Effect of Ketamine on Postoperative Clinical Outcomes

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

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Surgery
• Intervention / Treatment: Drug: Ketamine high-dose; Drug: Ketamine low-dose; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Roya Yumul, MD PhD, Cedars-Sinai Medical Center; Study Director: Roya Yumul, MD., PhD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 1, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: opioid; Constipation; Pain management; Fentanyl; Anesthetic adjuvant; Perioperative outcomes; Colorectal; Ileus
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: Pro00024533