Major Abdominal SurgeryNCT03793075
Ketamine Versus Propofol Effect on the Immune-mediatory Response for Abdominal Surgery
A study testing Ketamine and Propofol in people with Major Abdominal Surgery, run by Mansoura University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Abdominal Surgery
- What is being tested?
- Ketamine and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2019to 15 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective major abdominal surgeries with median incision with right or left extension.
- ASA -physical status I -II
- aged from 18 till 70 years
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Immune-mediatory Response of Intravenous Ketamine Versus Propofol for Major Abdominal Surgeries: a Prospective Randomized Study
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
Read the 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.
- Conditions
- Major Abdominal Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called ketalar
ketamine 5 mcg/kg/min will be used as intravenous anesthetic infusion
PropofolDrug
Also called diprivan
propofol 17 mcg /kg/min
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative
Secondary outcomes (5)
Absolute neutrophil count
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.
Measured: The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative
Total leukocyte count
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.
Measured: The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative
Neutrophil-lymphocyte ratio (N/L ratio)
measured before the induction of general anesthesia, 30 min after beginning infusion of the anesthetic agent , then 2h, 8h and 24 hours postoperative.
Measured: The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative
Serum Cortisol level
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.
Measured: The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative
C-reactive protein serum level
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.
Measured: The time frame extend from 10 minutes before induction of anesthesia till the first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start10 Jan 2019 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion15 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelraouf Elsharkawy, Mansoura University Hospital
- Investigators
- Reem Abdelraouf, lecturer, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793075
- Sponsor's protocol ID
- R/18.09.287
- Status last verified
- Jan 2019
- First submitted
- 30 Dec 2018
- Last updated
- 7 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune-mediatory Response of Intravenous Ketamine Versus Propofol for Major Abdominal Surgeries: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03793075
- Acronym / sponsor ID
- R/18.09.287
- Conditions
- Major Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 10 Jan 2019 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 15 Aug 2019 (estimated)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Propofol group (P) | Placebo comparator | Drug: PropofolThe 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 |
| Ketamine group ((K) | Active comparator | Drug: KetamineThe 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective major abdominal surgeries with median incision with right or left extension.
- ASA -physical status I -II
- aged from 18 till 70 years
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: ketalarketamine 5 mcg/kg/min will be used as intravenous anesthetic infusion | Drug | Ketamine group ((K) |
| PropofolAlso: diprivanpropofol 17 mcg /kg/min | Drug | Propofol group (P) |
Primary outcome
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.
5 secondary outcomes
Absolute neutrophil count
Time frame: The time frame extend from 10 minutes before induction of anesthesia till the first 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
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
Serum Cortisol level
Time frame: The time frame extend from 10 minutes before induction of anesthesia till the first 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reem Abdelraouf, lecturer principal investigator
Mansoura University
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine and Propofol in people with Major Abdominal Surgery, run by Mansoura University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reem Abdelraouf, lecturer (01006151100, reemraouf64@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.