| CTRI Number |
CTRI/2021/10/037409 [Registered on: 20/10/2021] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Trial to Compare And Study The Effects Of Enhanced Recovery After Surgery (ERAS) Protocol Vs Conventional Care In Patients Undergoing surgery For Brain Aneurysm |
|
Scientific Title of Study
|
Comparison Of Enhanced Recovery After Surgery(ERAS) Protocol Vs Conventional Care In Patients Undergoing Elective Craniotomy For Intracranial Aneurysms: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pandit Sneha Amar |
| Designation |
Senior Resident (DM) |
| Affiliation |
All India Institute Of Medical Sciences,New Delhi |
| Address |
6th floor, Neurosciences Centre, Department of Neuroanaesthesia And Critical Care , All India Institute Of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
8447164004 |
| Fax |
|
| Email |
snehadocuments2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indu Kapoor |
| Designation |
Associate Professor,department of neuroanesthesia and critical care |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
6th floor,Neurosciences Centre, Department of Neuroanaesthesia And Critical Care ,All India Institute Of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9013439134 |
| Fax |
|
| Email |
dr.indu.me@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneha Pandit |
| Designation |
Senior Resident (DM) |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
6th floor,Neurosciences Centre, department of NeuroAnaesthesia and critical care , All india institute of medical sciences, Ansari nagar,new delhi ,delhi,110029
South
DELHI
110029
India |
| Phone |
08447164004 |
| Fax |
|
| Email |
snehadocuments2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
All india institute of medical sciences |
| Address |
6th floor,Department of neuroanesthesia and critical care,neurosciences centre, AIIMS, new delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Pandit Sneha Amar |
All India Institute Of Medical Sciences |
6th floor,Department of Neuroanaesthesia And Critical Care,neurosciences centre, All India Institute Of Medical Sciences, Ansari Nagar, New Delhi,110029
South
DELHI |
8447164004
snehadocuments2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aiims Institutional Ethics Committee,AIIMS room no 102,first floor old OT Block, AIIMS,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I609||Nontraumatic subarachnoid hemorrhage, unspecified, (2) ICD-10 Condition: I671||Cerebral aneurysm, nonruptured, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional care in perioperative period |
This group will be managed as per existing practices at institution. Preoperatively patients will be counselled regarding the risk and benefit of the surgery and for abstinence from both alcohol and smoking when admitted. Patient will be advised for overnight fasting before the surgery. Use of mechanical DVT prophylaxis will be as per discretion of anaesthesiologist and surgical team.
In Intraoperative period, patients will receive antibiotics prophylaxis within 1 hour of skin incision and routine skin preparation. Induction and maintenance of anaesthesia will be according to standard institutional procedure with either TIVA or balanced anaesthesia. intraoperative analgesic management will be taken care by fentanyl infusion 1-2 mcg/kg /hr and boluses as per requirement. Intraoperative fluid management will be done by clinical monitoring. Measures to prevent hypothermia will be implemented with help of Forced air warmers and warm IV fluid infusion.
In postoperative period, patients will receive antiemetic treatment as per requirement if they complaint of nausea or vomiting. Use of mechanical DVT prophylaxis will be as per discretion of anaesthesiologist and surgical team. Decision of restoration of and mobilization diet and urinary catheter removal will be done as per institutional protocol.
|
| Intervention |
ERAS protocol in perioperative period |
Patients will be counselled regarding the risk and benefit of the surgery and for abstinence from both alcohol and smoking when admitted. They will be advised for overnight fasting before the surgery. Mechanical DVT prophylaxis (either with use of graduated compression stockings or intermittent pneumatic compression devices) will be applied, and will bescored according to Apfel PONV risk assessment scale
In Intraoperative period, patients will be receiving mechanical DVT prophylaxis in form of graduated compression stockings or intermittent pneumatic compression devices. They will receive Antibiotics prophylaxis within 1 hour of skin incision and routine skin preparation. Induction and maintenance of anaesthesia will be according to standard institutional procedure with either TIVA or balanced anaesthesia. After induction and before the start of surgery ERAS group will receive complete bilateral Scalp block with 0.25% bupivacaine.Dexmedetomidine drug infusion will be started in dose of 0.2-0.7 mcg/kg/hr in maintenance phase of anaesthesia and Fentanyl boluses 0.5-1mcg/kg will be given as per requirement. Intraoperative fluid management will be done according to Cardiac output Goal directed therapy. Measures to prevent hypothermia will be implemented for with help of Forced air warmers and warm IV fluid infusion.
In Postoperative period, PONV prophylaxis with ondansetron 0.15 mg/kg will be received by patients if PONV risk assessment score ≥ 3 before extubation or antiemetic drugs will be administered to patient if they complaint of nausea and vomiting. Patients will be receiving postoperative mechanical DVT Prophylaxis measures.We will attempt for early urinary catheter removal in ERAS subjects and Patients will be encouraged for early restoration of diet and mobilization.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient who gives Informed Consent
2.Patients with anterior circulation aneurysms with World Federation of Neurosurgical Societies(WFNS) grade 1
3.ASA grade 1 and 2
4.GCS 15/15
|
|
| ExclusionCriteria |
| Details |
1.Patients not giving consent
2.Patients with posterior circulation aneurysm
3.World Federation of Neurosurgical Societies (WFNS) grade 2,3,4 and 5
4.Age less than 18 years and more than 65 years
5.ASA grade 3,4,5
6. Pregnant patients
7. Patient requiring postoperative ventilation
8. History of previous brain surgery
9. Preoperative cognitive dysfunction
10. BMI > 40
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| length of stay in hospital |
at discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Fentanyl consumption
|
In intraoperative period |
| Pain assessment by Numerical Rating Score (NRS) pain score |
In Postoperative period at every 2 hour interval for 24 hours |
| Analgesic requirement |
In Postoperative period at 24 hours |
| Antiemetic requirement in 24 hours |
In Postoperative period at 24 hours |
| Length of ICU stay |
duration of stay in ICU after surgery |
| Functional recovery |
discharge,1 month and 3 months |
| Patient satisfaction score |
discharge |
| postoperative complications both surgical(surgical site infection, intracranial infection, epilepsy, haemorrhage, rebleeding , vasospasm etc) and non-surgical complications (respiratory complications, cardiovascular complications gastrointestinal complications, urinary tract complications, and venous thromboembolism etc ) |
at discharge |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/10/2021 |
| Date of Study Completion (India) |
30/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/06/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
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 randomized control trial, single center study comparing the efficacy of enhanced recovery after surgery (ERAS) protocol vs conventional care in 46 patients who will be undergoing elective craniotomy for intracranial aneurysm that will be conducted in neurosciences centre , All India institute of medical sciences, New Delhi. The primary outcome measures will be length of stay in hospital. Secondary outcomes will be Intraoperative fentanyl consumption, Postoperative pain assessment by Numerical Rating Score (NRS) pain score every 2 hours for 24 hours, Postoperative analgesic requirement in 24 hours, Postoperative antiemetic requirement in 24 hours, Length of ICU stay, Any Complications (surgical and non-surgical) till discharge, Functional recovery at discharge,1month and 3 months and Patient satisfaction score at discharge
|