Comparative Study of the Change in Liver Enzymes After General or Spinal Anesthetic Techniques in Patients With Preoperatively Elevated Liver Enzymes.

In Patients With Preoperatively Elevated Liver Enzymes Clinical Trial

Official title:

Comparative Study of the Change in Liver Enzymes After General or Spinal Anesthetic Techniques in Patients With Preoperatively Elevated Liver Enzymes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03421990
• Other study ID #: N 30-2017/Ms
• Status: Completed
• First received: January 9, 2018
• Last updated: March 20, 2018
• Start date: October 15, 2017
• Est. completion date: January 18, 2018

Study information

• Verified date: March 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

• To assess the effect of intraoperative event (bleeding, hypoxia, hypotension, prolonged operation) on liver functions in these patients.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 18, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• In Patients With Preoperatively Elevated Liver Enzymes
• Liver Enzymes After General or Spinal Anesthetic Techniques

Intervention

Procedure:
• General anesthesia
general anesthesia and regional anesthesia techniques are used

Locations

Country	Name	City	State
Egypt	Ahmed Abdalla	Cairo
Egypt	Ahmed Abdalla Mohamed	Cairo

Sponsors (5)

Lead Sponsor	Collaborator
Cairo University	Ahmed Abdalla Mohamed, Hala Mostafa Gomaa, Norhan Abdelaleem Ali, Shady Abo El ela Ismaiel

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours from the start
Secondary	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	During Operation and 48 hours postoperative
Secondary	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	During Operation and 48 hours postoperative