

Loading and Infusion:

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

Group Type PLACEBO_COMPARATOR

Ketamine high-dose

Intervention Type DRUG

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

Ketamine low-dose

Intervention Type DRUG

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

Ketamine low-dose

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

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

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

Ketamine high-dose

Intervention Type DRUG

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

Ketamine high-dose

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

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

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

Ketamine low-dose

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

Ketamine high-dose

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

Intervention Type DRUG

Ketamine low-dose

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

Intervention Type DRUG

Other Intervention Names

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Saline Solution

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No