NCT03421990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2018

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

January 9, 2018

Last Update Submit

March 20, 2018

Conditions

Liver Enzymes After General or Spinal Anesthetic TechniquesIn Patients With Preoperatively Elevated Liver Enzymes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

    During Operation and 48 hours postoperative

Study Arms (2)

Group A

General anesthesia technique

Procedure: General anesthesia

Group B

Regional anesthesia technique

Procedure: General anesthesia

Interventions

General anesthesiaPROCEDURE

general anesthesia and regional anesthesia techniques are used

Also known as: Regional anesthesia
Group AGroup B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

Ahmed Abdalla

Cairo, 11451, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Samples Liver Enzymes measurments

MeSH Terms

Interventions

Anesthesia, GeneralAnesthesia, Conduction

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Norhan abd Aleem Ali, M.D

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Shady Abo El ela Ismaiel, Ph.D

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia&I.C.U and Pain Clinic

Study Record Dates

First Submitted

January 9, 2018

First Posted

February 5, 2018

Study Start

October 15, 2017

Primary Completion

January 15, 2018

Study Completion

January 18, 2018

Last Updated

March 21, 2018

Record last verified: 2018-03

Locations

EG(2)