Liver Enzymes After General or Spinal Anesthetic TechniquesNCT03421990
Comparative Study of the Change in Liver Enzymes After General or Spinal Anesthetic Techniques in Patients With Preoperatively Elevated Liver Enzymes.
An observational study of Liver Enzymes After General or Spinal Anesthetic Techniques and In Patients With Preoperatively Elevated Liver Enzymes, run by Cairo University at 2 sites in Egypt.
Trial summary
To assess the changes in liver functions postoperatively in patients with preoperatively elevated liver enzymes. To identify the most appropriate anesthesia technique for patients with preoperatively elevated liver enzymes. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Enzymes After General or Spinal Anesthetic Techniques, In Patients With Preoperatively Elevated Liver Enzymes
- What is being tested?
- General anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Oct 2017to 18 Jan 2018
- How long will I take part?
- 3 Days
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 60 Patients are randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups: 1. Group A(n=30),in which general anesthesia technique is used 2. Group B(n=30),in which regional anesthesia technique is used
Who may be able to join
- Adult healthy ASA I, II patients, both genders, aged 18 - 60 years, with stationary elevated liver enzymes < 2 folds undergoing elective lower abdominal wall or limb surgeries with expected operation time less than 2 hours
Who cannot join
- ASA class III or IV
- Age >60 years or <18 years
- Patients undergoing intraperitoneal and laparoscopic procedures.
- Acute viral hepatitis: inflammation of the liver caused by infection with one of the five hepatitis viruses. In most people, the inflammation begins suddenly and lasts only a few weeks.
- Acute alcoholic hepatitis: is inflammation of the liver due to excessive intake of alcohol. It is usually found in association with fatty liver, an early stage of alcoholic liver disease, and may contribute to the progression of fibrosis, leading to cirrhosis.
- Severe chronic hepatitis: is inflammation of the liver that lasts at least 6 months.
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- Child's C class classification: this score is used to assess the prognosis of chronic liver disease, mainly cirrhosis.
- Severe coagulopathy: a pathological condition that reduces the ability of the blood to coagulate, resulting in uncontrolled bleeding. A platelet count of < 50 x 109 /L will be considered at high risk of increased bleeding.
- Severe extrahepatic complication (Hypoxemia, Acute renal failure…)
- Pregnant, diabetic patients
- Patients having an auto-immune disease
- Patients taking anticoagulant drugs or drugs that cause elevated liver enzymes (non-steroidal anti-inflammatory drugs, antibiotics, antiepileptic drugs, inhibitors of hydroxyl-methyl-glutaryl-coenzyme a reductase (statins), and anti-tuberculosis drugs) were excluded from the study
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Comparative Study of the Change in Liver Enzymes After General or Spinal Anesthetic Techniques in Patients With Preoperatively Elevated Liver Enzymes
- To assess the changes in liver functions postoperatively in patients with preoperatively elevated liver enzymes.
- To identify the most appropriate anesthesia technique for patients with preoperatively elevated liver enzymes.
- To assess the effect of intraoperative event (bleeding, hypoxia, hypotension, prolonged operation) on liver functions in these patients.
Read the detailed description
Surgery and anesthesia are stressful events, thus there is a possibility that liver enzymes and bilirubin may increase postoperatively. Mild elevations of serum aminotransferase, alkaline phosphatase, or bilirubin levels are frequent after surgical procedures, whether performed under general or spinal anesthesia. Anesthesia causes an initial reduction in hepatic arterial blood flow of 35-42% in the first 30 min of induction of anesthesia. During surgery, The liver blood flow returns to baseline. It is possible that either the initial hypoperfusion or reperfusion injury, or both, may contribute to postoperative liver dysfunction when it occurs.
The type of surgery is potentially an important factor of postoperative hepatic dysfunction. Intra-abdominal operations are more likely than extra-abdominal surgeries to cause reflex systemic hypotension and to subsequently reduce hepatic blood flow.This could be due to traction on abdominal viscera. Hypercarbia-induced splanchnic vasoconstriction is also a threat to hepatic perfusion in laparoscopic surgery. Surgeries that result in a large amount of blood loss increase the risk for ischemic hepatic injury, as can intraoperative hypotension.
