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PRO-Ketamine: 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

Sponsor
Udayana University (Other)
Overall Status
Completed
CT.gov ID
NCT04462094
Collaborator
(none)
68
Enrollment
1
Location
2
Arms
3.5
Actual Duration (Months)
19.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ketamine 0.3 mg/kg at end-of-surgery
  • Drug: Ketamine 0.3 mg/kg at anesthesia induction
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
68 participants
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.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
Official Title:
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
Actual Study Start Date :
Jul 27, 2020
Actual Primary Completion Date :
Sep 30, 2020
Actual Study Completion Date :
Nov 10, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: End-of-surgery

Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at the end of surgery

Drug: Ketamine 0.3 mg/kg at end-of-surgery
Ketamine 0.3 mg/kg at end-of-surgery (intravenously)
Other Names:
  • Group E

    • Drug: Ketamine 0.3 mg/kg at anesthesia induction
    Ketamine 0.3 mg/kg at anesthesia induction (intravenously)
    Other Names:
  • Group I

    		•
    Placebo Comparator: Induction

    Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at induction

    Drug: Ketamine 0.3 mg/kg at end-of-surgery
    Ketamine 0.3 mg/kg at end-of-surgery (intravenously)
    Other Names:
  • Group E

    • Drug: Ketamine 0.3 mg/kg at anesthesia induction
    Ketamine 0.3 mg/kg at anesthesia induction (intravenously)
    Other Names:
  • Group I

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum CRP level [1-hour before surgery]

      Serum C-reactive protein level

    2. Serum CRP level [24-hours after surgery]

      Serum C-reactive protein level

    3. serum neutrophil-count [1-hour before surgery]

      serum neutrophil-count (from a complete blood count test)

    4. serum neutrophil-count [24-hours after surgery]

      serum neutrophil-count (from a complete blood count test)

    5. VAS (visual analog score) [first 24 hours after the surgery]

      minimum=0; maximum=10; higher score corresponds to more severe pain

    6. morphine consumption (mg) [first 24 hours after the surgery]

      total morphine consumption in 24 hours after the surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sanglah General Hospital Denpasar Bali Indonesia 80114

    Sponsors and Collaborators

    • Udayana University

    Investigators

    • Study Chair: Tjokorda GA Senapathi, Dr, Udayana University
    • Principal Investigator: Christopher Ryalino, Dr, Udayana University
    • Study Director: Made SP Adi, Dr, Udayana University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christopher Ryalino, Principal Investigator, Udayana University
    ClinicalTrials.gov Identifier:
    NCT04462094
    Other Study ID Numbers:
    • UNUD-CTR-FK260620-002
    • 1143/UN14.2.2.VII.14/LT/2020
    First Posted:
    Jul 8, 2020
    Last Update Posted:
    Nov 12, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Christopher Ryalino, Principal Investigator, Udayana University
    stress response
    infammation
    general anesthesia
    Additional relevant MeSH terms:
    Inflammation
    Ketamine

    Study Results

    No Results Posted as of Nov 12, 2020