| CTRI Number |
CTRI/2023/06/053603 [Registered on: 07/06/2023] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Influence of dexmedetomidine drug in scalp(head) block with ropivacaine drug 0.25% for obtaining effect of nociceptive(pain) and haemodynamic responses to skull pin placement in neurosurgical patients undergoing craniotomy surgery. |
|
Scientific Title of Study
|
Influence of dexmeditomidine in scalp block with
ropivacaine 0.25% for attenuation of nociceptive and haemodynamic responses to skull pin placement in neurosurgical patients undergoing craniotomy:A prospective randomized comparative study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nitesh Dahiya |
| Designation |
Resident doctor,depatment of anaesthesia |
| Affiliation |
mahatma gandhi medical college and hospital,jaipur. |
| Address |
room no-312-hostel 4C,sabarmati hostel,mahatma gandhi medical college,jaipur.
room no-C22-unique new town,jagatpura,jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
7728878456 |
| Fax |
|
| Email |
ndnitesh99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr prachi verma |
| Designation |
Associate professor ,department of anaesthesia |
| Affiliation |
mahatma gandhi medical college,jaipur. |
| Address |
dept of anaesthesia,Mahatma Gandhi medical college and hospital, sitapura,jaipur
dept of anaesthesia,Mahatma Gandhi medical college and hospital, sitapura,jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829191038 |
| Fax |
|
| Email |
Doctorprachi.verma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitesh Dahiya |
| Designation |
Resident doctor ,department of anaesthesia |
| Affiliation |
mahatma gandhi medical college and hospital,jaipur. |
| Address |
312-hostel 4C,sabarmati hostel,mahatma gandhi medical college,jaipur.
room no-C22-unique new town,jagatpura,jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
7728878456 |
| Fax |
|
| Email |
ndnitesh99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi medical college and hospital, sitapura,jaipur (rajasthan) |
|
|
Primary Sponsor
|
| Name |
mahatma gandhi hospital and medical college |
| Address |
Department of Anesthesia Critical care,mahatma gandhi hospital,sitapura,jaipur,rajasthan. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| mahatma gandhi hospital medical college |
Department of Anesthesia Critical care,mahatma gandhi hospital,sitapura,jaipur,rajasthan. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nitesh Dahiya |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIA,OT COMPLEX,jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
7728878456
ndnitesh99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR RAJENDRA KUMAR SUREKHA,MEMBER SECRETARY,IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (2) ICD-10 Condition: R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems, (3) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Scalp block for skull pin placement in craniotomy |
Group B-0.25% ropivacaine+dexmeditomidine
Intraoperativevely starting frome pre surgical baseline values to time interval of 5-15 mins followed by half an hour. |
| Intervention |
scalp block for skull pin placement in craniotomy. |
Group A-ropivacaine o.25%
Intraoperativevely starting frome pre surgical baseline values to time interval of 5-15 mins followed by half an hour. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age:18-65
ASA 1 & 2
Scheduled for elective neurosurgical procedures.
Agreed for written & informed consent.
Requiring mayfield skull pin holder. |
|
| ExclusionCriteria |
| Details |
Uncontrolled hypertensive patients.
Pre operative bradycardia.
Ischemic heart disease.
Cardiac arrhythmia.
Hepatic and renal disease.
Allergy to study drugs.
Past history of craniotomy.
Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyse and compare the change in HR,using lead II of ECG,systolic bp,diastolic BP at different time points after skull pin placement from baseline in both the groups using invasive blood pressure monitoring. |
15 minutes from baseline to 1 hour,
then half an hour till 4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of the study will be on intraoperatively hemodynamic monitoring including blood pressure, MAP,HR and SPO2. |
5 Min observation till 15 mins,then 15 mins observation till 1 hour,then half n hour observation for 4 hours. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2023 |
| Date of Study Completion (India) |
12/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
12/07/2024 |
|
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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The use of skull pin head holder to stabilise the head during craniotomy produces a strong noxious stimulus and sympathetic activation, resulting in abrupt increase in heart rate and arterial blood pressure and may increase the cerebral blood flow and intracranial pressure.Different anaesthetic and pharmacological techniques have been used to attenuate haemodynamic response to skull pin placement.Of the various methods mentioned, scalp block with local anaesthetic (LA) drug is commonly used. To prolong or for added effect, we add adjuvants to LAs. Alpha 2 agonists are one among the various adjuvants used along with  LAs in scalp block. The Mayfield skull-pin head holder is used to stabilize the head during neurosurgical procedures.They support the head without any direct pressure on the face, allow access to the airway and hold the head firmly in one position that can be finely adjusted for optimal neurosurgical exposure. |