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Effect of Ketamine on Postoperative Clinical Outcomes

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01365195
First received: June 1, 2011
Last updated: September 26, 2014
Last verified: September 2014

June 1, 2011
September 26, 2014
May 2011
March 2016   (final data collection date for primary outcome measure)
Opioid consumption obtained from the recorded data [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts) Post discharge use of opioid consumption (data obtained from the follow up questionnaires approximately one week after surgery).

And from the next postoperative visit (one month) after surgery.

Same as current
Complete list of historical versions of study NCT01365195 on ClinicalTrials.gov Archive Site
  • Postoperative pain using a Verbal Rating Scale [ Time Frame: one month ] [ Designated as safety issue: No ]
    Postoperative will be measured at PACU, one week after surgery and at the next postoperative vist (one month) after surgery.
  • Nausea and vomiting will be measured with follow up [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU, one week after surgery and at the next postoperative vist (one month) after surgery.
  • Constipation (Ileus) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    at PACU, one week after surgery and at the next postoperative vist (one month) after surgery.
  • Postoperative pain using a Verbal Rating Scale [ Time Frame: one month ] [ Designated as safety issue: No ]
    Postoperative will be measured at PACU, one week after surgery and at the next postoperative vist (one month) after surgery.
  • Nausea and vomiting will be measured with follow up [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) and a questionnaires at PACU, one week after surgery at PACU, one week, and at the next postoperative vist (one month) after surgery.
  • Constipation (Ileus) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    at PACU and one week after surgery and at the next postoperative vist (one month) after surgery.
  • Constipation (Ileus) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    at PACU, one week, and at the next postoperative vist (one month) after surgery.
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Colorectal Surgery
  • Drug: Placebo
    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
  • Placebo Comparator: Control

    Loading and Infusion:

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

    Interventions:
    • Drug: Ketamine high-dose
    • Drug: Ketamine low-dose
  • Active Comparator: Ketamine low-dose
    Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min
    Interventions:
    • Drug: Placebo
    • Drug: Ketamine high-dose
  • Active Comparator: Ketamine high-dose
    Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
    Interventions:
    • Drug: Placebo
    • Drug: Ketamine low-dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
102
October 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01365195
Pro00024533
No
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Not Provided
Principal Investigator: Roya Yumul, MD PhD Cedars-Sinai Medical Center
Study Director: Roya Yumul, MD., PhD Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP