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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
  Purpose

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.


Condition Intervention Phase
Colorectal Surgery
Drug: Placebo
Drug: Ketamine high-dose
Drug: Ketamine low-dose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Intraoperative Ketamine Administration in Colorectal Surgery: Effect on Postoperative Clinical Outcomes

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 102
Study Start Date: May 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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
Active Comparator: 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
Drug: Ketamine low-dose
Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365195

Locations
United States, California
Cedars Sinai Medical center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Roya Yumul, M.D.,PhD., Residency program director, Department of anesthesiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01365195     History of Changes
Other Study ID Numbers: Pro00024533
Study First Received: June 1, 2011
Last Updated: September 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
opioid
Fentanyl
Anesthetic adjuvant
Pain management
Perioperative outcomes
Constipation
Ileus
Colorectal

Additional relevant MeSH terms:
Ketamine
Analgesics
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014