| CTRI Number |
CTRI/2023/08/056337 [Registered on: 09/08/2023] Trial Registered Prospectively |
| Last Modified On: |
26/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare between the usual anaesthetic technique with enhanced recovery after anaesthesia techniques in patients having surgery under endoscopic guidence through nasal cavity in base of skull surgeries. |
|
Scientific Title of Study
|
Comparison of enhanced recovery after surgery versus conventional anesthesia technique on postoperative recovery in the patients undergoing endoscopic endonasal skull base surgeries : A prospective randomized study. |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shelly |
| Designation |
post doctoral fellow Neuroanaesthesia and Neurocritical Care |
| Affiliation |
AIIMS Hospital |
| Address |
3rd floor, Emeregency block, AIIMS Hospital, Basani Phase II
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9877323078 |
| Fax |
0291-2740741 |
| Email |
Shelly.3110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manbir Kaur |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Hospital |
| Address |
3rd floor, Emeregency block, AIIMS Hospital, Basani Phase II
3rd floor, Emeregency block, AIIMS Hospital, Basani Phase II
Jodhpur
RAJASTHAN
342005
India |
| Phone |
|
| Fax |
|
| Email |
doctor.manbir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shelly |
| Designation |
post doctoral fellow Neuroanaesthesia and Neurocritical Care |
| Affiliation |
AIIMS Hospital |
| Address |
3rd floor, Emeregency block, AIIMS Hospital, Basani Phase II
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9877323078 |
| Fax |
|
| Email |
Shelly.3110@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medial Sciences, Basani phase II, Jodhpur. Rajasthan, 342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medial Sciences |
| Address |
Basani phase II, Jodhpur. Rajasthan, 342005
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shelly |
All India Institute of Medial Sciences |
3rd floor, Emeregency Block,Basani phase II, Jodhpur. Rajasthan, 342005
Jodhpur
RAJASTHAN |
9877323078
Shelly.3110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, JODHPUR, Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Conventional technique |
Enhanced recovery after surgery technique will be compared with Conventional technique for perioperative management to see the effectiveness of one method over the other. |
| Intervention |
Enhanced recovery after surgery ( ERAS ) |
Comparison of ERAS will be done with Conventional technique to see the effectiveness on postoperative recovery of patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1, 2
No consent
Endoscopic endonasal skull base surgeries |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference between quality of postoperative recovery in both groups |
preoperative , 24 hours postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Day of ambulation |
24 hours |
| Duration of Hospital stay |
24 hrs |
| Post operative nausea vomiting |
24 hrs |
| Pain score |
2 hrs to 24 hrs |
| Patient satisfaction score |
24 hrs |
| Postoperative complications |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/08/2023 |
| Date of Study Completion (India) |
01/04/2025 |
| Date of First Enrollment (Global) |
17/08/2023 |
| Date of Study Completion (Global) |
01/04/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
yet to publish |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Enhanced recovery after surgery has proven to be beneficial in patients undergoing various surgical procedures including colorectal, urological, orthopedic, ardiac surgery but role in neurosurgery is relatively new concept. Hence, we plan to conduct this observational study to see effectivenss of ERAS in endoscopic endonasal skull base surgeries to see whether the postoperative outcome improves with ERAS. |