| CTRI Number |
CTRI/2025/01/079197 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Time to awaken from anaesthesia (emergence time) following target-controlled (automatically by machine) vs manual controlled (by anaesthesiologist) infusion of propofol in patients undergoing endoscopic trans-sphenoidal (nasal approach) pituitary surgery: A Prospective, Randomized, Controlled study |
|
Scientific Title of Study
|
Emergence time following target-controlled versus manual controlled propofol
infusion in patients undergoing endoscopic trans-sphenoidal pituitary surgery: A
Prospective, Randomized, Controlled 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 SANIYA JAISWAL |
| Designation |
Senior Resident (DM) |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 709-A, 7th floor, Department of Neuroanaesthesiology and Critical Care, Neurosciences, Centre, AIIMS, New Delhi.
Department of Neuroanaesthesiology and Critical Care, Neurosciences, Centre, AIIMS, New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
06263851418 |
| Fax |
|
| Email |
jsoni453@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra Singh Chouhan |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 6, 6th floor, Department of Neuroanaesthesiology and Critical Care, Neurosciences, Centre, AIIMS, New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
9999069041 |
| Fax |
|
| Email |
drrajendrasinghchouhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajendra Singh Chouhan |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 6, 6th floor, Department of Neuroanaesthesiology and Critical Care, Neurosciences, Centre, AIIMS, New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
9999069041 |
| Fax |
|
| Email |
drrajendrasinghchouhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi
Ansari Nagar , New Delhi, India, 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
AIIMS, Ansari Nagar, New Delhi-110029. |
| 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 |
| DrSaniya Jaiswal |
AIIMS New Delhi |
Room No 709A Department of Neuroanaesthesiology and Critical Care
Neurosciences Centre
AIIMS New Delhi
New Delhi
DELHI |
6263851418
jsoni453@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D3A8||Other benign neuroendocrine tumors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Manual controlled infusion |
Propofol will be administered by Manual controlled infusion (MCI) pump in the Comparator group.
Total duration- 18months |
| Intervention |
Target controlled infusion |
Propofol will be administered by Target controlled infusion (TCI) pump in the intervention group.
Total duration- 18months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective endoscopic trans-sphenoidal pituitary tumour surgery, ASA physical Grade I & II |
|
| ExclusionCriteria |
| Details |
Refusal for consent, Emergency Surgery, Giant pituitary tumor more than 4cm, Tumors with major cavernous sinus infiltration and ICA encasement, Altered sensorium, Body Mass Index more than 35, Obstructive sleep apnoea, Psychiatric or psychological disorder, Anticipated difficult airway, History of any intracranial surgery in the past, Patients with Alcohol or substance abuse, Pregnant or lactating patient will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to respond to verbal commands following cessation of anaesthetic drug infusion. |
From nasal packing to tracheal extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamics variability
Total consumption of propofol & fentanyl
Time to tracheal extubation
Aldretes scores. |
Hemodynamics variability at baselines & every 15 minutes intraoperatively.
Total consumption of propofol & fentanyl intraoperatively.
Time to tracheal extubation at the end of surgery.
Aldretes scores at 5 min after tracheal extubation.
|
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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="1"
Months="6"
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
|
Smooth and early emergence from anaesthesia prevents sudden rise in blood pressure and risk of complications such as bleeding while early recovery facilitates prompt neurological assessment and treatment of complications. This study aims to compare the emergence time (from anaesthesia) between the target-controlled infusion (TCI) versus manual-controlled infusion (MCI) techniques of propofol infusion in patients undergoing elective endoscopic trans-sphenoidal pituitary surgery. The study will also asses the intraoperative hemodynamic variability, propofol and fentanyl consumption, time to tracheal extubation and aldretes’s score at 5 min between the two groups. The present study will provide insight whether use of target controlled infusion technique for propofol infusion will result in early and smooth recovery from anaesthesia over manual controlled technique in patients undergoing elective endoscopic trans-sphenoidal pituitary surgery.
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