Effect of Ketamine on Postoperative Clinical Outcomes

Ketamine

Brief Summary

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.

Intervention / Treatment

  • Placebo (DRUG)
    Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate
  • Ketamine high-dose (DRUG)
    Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
  • Ketamine low-dose (DRUG)
    Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min

Condition or Disease

  • Colorectal Surgery

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years to 80 Years
    Enrollment: 21 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: May 01, 2011
    Primary Completion: Dec 01, 2014 ACTUAL
    Completion Date: Dec 01, 2014 ACTUAL
    Study First Posted: Jun 03, 2011 ESTIMATED
    Results First Posted: Mar 02, 2022 ACTUAL
    Last Updated: Feb 09, 2022

    Sponsors / Collaborators

    Lead Sponsor: Cedars-Sinai Medical Center
    Responsible Party: N/A

    Location

    Los Angeles, California, USA

    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.

    Participant Groups

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

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

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 80
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Perioperative use of opioid consumption at Post Anesthesia Care Unit (PACU) Data obtained from patient charts

    Secondary Outcomes

    • 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.

    • Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting.

    More Details

    NCT Number: NCT01365195
    Other IDs: Pro00024533
    Study URL: https://clinicaltrials.gov/study/NCT01365195
    Last updated: Sep 29, 2023