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

NCT03793075 | Unknown

• 1 other identifier: R/18.09.287
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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

Conditions

Major Abdominal Surgery

Outcome Measures

Primary Outcomes (2)

• Serum level of interleukin 6 (IL-6)

  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.

  The time frame extend from 10 minutes before the induction of anesthesia till the first 24 hours postoperative

• Serum level of interleukin IL-1β (IL-1β)

  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.

  The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative

Secondary Outcomes (5)

• Absolute neutrophil count

  The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative

• Total leukocyte count

  The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative

• Neutrophil-lymphocyte ratio (N/L ratio)

  The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative

• Serum Cortisol level

  The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative

• C-reactive protein serum level

  The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative

Study Arms (2)

Propofol group (P)

PLACEBO COMPARATOR

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

Drug: Propofol

Ketamine group ((K)

ACTIVE COMPARATOR

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

Drug: Ketamine

Interventions

Ketamine DRUG

ketamine 5 mcg/kg/min will be used as intravenous anesthetic infusion

Also known as: ketalar

Ketamine group ((K)

Propofol DRUG

propofol 17 mcg /kg/min

Also known as: diprivan

Propofol group (P)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University Hospital: lead

MeSH Terms

Interventions

Ketamine; Propofol

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Officials

• Reem Abdelraouf, lecturer

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reem Abdelraouf, lecturer

CONTACT

01006151100; reemraouf64@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double -blinded ( masking of both participant and care provider)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and surgical intensive care

Model Details: Participating subject will be divided equally and randomly into two groups.The first group is propofol group while the second is the ketamine group

Study Record Dates

• First Submitted: December 30, 2018
• First Posted: January 4, 2019
• Study Start: January 10, 2019
• Primary Completion: June 1, 2019
• Study Completion: August 15, 2019
• Last Updated: January 7, 2019

Record last verified: 2019-01