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Effect of Ketamine on Postoperative Clinical Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01365195
Recruitment Status : Terminated (recruitment failure)
First Posted : June 3, 2011
Results First Posted : March 2, 2022
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE June 1, 2011
First Posted Date  ICMJE June 3, 2011
Results First Submitted Date  ICMJE January 17, 2022
Results First Posted Date  ICMJE March 2, 2022
Last Update Posted Date March 2, 2022
Study Start Date  ICMJE May 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2022)
Number of Participants With Opioid Consumption [ Time Frame: 1 day ]
Perioperative use of opioid consumption at Post Anesthesia Care Unit (PACU) Data obtained from patient charts
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
Opioid consumption obtained from the recorded data [ Time Frame: 1 month ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2022)
  • Postoperative Pain [ Time Frame: one day ]
    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.
  • Participants With Nausea and Vomiting at PACU [ Time Frame: 1 day ]
    Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
  • Postoperative pain using a Verbal Rating Scale [ Time Frame: one month ]
    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 ]
    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 ]
    at PACU and one week after surgery and at the next postoperative vist (one month) after surgery.
  • Constipation (Ileus) [ Time Frame: 1 month ]
    at PACU, one week, and at the next postoperative vist (one month) after surgery.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Ketamine on Postoperative Clinical Outcomes
Official Title  ICMJE Intraoperative Ketamine Administration in Colorectal Surgery: Effect on Postoperative Clinical Outcomes
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Surgery
Intervention  ICMJE
  • Drug: Placebo
    Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate
    Other Name: Saline Solution
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 8, 2021)
21
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2011)
102
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01365195
Other Study ID Numbers  ICMJE Pro00024533
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roya Yumul, MD PhD Cedars-Sinai Medical Center
Study Director: Roya Yumul, MD., PhD Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date February 2022

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