| CTRI Number |
CTRI/2026/01/102470 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of intravenous lignocaine (local anaesthetic) + sub anaesthetic (low dose) ketamine (intravenous induction agent) versus scalp block (regional anesthesia) in blunting the fight or flight response to skull pin head holder application in elective craniotomy. |
|
Scientific Title of Study
|
Comparision of sub-anaesthetic dose of intravenous ketamine plus lignocaine versus lignocaine scalp block in blunting the sympathetic response to skull pin head holder application for elective.craniotomy- a non inferiority trial |
| 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 Kruti Jain |
| Designation |
Postgraduate junior resident |
| Affiliation |
All India Institue of Medical Sciences, Raipur |
| Address |
B block major Operation theatre complex, 4th floor,Department of Anaesthesiology, AIIMS Raipur, Tatibandh, Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
7680915957 |
| Fax |
|
| Email |
krutibhuta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Subrata Kumar Singha |
| Designation |
Professor and head of the department of Anaesthesiology and critical care |
| Affiliation |
All India Institue of Medical Sciences, Raipur |
| Address |
B block major Operation theatre complex, 4th floor,Department of Anaesthesiology,AIIMS Raipur, Tatibandh, Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881767 |
| Fax |
|
| Email |
subrat@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kruti Jain |
| Designation |
Postgraduate junior resident |
| Affiliation |
All India Institue of Medical Sciences, Raipur |
| Address |
B block major Operation theatre complex, 4th floor, Department of Anaesthesiology, AIIMS Raipur, Tatibandh, Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
7680915957 |
| Fax |
|
| Email |
krutibhuta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Kruti Jain postgraduate resident in Department of Anaesthesiology AIIMS Raipur Tatibandh Raipur Chhattisgarh India 492099 |
|
|
Primary Sponsor
|
| Name |
DrKruti Jain |
| Address |
B block 4th floor major Operation theatre Department of Anaesthesiology AIIMS Raipur Tatibandh Raipur Chhattisgarh India 492099 |
| 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 Kruti Jain |
All India Institue Of Medical Sciences |
Department of Anaesthesiology fourth floor B block major Operation theatre AIIMS Raipur Tatibandh Raipur Chhattisgarh 492099
Raipur
CHHATTISGARH |
7680915957
krutibhuta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECAIIMSRAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous lignocaine plus ketamine |
Intravenous lignocaine will be given as a bolus dose of 1.5 mg/kg followed by an intravenous infusion of lignocaine at 1.5 mg/kg/hr for 10 minutes and intravenous ketamine in the dose of 0.3 mg/kg followed by an intravenous infusion
Of ketamine at the rate of 0.3mg/kg/hr for 10 minutes prior to application of the skull pin head holder after the patient has been induced with standard general anesthesia protocol
This will be a one time intervention |
| Comparator Agent |
Scalp block |
Lignocaine 1% 20 ml will be infiltrated in the scalp using landmark guided technique after the induction of general anaesthesia using standard protocol and the skull pin head holder will be applied after 5 minutes of administering the scalp block the sympathetic response to skull pin head holder application will be seen
This will be a one time intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a.Patients in age group 18-60 years, both males and females.
b.Patients posted for elective craniotomy.
Patients with ASA PS 1-3. |
|
| ExclusionCriteria |
| Details |
a.Patients with pre-operative GCS less than 8/15.
b.Patients allergic to drugs used in the study.
c.Patients with co-morbidities like uncontrolled hypertension, coronary artery disease, heart failure,chronic liver disease, BMI greater than 30kg/m2, seizure disorders.
d.Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Subanesthetic dose of intravenous ketamine with lignocaine is non-inferior to scalp block in blunting the hemodynamic responses to skull pin application for craniotomy. |
The heart rate and blood pressure will be measured in both the groups of patient immediately after application of skull pin head holder and there after at 1 minute 2 minutes 5 minutes 10 minutes and 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quantifying the requirement of rescue intravenous fentanyl boluses in both the groups |
At the end of 15 minutes after the application of skull pin head holder |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 2 |
|
Date of First Enrollment (India)
|
16/02/2026 |
| 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 Yet Recruiting |
| 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
|
Application of skull pin head holder in craniotomies is routinely used which elicits a roboust sympathetic response which has the potential to affect the homeostasis negatively one of the principles of anaesthesia is to ensure adequate analgesia and patients undergoing surgeries will be voluntarily enrollled after they meet the inclusion criteria and will be randomised into two groups one with intravenous lignocaine and ketamine whilst the other into scalp block group hemodynamic changes will be noted when the skull pin head holder is applied and intermittently until the next fifteen minutes. |