FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/062398 [Registered on: 07/02/2024] Trial Registered Prospectively
Last Modified On: 21/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   All patients undergoing surgery in the small brain area will be given general anesthesia (putting them to sleep). After you are asleep, your breathing, heart, brain and kidney function will be monitored by an anesthesiologist.  
Scientific Title of Study   Modified Surgical Apgar Score for predicting the postoperative outcome following infratentorial tumour surgery– A prospective observational cohort 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  Dr Ramamani Mariappan 
Designation  Professor, Department of Neuroanaesthesia 
Affiliation  Christian Medical College 
Address  Room No. A601 Neuroanesthesia office 6th floor Ranipet campus Christian Medical College, Vellore

Vellore
TAMIL NADU
632517
India 
Phone  9443753184  
Fax    
Email  ramamani@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramamani Mariappan 
Designation  Professor, Department of Neuroanaesthesia 
Affiliation  Christian Medical College 
Address  Room no. A601 Neuroanesthesia office 6th floor Ranipet campus Christian Medical College, Vellore

Vellore
TAMIL NADU
632517
India 
Phone  9443753184  
Fax    
Email  ramamani@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Ramamani Mariappan 
Designation  Professor, Department of Neuroanaesthesia 
Affiliation  Christian Medical College 
Address  Room no. A601 Neuroanesthesia office 6th floor Ranipet Campus Christian Medical College, Vellore

Vellore
TAMIL NADU
632517
India 
Phone  9443753184  
Fax    
Email  ramamani@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Christian Medical College, Vellore 
 
Primary Sponsor  
Name  Christian Medical College 
Address  Vellore, Tamil Nadu 632517 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahesh Kumar  Neurosurgery Operation theater  Department- Neurosurgery DIVISION - B block OR NO. 1-5 4TH FLOOR RANIPET CAMPUS CHRISTIAN MEDICAL COLLEGE
Vellore
TAMIL NADU 
7042293980

mahesh.kumar@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board Christian Medical College, Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G00-G99||Diseases of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients undergoing elective infratentorial brain tumour surgery. 
 
ExclusionCriteria 
Details  Patients who are hypertensive on beta blockers, and those who have uncontrolled
heart rate due to atrial fibrillation.
Posterior fossa craniotomy for non-tumour cases. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The utility of Modified Surgical Apgar score to predict the early postoperative morbidity, including cardiovascular, respiratory, and neurological morbidity following infratentorial tumour surgery.  Intraoperative and Postoperative period 
 
Secondary Outcome  
Outcome  TimePoints 
The utility of Modified Surgical Apgar score to predict 28-day
mortality following infratentorial tumour surgery 
28 days post surgery 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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)   12/02/2024 
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  
Patients undergoing posterior fossa tumour surgery are prone to blood pressure (BP) and heart rate (HR) changes (haemodynamic variation) such as hypertension, hypotension, bradycardia or tachycardia, arrhythmias due to dissection of tumour from vital structures such as the brainstem, and cranial nerves especially 5th (sympathetic response) and 10th (parasympathetic) cranial nerves. Traction on the tumour during the cerebellopontine angle tumour resection, excision of brainstem tumour and tumour excision arising from cranial nerves (5th cranial nerve) can cause haemodynamic changes due to traction on the brainstem which can later lead to brainstem oedema, contusion or haematoma. All these can worsen the neurological outcome and can cause mortality. Cranial nerve manipulation and injuries cause either transient or permanent neurological deficits, which increases postoperative morbidity and mortality.
The Surgical Apgar score (SAS) is a score derived from intraoperative BP and HR changes and blood loss that has been validated to predict early postoperative outcomes in the general surgical and vascular surgical population. We are planning to modify the Surgical Apgar score and see whether the modified score predicts the early postoperative outcome, which includes morbidity and mortality in an adult patient undergoing a posterior fossa craniotomy and excision of the infratentorial tumour. (Both SAS and Modified Surgical Apgar score (MSAS) are explained below) Intraoperatively, the haemodynamics (HR and Blood pressure) from the time of induction of anaesthesia to extubation or the time of transfer to NICU (in cases where elective ventilation is planned) will be recorded. These parameters will be taken from the anaesthesia monitors, where the data is stored automatically every minute.
The intraoperative period will be divided into 4 phases, phase 1-Pretumour resection- this is taken from the time of induction to dural opening. Phase 2- tumour resection –is the time period taken from the time of start to completion of tumour excision/beginning of achieving hemostasis, Phase 3- Hemostasis and surgical closure – which include the time from completion of hemostasis to skull pin removal (this is the phase anaesthesiologist will bring up the blood pressure to baseline using vasopressor such as phenylephrine or ephedrine or increasing the dose of noradrenaline dose), Phase 4 – extubation – after the removal of skull pin to extubation. Haemodynamic changes during Phase 2 and Phase 4 can increase perioperative morbidity and mortality. The minimum and maximum heart rate and minimum and maximum mean blood pressure (MBP) will be recorded during these four phases of surgery, and we will calculate the Modified Surgical Apgar score for each of the 4 phases, we will also calculate the Modified Surgical Apgar Score combining all the four phases. (From induction to extubation). Haemodynamics (Heart rate and blood pressure) will be recorded in the datasheet by the attending anaesthesiologist. At the end of each phase, stored data f 
Close