Liver disease is important to recognize preoperatively because the risk of surgery in patients with advanced disease can be grave.Patients with liver disease are more likely than patients without liver disease to experience hepatic decompensation with anesthesia. Measurement of serum Bilirubin levels is central to the evaluation of hepatobiliary disorders. Liver disease is a challenging condition for the anesthesiologist, However, the risk could be diminished by careful consideration of the patients' condition preoperatively and choosing suitable anesthetic procedure and drugs for these patients.Meanwhile, The effect of performing spinal anesthesia on patients with liver disease has not been investigated properly as most studies excluded patients with preoperatively elevated liver enzymes. Studies on patients undergoing general anesthesia with normal preoperative liver function tests showed a transient increase in the level of AST\& ALT, with a mild increase in postoperative bilirubin levels
- Conditions
- Liver Enzymes After General or Spinal Anesthetic Techniques, In Patients With Preoperatively Elevated Liver Enzymes
- Being tested
- General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaProcedure or surgery
Also called Regional anesthesia
general anesthesia and regional anesthesia techniques are used
| Study group | Role | What they receive |
|---|---|---|
| Group A | General anesthesia technique Receives: Procedure: General anesthesia | |
| Group B | Regional anesthesia technique Receives: Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the pre and postoperative liver enzymes
The pre and 24 hours postoperative AST levels of patients in the general anaesthesia group and spinal anaesthesia group
Measured: 24 hours from the start
Secondary outcomes (2)
Changes in Liver function tests (AST, ALT, total and direct Bilirubin) from the preoperative values to 48 hours postoperative
To determine the changes in Liver function tests (AST, ALT, total and direct Bilirubin) from the preoperative values to 48 hours postoperative
Measured: During Operation and 48 hours postoperative
Intraoperative monitoring and correlation with the change of the liver enzymes postoperative
To monitor the intraoperative vital signs (Blood pressure and Heart rate), the intraoperative blood loss and total fluid consumptions, the total consumptions of the vasopressors, the intraoperative adverse events(severe hypotension, bleeding, blood transfusion, hypoxia, hepatotoxic drugs …) and correlate it to the change of the liver enzymes postoperative
Measured: During Operation and 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start15 Oct 2017
- Primary completion15 Jan 2018
- Study completion18 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Enzymes After General or Spinal Anesthetic TechniquesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Hala Mostafa Gomaa, Norhan Abdelaleem Ali, Shady Abo El ela Ismaiel, Mohamed, Ahmed A., M.D.
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
- Investigators
- Norhan abd Aleem Ali, M.D, Principal investigator, Cairo UniversityShady Abo El ela Ismaiel, Ph.D, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421990
- Sponsor's protocol ID
- N 30-2017/Ms
- Status last verified
- Mar 2018
- First submitted
- 9 Jan 2018
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: * To identify the most appropriate anesthesia technique for HCV +ve patients. * To assess the changes in liver functions \& APRI score preoperative and postoperative in HCV +ve patients. * To assess the effect of intraoperative event (bleeding,hypoxia (bleeding,hypoxia,hypotension,prolonged operation )and postoperative events on liver functions in HCV +ve patients
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Change in Liver Enzymes After General or Spinal Anesthetic Techniques in Patients With Preoperatively Elevated Liver Enzymes
- ClinicalTrials.gov ID
- NCT03421990
- Acronym / sponsor ID
- N 30-2017/Ms
- Conditions
- Liver Enzymes After General or Spinal Anesthetic Techniques, In Patients With Preoperatively Elevated Liver Enzymes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Hala Mostafa Gomaa, Norhan Abdelaleem Ali, Shady Abo El ela Ismaiel, Mohamed, Ahmed A., M.D.
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 5 Feb 2018 (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.
- To assess the changes in liver functions postoperatively in patients with preoperatively elevated liver enzymes.
- To identify the most appropriate anesthesia technique for patients with preoperatively elevated liver enzymes.
- To assess the effect of intraoperative event (bleeding, hypoxia, hypotension, prolonged operation) on liver functions in these patients.
