| 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
|
|
|
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
|
|
|
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. |