| CTRI Number |
CTRI/2025/07/091948 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of ketamine as an adjuvant to scalp anesthesia for patients undergoing head surgery |
|
Scientific Title of Study
|
Evaluation of ketamine as an adjuvant to scalp block for patients undergoing craniotomy |
| 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 Amrita Roy |
| Designation |
DrNB Neuroanesthesia resident |
| Affiliation |
Institute of Neurosciences |
| Address |
Institute of Neurosciences
6B A.J.C Bose Road, Kolkata
6B A.J.C Bose Road, Kolkata
Kolkata
WEST BENGAL
700017
India |
| Phone |
8348641137 |
| Fax |
- |
| Email |
royamrta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Roy |
| Designation |
DrNB Neuroanesthesia resident |
| Affiliation |
Institute of Neurosciences |
| Address |
Institute of Neurosciences
6B A.J.C Bose Road, Kolkata
6B A.J.C Bose Road, Kolkata
Kolkata
WEST BENGAL
700017
India |
| Phone |
8348641137 |
| Fax |
- |
| Email |
royamrta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Roy |
| Designation |
DrNB Neuroanesthesia resident |
| Affiliation |
Institute of Neurosciences |
| Address |
INSTITUTE OF NEUROSCIENCES
6B A.J.C Bose Road, Kolkata
6B A.J.C Bose Road, Kolkata
Kolkata
WEST BENGAL
700017
India |
| Phone |
8348641137 |
| Fax |
- |
| Email |
royamrta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Neurosciences
6B A.J.C Bose Road, Kolkata - 700017, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Institute of Neurosciences Kolkata |
| Address |
Institute of Neurosciences
6B A.J.C Bose Road, Kolkata - 700017, West Bengal, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Amrita Roy |
INSTITUTE OF NEUROSCIENCES |
6B A.J.C Bose Road, Kolkata
Department of Neuroanesthesia
Operation Theater 1 and 2
Kolkata
WEST BENGAL |
8348641137
royamrta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of the Institute of Neurosciences Kolkata (IEC-I-NK) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G893||Neoplasm related pain (acute) (chronic), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine 0.25% and lignocaine adrenaline (1:1) |
Solution prepared by mixing bupivacaine 0.25% and lignocaine adrenaline (1:1) is given in scalp block in patients undergoing craniotomy |
| Intervention |
Ketamine |
Ketamine as an adjuvant to the solution prepared by mixing bupivacaine 0.25% and lignocaine adrenaline (1:1) at a maximum dose of 1mg/kg, in scalp block for patients posted for craniotomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective craniotomoy for supratentorial space occupying lesion, duration of surgery less than 4 hours, body mass index less than 24, ASA grade 1 or 2 |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. ASA grade 3 or 4
3. Surgery for cerebral aneurysm or av malformation
4. Emergency surgery
5. Morbid obesity |
|
|
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 |
| Reduction in pain assessed by visual analog scale |
Baseline, 2 hours,4 hours,8 hours,12 hours,24 hours (post operative) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total intraoperative opioid consumption, intraoperative mean arterial pressure & heart rate |
Every 30 minutes till closure & at extubation |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 4 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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="0"
Months="11"
Days="30" |
|
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
|
there
are limited studies that have attempted to investigate the effect of ketamine
in scalp nerve block with local anaesthetic on attenuation of haemodynamic
response and postoperative analgesia in patients undergoing craniotomy. Therefore,
the present double-blinded randomized clinical trial will be conducted to evaluate
the efficacy of ketamine as an adjuvant to scalp nerve block for postoperative analgesia
in patients undergoing elective craniotomy for supratentorial space occupying
lesion, in a tertiary care hospital of Eastern India. |