| CTRI Number |
CTRI/2025/03/081929 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Liver damage after brain operation |
|
Scientific Title of Study
|
Hepatic Injury Following Elective Craniotomy Surgery- A Prospective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surya Kumar Dube |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 709(A), 7th Floor, Neurosciences Center, AIIMS, New Delhi.110029
New Delhi DELHI 110029 India |
| Phone |
9868398208 |
| Fax |
|
| Email |
surya.dube@aiims.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Surya Kumar Dube |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 709(A), 7th Floor, Neurosciences Center, AIIMS, New Delhi.110029
DELHI 110029 India |
| Phone |
9868398208 |
| Fax |
|
| Email |
surya.dube@aiims.edu |
|
Details of Contact Person Public Query
|
| Name |
Surya Kumar Dube |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 709(A), 7th Floor, Neurosciences Center, AIIMS, New Delhi.110029
DELHI 110029 India |
| Phone |
9868398208 |
| Fax |
|
| Email |
surya.dube@aiims.edu |
|
|
Source of Monetary or Material Support
|
| Room No 709(A), 7th Floor, Neurosciences Center, All India Institute of Medical Sciences,
New Delhi
DELHI
110029
India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Surya Kumar Dube |
AIIMS, NEW DELHI |
Room No 709(A), 7th Floor, Department of Neuroanaesthesiology and Neurocritical care, Neurosciences Center New Delhi DELHI |
9868398208
surya.dube@aiims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R160||Hepatomegaly, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of ASA I/II status between 18-60 years of age undergoing craniotomy for elective neurosurgical procedures will be enrolled in this prospective observational study |
|
| ExclusionCriteria |
| Details |
1.Patients younger than 18 yrs or older than 60 yrs.
2.Hemodynamically unstable patients or patients scheduled for emergency surgeries
3.Patients with pre-existing liver dysfunctions
4.Patients with abnormal liver parameters
5.Patients on hepatoxic drugs
6.Patients with pre-existing renal/cardiac dysfunction
7.Pregnancy
8.Hemodynamic instability |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the occurrence of hepatic injury after elective craniotomy surgery |
1.Baseline At Pre-operative period
2.immediate post-op
3.POD-1
4.POD-2
5.POD-3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out various perioperative factors associated with liver injury in elective craniotomy patients |
1.Baseline At Pre-operative period
2.immediate post-op
3.POD-1
4.POD-2
5.POD-3 |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post-operative liver injury refers to the spectrum of abnormal liver biochemical tests. Their occurrence is attributed to surgical positioning, hypotension, or the drugs.1 The assessment of the biochemical parameters such as AST, ALT, and bilirubin indicates the damage to hepatocytes or biliary flow system. The increase in amount of the these parameters from their baseline values help quantify the severity of liver injury into mild, moderate and severe.1 The guidelines on the management of abnormal liver blood tests commissioned by the Clinical Services and Standards Committee (CSSC) of the British Society of Gastroenterology (BSG) recommends that the patients with abnormal liver blood tests should be considered for investigation with a liver etiology screen irrespective of level and duration of abnormality.2The incidence of post operative hepatitis after craniotomy surgeries are unknown. There are few case reports of post-operative hepatitis which was attributed to surgical positioning, and anesthetic agents.3,4 Positions such as prone can lead to hypotension and hypoperfusion to liver tissues leading to hepatic injury. Neurosurgeries are often of long duration and involve surgical position other than supine (prone, lateral, sitting etc.). These factors may contribute towards hepatic injury. However, the data regarding the occurrence of such complications in neurosurgical cases are not robust. Therefore, we are conducting this study to find out the occurrence of hepatic injury after elective craniotomy. Our primary objective is to find out the occurrence of hepatic injury after elective craniotomy surgery. Our Secondary Objective is to find out various perioperative factors associated with liver injury in elective craniotomy patients.
Prior to surgery written and informed consent for the study will be taken from all patients. Pre-operative baseline blood investigations will be sent, which includes hemogram, PT(INR), urea, creatinine, sodium, potassium, calcium, creatinine kinase, transaminase (AST) and alanine transaminase (ALT) Lactate Dehydrogenase (LDH) alkaline phosphatase and serum bilirubin. On the day of surgery all patients will receive their scheduled medications. Standard monitors of ECG, noninvasive blood pressure, and pulse oximeter will be attached and patients will be preoxygenated with 100% oxygen for 3 minutes at a fresh gas flow of 6 lits/ min. General anesthesia will be induced with fentanyl and propofol followed by rocuronium to facilitate tracheal intubation. As per the requirement in the particular case a standard protocol of inhalational/ intravenous anesthesia will be followed in all patients. In the intraoperative period continuous invasive blood pressure, end tidal carbon dioxide (ETCO2), central venous pressure, nasophayngeal temperature, minimum alveolar concentration of inhalational agents will be monitored. The intraoperative hemodynamic parameters will be maintained within 20% of the baseline values and euthermia and euvolemia will be maintained. Arterial blood gas analysis will be done as and when necessary. The total duration of anesthesia and surgery will be noted. Tracheal extubation will be done as per the discretion of the attending anesthesiologist. Serum electrolytes (sodium, potassium and calcium), urea and creatinine, PT(INR), creatinine kinase, AST, ALT, LDH, alkaline phosphatase and serum bilirubin will be measured in after the patient is shifted to the ICU following the surgery. In the post operative period, serum electrolytes, urea, creatinine, PT(INR), creatinine kinase, AST, ALT, LDH, alkaline phosphatase and serum bilirubin will be measured daily till 72 hours after surgery. In the post operative period, patients will be managed as per the standard post operative management protocol in the ICU or ward. The renal injury staging will be done daily from first post operative day till 3 days post operatively using AKIN staging system. Any degree of liver or kidney injury detected during the study period will be managed as appropriate. The total duration of ICU and hospital stay of the patients will be noted. Neurological outcome at discharge will be assessed with Glasgow outcome scale (GOS). |