Effect of Ketamine on Postoperative Clinical Outcomes

Study Overview
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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.

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.

Official Title
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Intraoperative Ketamine Administration in Colorectal Surgery: Effect on Postoperative Clinical Outcomes

Conditions
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Colorectal Surgery

Intervention / Treatment
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* Drug: Placebo
* Drug: Ketamine high-dose
* Drug: Ketamine low-dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients scheduled to undergo small and/or large partial bowel resection via laparotomy or laparoscopy Willingness and ability to sign an informed consent document No allergies to anesthetic or analgesic medications 18 - 80 years of age American Society of Anesthesiologists (ASA) Class I - III adults of either sex Exclusion Criteria Inability to comprehend the pain assessment tools Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications Patients with clinically-significant heart disease including arrhythmias and significant hypertension, brain aneurysms, prior history of cerebral vascular accident (CVA), or chronic renal insufficiency Prior abdominal surgery History of abdominal carcinomatosis History of radiation enteritis; Patients with history of hepatic, renal, cardiac failure, organ transplant, or diabetes Patients with seizures Morbid obesity (body mass index >40) Pregnant or lactating women Subjects with a history of alcohol or drug abuse within the past 3 months Any other conditions or use of any medication which may interfere with the conduct of the study Prophylactic Nasogastric Tube (NGT) use Individuals with significant manic disorders including: schizophrenia, or bipolar disorder or psychosis Individuals with asthma and/or thyroid diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate | Drug: Ketamine high-dose<br>* Loading: 1 mg/Kg Infusion: 10 mcg/kg/min<br>Drug: Ketamine low-dose<br>* Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min<br>|
| Active Comparator: Ketamine low-dose<br>Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min | Drug: Placebo<br>* Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate<br>* Other names: Saline Solution;Drug: Ketamine high-dose<br>* Loading: 1 mg/Kg Infusion: 10 mcg/kg/min<br>|
| Active Comparator: Ketamine high-dose<br>Loading: 1 mg/Kg Infusion: 10 mcg/kg/min | Drug: Placebo<br>* Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate<br>* Other names: Saline Solution;Drug: Ketamine low-dose<br>* Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Opioid Consumption | Perioperative use of opioid consumption at Post Anesthesia Care Unit (PACU) Data obtained from patient charts | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | Postoperative pain was measured at PACU using a Verbal Rating Scale (VRS) from 0 to 10 with 0 representing no pain and 10 very much pain. | one day | 
| Participants With Nausea and Vomiting at PACU | Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthetic adjuvant, opioid, Fentanyl, Pain management, Perioperative outcomes, Constipation, Ileus, Colorectal