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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

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.

Condition or disease Intervention/treatment Phase
Colorectal Surgery Drug: Placebo Drug: Ketamine high-dose Drug: Ketamine low-dose Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Intraoperative Ketamine Administration in Colorectal Surgery: Effect on Postoperative Clinical Outcomes
Study Start Date : May 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

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: 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

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
Other Name: Saline Solution

Drug: Ketamine low-dose
Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Participants With Nausea and Vomiting at PACU [ Time Frame: 1 day ]
    Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365195


Locations
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United States, California
Cedars Sinai Medical center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Roya Yumul, MD PhD Cedars-Sinai Medical Center
Study Director: Roya Yumul, MD., PhD Cedars-Sinai Medical Center
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Responsible Party: Roya Yumul, M.D.,PhD., Residency program director, Department of anesthesiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01365195    
Other Study ID Numbers: Pro00024533
First Posted: June 3, 2011    Key Record Dates
Results First Posted: March 2, 2022
Last Update Posted: March 2, 2022
Last Verified: February 2022
Keywords provided by Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center:
opioid
Fentanyl
Anesthetic adjuvant
Pain management
Perioperative outcomes
Constipation
Ileus
Colorectal
Additional relevant MeSH terms:
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Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action