FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092326 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 03/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE OBSERVATINAL STUDY 
Study Design  Other 
Public Title of Study   Factors affecting immediate extubation in the operating room after lower abdominal oncological surgeries. 
Scientific Title of Study   Factors affecting immediate extubation in the operating room after robotic lower abdominal oncological surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sinchana H P 
Designation  Postgraduate resident 
Affiliation  Kidwai memorial institute of oncology 
Address  101 Shanthidhama,Kidwai memorial institute of oncology, Hombegowdanagar, Bangalore-560029

Bangalore
KARNATAKA
560029
India 
Phone  9611851791  
Fax    
Email  sinchanaprabhakar@68gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kavitha Lakshman 
Designation  Associate professor 
Affiliation  Kidwai memorial institute of oncology 
Address  105 Ground floor,OT block,Kidwai memorial institute of oncology, Hombegowdanagar,Bangalore-560029

Bangalore
KARNATAKA
560029
India 
Phone  9480333357  
Fax    
Email  drkavithalakshman@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kavitha Lakshman 
Designation  Associate professor 
Affiliation  Kidwai memorial institute of oncology 
Address  105 Ground floor ,OT block,Kidwai memorial institute of oncology, Hombegowdanagar,Bangalore-560029

Bangalore
KARNATAKA
560029
India 
Phone  9480333357  
Fax    
Email  drkavithalakshman@gmail.com  
 
Source of Monetary or Material Support  
Kidwai memorial institute of oncology, Hombegowdanagar, Bangalore-560029 , India 
 
Primary Sponsor  
Name  Dr Sinchana H P 
Address  101, Shanthidhama ,Kidwai memorial institute of oncology, Bangalore-560029, India 
Type of Sponsor  Other [SELF] 
 
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 Sinchana H P  Kidwai memorial institute of oncology  DEPARTMENT OF ANAESTHESIOLOGY AND PAIN RELIEF,OT BLOCK,DR M H MARIGOWDA ROAD,BANGALORE-560029
Bangalore
KARNATAKA 
9611851791

sinchanaprabhakar@68gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MEDICAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C20||Malignant neoplasm of rectum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients undergoing robotic lower abdominal oncological surgery
2.Patients willing to give informed consent
3.Indivisuals of age between 18 to 60 years
4.ASA grade I and II patients 
 
ExclusionCriteria 
Details  1.Patient refusal
2.Patients with raised intracranial pressure and intraocular pressure
3.Patients with restrictive and obstructive lung disease
4.Patients with h/o IHD 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To assess the optic nerve sheath diameter as a determinant for extubation in robotic lower abdominal oncological surgeries  3-4 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the degree of Trendelenburg, duration of Trendelenburg, duration of surgery,peak airway pressure as determinants for extubation in robotic lower abdominal oncological surgeries  3-4 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/09/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

This study is a Prospective observational study for factors affecting immediate extubation in the operating room after lower abdominal oncological surgeries.Optic nerve sheath diameter is assessed with ultrasound guidance using a high frequency linear probe. ONSD is is a reliable method as a surrogate parameter of intracranial pressure during the perioperative period.The first measurement is taken 5 minutes after intubation in neutral position. Subsequent measurements will be taken at 30 minutes after placing in Trendelenburg position and after achieving pneumoperitoneum  and just before the termination of pneumoperitoneum. The last measurement is taken 10 minutes after termination of pneumoperitoneum. 

Parameters like the degree of Trendelenburg position will be noted using protractor, peak airway pressure will be noted half hourly starting from baseline, immediately after intubation, total IV fluids used will be noted. Duration of Trendelenburg position and duration of pneumoperitoneum will be noted.Intra abdominal pressure will be noted.

At the end of the surgery the pneumoperitoneum will be terminated and the patients are moved from the Trendelenburg position to neutral position. Immediate extubation is attempted if the standard criteria for extubation are met.  If extubation could not be done within 20 mins, patient will be shifted to ICU for further management.

 
Close