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

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.

Study Overview

• Status: Completed
• Conditions: Liver Enzymes After General or Spinal Anesthetic Techniques; In Patients With Preoperatively Elevated Liver Enzymes
• Intervention / Treatment: Procedure: General anesthesia

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Ahmed Abdalla Mohamed
  • Cairo, Egypt, 11451
    • Ahmed Abdalla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; General anesthesia technique	Procedure: General anesthesia; general anesthesia and regional anesthesia techniques are used; Other Names: Regional anesthesia
Group B; Regional anesthesia technique	Procedure: General anesthesia; general anesthesia and regional anesthesia techniques are used; Other Names: Regional anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Mohamed, Ahmed A., M.D.; Norhan Abdelaleem Ali; Hala Mostafa Gomaa; Shady Abo El ela Ismaiel
• Investigators: Principal Investigator: Norhan abd Aleem Ali, M.D, Cairo University; Principal Investigator: Shady Abo El ela Ismaiel, Ph.D, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2017
• Primary Completion (Actual): January 15, 2018
• Study Completion (Actual): January 18, 2018

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: N 30-2017/Ms

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No