Detailed description
Surgery and anesthesia are stressful events, thus there is a possibility that liver enzymes and bilirubin may increase postoperatively. Mild elevations of serum aminotransferase, alkaline phosphatase, or bilirubin levels are frequent after surgical procedures, whether performed under general or spinal anesthesia. Anesthesia causes an initial reduction in hepatic arterial blood flow of 35-42% in the first 30 min of induction of anesthesia. During surgery, The liver blood flow returns to baseline. It is possible that either the initial hypoperfusion or reperfusion injury, or both, may contribute to postoperative liver dysfunction when it occurs.
The type of surgery is potentially an important factor of postoperative hepatic dysfunction. Intra-abdominal operations are more likely than extra-abdominal surgeries to cause reflex systemic hypotension and to subsequently reduce hepatic blood flow.This could be due to traction on abdominal viscera. Hypercarbia-induced splanchnic vasoconstriction is also a threat to hepatic perfusion in laparoscopic surgery. Surgeries that result in a large amount of blood loss increase the risk for ischemic hepatic injury, as can intraoperative hypotension.
Liver disease is important to recognize preoperatively because the risk of surgery in patients with advanced disease can be grave.Patients with liver disease are more likely than patients without liver disease to experience hepatic decompensation with anesthesia. Measurement of serum Bilirubin levels is central to the evaluation of hepatobiliary disorders. Liver disease is a challenging condition for the anesthesiologist, However, the risk could be diminished by careful consideration of the patients' condition preoperatively and choosing suitable anesthetic procedure and drugs for these patients.Meanwhile, The effect of performing spinal anesthesia on patients with liver disease has not been investigated properly as most studies excluded patients with preoperatively elevated liver enzymes. Studies on patients undergoing general anesthesia with normal preoperative liver function tests showed a transient increase in the level of AST\& ALT, with a mild increase in postoperative bilirubin levels
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: General anesthesiaGeneral anesthesia technique |
| Group B | – | Procedure: General anesthesiaRegional anesthesia technique |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 60 Patients are randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups: 1. Group A(n=30),in which general anesthesia technique is used 2. Group B(n=30),in which regional anesthesia technique is used
Key inclusion criteria (1 listed)
- Adult healthy ASA I, II patients, both genders, aged 18 - 60 years, with stationary elevated liver enzymes < 2 folds undergoing elective lower abdominal wall or limb surgeries with expected operation time less than 2 hours
Key exclusion criteria (12 listed)
- ASA class III or IV
- Age >60 years or <18 years
- Patients undergoing intraperitoneal and laparoscopic procedures.
- Acute viral hepatitis: inflammation of the liver caused by infection with one of the five hepatitis viruses. In most people, the inflammation begins suddenly and lasts only a few weeks.
- Acute alcoholic hepatitis: is inflammation of the liver due to excessive intake of alcohol. It is usually found in association with fatty liver, an early stage of alcoholic liver disease, and may contribute to the progression of fibrosis, leading to cirrhosis.
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 |
|---|---|---|
| General anesthesiaAlso: Regional anesthesiageneral anesthesia and regional anesthesia techniques are used | Procedure or surgery | Group A, Group B |
Primary outcome
Compare the pre and postoperative liver enzymes
Time frame: 24 hours from the start
The pre and 24 hours postoperative AST levels of patients in the general anaesthesia group and spinal anaesthesia group
2 secondary outcomes
Changes in Liver function tests (AST, ALT, total and direct Bilirubin) from the preoperative values to 48 hours postoperative
Time frame: During Operation and 48 hours postoperative
Intraoperative monitoring and correlation with the change of the liver enzymes postoperative
Time frame: During Operation and 48 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Individual participant dataSharing planned: Undecided. * To identify the most appropriate anesthesia technique for HCV +ve patients. * To assess the changes in liver functions \& APRI score preoperative and postoperative in HCV +ve patients. * To assess the effect of intraoperative event (bleeding,hypoxia (bleeding,hypoxia,hypotension,prolonged operation )and postoperative events on liver functions in HCV +ve patients
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.
Norhan abd Aleem Ali, M.D principal investigator
Cairo University
Shady Abo El ela Ismaiel, Ph.D principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Enzymes After General or Spinal Anesthetic Techniques and In Patients With Preoperatively Elevated Liver Enzymes, run by Cairo University at 2 sites in Egypt.
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 1 inclusion and 12 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: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the pre and postoperative liver enzymes (time frame: 24 hours from the start). 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 21 Mar 2018.