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Ketamine Versus Propofol Effect on the Immune-mediatory Response for Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT03793075
Recruitment Status : Unknown
Verified January 2019 by Abdelraouf Elsharkawy, Mansoura University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 4, 2019
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Abdelraouf Elsharkawy, Mansoura University Hospital

Tracking Information
First Submitted Date  ICMJE December 30, 2018
First Posted Date  ICMJE January 4, 2019
Last Update Posted Date January 7, 2019
Estimated Study Start Date  ICMJE January 10, 2019
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2019)
  • Serum level of interleukin 6 (IL-6) [ Time Frame: The time frame extend from 10 minutes before the induction of anesthesia till the first 24 hours postoperative ]
    picogram/milliliter using ELISA techniques .Five measurement points : before the induction of general anesthesia, 30 min after beginning infusion of the anesthetic agent , then 2h, 8h and 24 hours postoperative.
  • Serum level of interleukin IL-1β (IL-1β) [ Time Frame: The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative ]
    picogram/milliliter using ELSA techniques .Five measurement points : before the induction of general anesthesia, 30 min after beginning infusion of the anesthetic agent , then 2h, 8h and 24 hours postoperative.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2019)
  • Absolute neutrophil count [ Time Frame: The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative ]
    Number multiplied by 1000/micro liter,measured before the induction of general anesthesia, 30 min after beginning infusion of the anesthetic agent , then 2h, 8h and 24 hours postoperative.
  • Total leukocyte count [ Time Frame: The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative ]
    Number multiplied by 1000/micro liter ,measured before the induction of general anesthesia, 30 min after beginning infusion of the anesthetic agent , then 2h, 8h and 24 hours postoperative.
  • Neutrophil-lymphocyte ratio (N/L ratio) [ Time Frame: The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative ]
    measured before the induction of general anesthesia, 30 min after beginning infusion of the anesthetic agent , then 2h, 8h and 24 hours postoperative.
  • Serum Cortisol level [ Time Frame: The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative ]
    micro-gram /deciliter by immunoassays techniques.measured before the induction of general anesthesia, 30 min after beginning infusion of the anesthetic agent , then 2h, 8h and 24 hours postoperative.
  • C-reactive protein serum level [ Time Frame: The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative ]
    milgram/liter using ELISA technique. measured before the induction of general anesthesia, 30 min after beginning infusion of the anesthetic agent , then 2h, 8h and 24 hours postoperative.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Versus Propofol Effect on the Immune-mediatory Response for Abdominal Surgery
Official Title  ICMJE Immune-mediatory Response of Intravenous Ketamine Versus Propofol for Major Abdominal Surgeries: a Prospective Randomized Study
Brief Summary

Host systemic responses to vigorous stimuli as trauma, surgical tissue injury, anesthesia and post-operative pain, leads to release a variety of pro-inflammatory cytokines including interleukin-1 (IL-1) and interleukin-6 (IL-6) mainly from monocytes and macrophages Thus, the rise of IL-6 is regarded as an early marker of tissue damage and its rise proportional to the degree of tissue damage .

It has been demonstrated that systemic responses to stress may be modified by the anesthetic technique used . Total intravenous anesthesia (TIVA) especially propofol based greatly suppresses the stress response induced by surgery when compared to inhalation by lowering cortisol levels.

Ketamine has the ability to modulate (modify) inflammation . Even the sub-anesthetic doses of ketamine in animal models were even provided to have an effect on the inflammatory response system in the central nervous system

Detailed Description

The release a variety of pro-inflammatory cytokines including tumor necrosis factor-α (TNF-α), interleukin-1 (IL-1) and interleukin-6 (IL-6) mainly from monocytes and macrophages due to surgical trauma or anesthesia .

IL-6 is constantly found in the peripheral blood and rapidly within few minutes unlike other pro inflammatory mediators. Thus, the rise of IL-6 is regarded as an early marker of tissue damage and IL-6 levels are proportional to the degree of tissue damage . The two major actions of IL-6 are having a key role in regulating stress responses by activating the hypothalamic-pituitary- adrenal (HPA) axis and synthesizing fibrinogen (which is necessary for the acute-phase response) serving as a growth factor for activated B-cells .

While appropriate inflammatory reactions are advantageous and essential for wound healing and host defense against microorganisms, excessive immune responses can be detrimental. The released mediators prompt systemic endocrine, immunological and metabolic responses result in increased pain sensitivity, altered metabolism, hyperthermia and greater secretion of liver acute phase proteins and stress hormones, so yields unstable patient's hemodynamic status

Propofol was documented to have an advantage in terms of inflammatory and immunomodulatory effects through significant effect on TNF-α, IL-6 and IL-10 release .

Ketamine has the ability to modulate (modify) inflammation and this is why it is recommended in patients with sepsis undergoing surgery . This may be possibly related with the variations in TNF-α and nuclear factor-κB expression . Even the sub-anesthetic doses of ketamine in animal models were even provided to have an effect on the inflammatory response system in the central nervous system which is involved in its therapeutic effect on depression (Yang-2 et al., 2013).

This study will be conducted to compare between the intravenous infusion of ketamine against the intravenous infusion of propofol during general anesthesia in patients undergoing major abdominal surgeries.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participating subject will be divided equally and randomly into two groups.The first group is propofol group while the second is the ketamine group
Masking: Double (Participant, Care Provider)
Masking Description:
Double -blinded ( masking of both participant and care provider)
Primary Purpose: Supportive Care
Condition  ICMJE Major Abdominal Surgery
Intervention  ICMJE
  • Drug: Ketamine
    ketamine 5 mcg/kg/min will be used as intravenous anesthetic infusion
    Other Name: ketalar
  • Drug: Propofol
    propofol 17 mcg /kg/min
    Other Name: diprivan
Study Arms  ICMJE
  • Placebo Comparator: Propofol group (P)
    The maintenance of anesthesia , patient will receive sevoflurane 1%-2.5% with intravenous infusion of propofol 17 mcg /kg/min and 0.5 mg/kg fentanyl will be given if the heart rate or mean blood pressure increased by 30 % or more from the basal readings
    Intervention: Drug: Propofol
  • Active Comparator: Ketamine group ((K)
    The maintenance of anesthesia , patient will receive sevoflurane 1%-2.5% with intravenous infusion of ketamine 5 mcg /kg/min and 0.5 mg/kg fentanyl will be given if the heart rate or mean blood pressure increased by 30 % or more from the basal readings
    Intervention: Drug: Ketamine
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 3, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 15, 2019
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Elective major abdominal surgeries with median incision with right or left extension.
  • ASA -physical status I -II
  • aged from 18 till 70 years

Exclusion Criteria:

  • body mass index more than 35 kg/m2,
  • Patients having severe cardiovascular, respiratory, hepatic, renal, Endocrinol disorders, malignant
  • Patients having chronic inflammatory diseases
  • Patients received suppressant drugs in the 6 weeks before surgery.
  • Any known allergy or any contraindications to anesthetic drugs;
  • patient refusal,
  • The usage of anti- emetic drug 24 hours before operation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03793075
Other Study ID Numbers  ICMJE R/18.09.287
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abdelraouf Elsharkawy, Mansoura University Hospital
Study Sponsor  ICMJE Mansoura University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Reem Abdelraouf, lecturer Mansoura University
PRS Account Mansoura University Hospital
Verification Date January 2019

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