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Comparison of CRP Levels, Neutrophil Count, and Clinical Outcomes of Low Dose Ketamine Between at Anesthesia Induction and at the End of Surgery in Patients Undergo Elective Laparotomy (PRO-Ketamine)

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ClinicalTrials.gov Identifier: NCT04462094
Recruitment Status : Completed
First Posted : July 8, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Christopher Ryalino, Udayana University

Tracking Information
First Submitted Date  ICMJE June 26, 2020
First Posted Date  ICMJE July 8, 2020
Last Update Posted Date November 12, 2020
Actual Study Start Date  ICMJE July 27, 2020
Actual Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2020)
  • Serum CRP level [ Time Frame: 1-hour before surgery ]
    Serum C-reactive protein level
  • Serum CRP level [ Time Frame: 24-hours after surgery ]
    Serum C-reactive protein level
  • serum neutrophil-count [ Time Frame: 1-hour before surgery ]
    serum neutrophil-count (from a complete blood count test)
  • serum neutrophil-count [ Time Frame: 24-hours after surgery ]
    serum neutrophil-count (from a complete blood count test)
  • VAS (visual analog score) [ Time Frame: first 24 hours after the surgery ]
    minimum=0; maximum=10; higher score corresponds to more severe pain
  • morphine consumption (mg) [ Time Frame: first 24 hours after the surgery ]
    total morphine consumption in 24 hours after the surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of CRP Levels, Neutrophil Count, and Clinical Outcomes of Low Dose Ketamine Between at Anesthesia Induction and at the End of Surgery in Patients Undergo Elective Laparotomy
Official Title  ICMJE Comparison of CRP Levels, Neutrophil Count, and Clinical Outcomes of Low Dose Ketamine Between at Anesthesia Induction and at the End of Surgery in Patients Undergo Elective Laparotomy
Brief Summary The effects of anesthesia and surgery can lead to stress responses that result in hormonal and metabolic changes in the body. The immune system and the nervous system communicate both ways, and it was found that nociception and proinflammatory cytokines play a joint regulatory role, i.e., increased production of proinflammatory cytokines can worsen the pain. Major surgery can trigger the release of cytokines such as IL-1, IL-6, and TNF-α.
Detailed Description

The effects of anesthesia and surgery can lead to stress responses that result in hormonal and metabolic changes in the body. The immune system and the nervous system communicate both ways, and it was found that nociception and proinflammatory cytokines play a joint regulatory role, i.e., increased production of proinflammatory cytokines can worsen the pain. Major surgery can trigger the release of cytokines such as IL-1, IL-6, and TNF-α.

The acute analgesic effect of ketamine is generally believed to be mediated through the blockade of the phencyclidine binding site of the N-methyl-d-aspartate (NMDA) receptor of nociceptive neurons. Ketamine can reduce the inflammatory response marked by a decrease in CRP levels to surgical trauma and can prevent secondary damage to tissues/organs that were not initially affected by surgery by reducing inflammation. This also reduces postoperative pain and analgesics.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a double-blind, randomized control trial. It provides a controlled care comparison between low-dose ketamine given at anesthesia induction and at the end-of-surgery.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Only care providers involved directly with the subjects in the operating room are not masked.
Primary Purpose: Supportive Care
Condition  ICMJE
  • General Anesthesia
  • Laparotomy
  • Inflammation
Intervention  ICMJE
  • Drug: Ketamine 0.3 mg/kg at end-of-surgery
    Ketamine 0.3 mg/kg at end-of-surgery (intravenously)
    Other Name: Group E
  • Drug: Ketamine 0.3 mg/kg at anesthesia induction
    Ketamine 0.3 mg/kg at anesthesia induction (intravenously)
    Other Name: Group I
Study Arms  ICMJE
  • Active Comparator: End-of-surgery
    Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at the end of surgery
    Interventions:
    • Drug: Ketamine 0.3 mg/kg at end-of-surgery
    • Drug: Ketamine 0.3 mg/kg at anesthesia induction
  • Placebo Comparator: Induction
    Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at induction
    Interventions:
    • Drug: Ketamine 0.3 mg/kg at end-of-surgery
    • Drug: Ketamine 0.3 mg/kg at anesthesia induction
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 Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2020)
68
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 10, 2020
Actual Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients undergoing elective laparotomy with general anesthesia at Sanglah Hospital from July to September 2020.
  2. Patients aged 18-65 years.
  3. Patient physical status American American Society of Anesthesiologist (ASA) 1 and 2.

Exclusion Criteria:

  1. Contraindication to ketamine.
  2. Allergy to morphine
  3. Presence of cardiorespiratory chronic diseases.
  4. Presence of autoimmune diseases.
  5. History of the central nervous system or psychiatric disorders.
  6. BMI <18.5 kg/m2 or ≥30 kg/m2.
  7. A history of chronic pain killer medications (such as opioid or non-steroidal anti- inflammatory drugs)

Drop Out Criteria

  1. Patients with class 3 bleeding during the surgery
  2. Patients with more than 5-hours duration of surgery
  3. Patients need mechanical ventilation after the surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 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 Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04462094
Other Study ID Numbers  ICMJE UNUD-CTR-FK260620-002
1143/UN14.2.2.VII.14/LT/2020 ( Other Identifier: Committee of Ethical Research of Udayana University )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christopher Ryalino, Udayana University
Study Sponsor  ICMJE Udayana University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Tjokorda GA Senapathi, Dr Udayana University
Principal Investigator: Christopher Ryalino, Dr Udayana University
Study Director: Made SP Adi, Dr Udayana University
PRS Account Udayana University
Verification Date November 2020

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