Clinical trial NCT03421990: Comparative Study of the Change in Liver Enzymes After General or Spinal Anesthetic Techniques in Patients With Preoperatively Elevated Liver Enzymes.
Official title: Comparative Study of the Change in Liver Enzymes After General or Spinal Anesthetic Techniques in Patients With Preoperatively Elevated Liver Enzymes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Enzymes After General or Spinal Anesthetic Techniques
In Patients With Preoperatively Elevated Liver Enzymes
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Hala Mostafa Gomaa
name: Norhan Abdelaleem Ali
name: Shady Abo El ela Ismaiel
name: Mohamed, Ahmed A., M.D.
First posted: 2018-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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.
* 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Compare the pre and postoperative liver enzymes
timeFrame: 24 hours from the start
Secondary outcomes:
measure: Changes in Liver function tests (AST, ALT, total and direct Bilirubin) from the preoperative values to 48 hours postoperative
timeFrame: During Operation and 48 hours postoperative
measure: Intraoperative monitoring and correlation with the change of the liver enzymes postoperative
timeFrame: During Operation and 48 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abdalla Mohamed
city: Cairo
country: Egypt
facility: Ahmed Abdalla
Study officials:
affiliation: Cairo University
name: Norhan abd Aleem Ali, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Shady Abo El ela Ismaiel, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: