| CTRI Number |
CTRI/2024/01/061259 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
31/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effectiveness of Dexmedetomidine vs Ketamine along with local anaesthetic Ropivacaine in blocking scalp nerves for awake brain surgeries |
|
Scientific Title of Study
|
Comparison of the efficacy of Dexmedetomidine versus Ketamine as an adjunct to Ropivacaine for Scalp Block during Awake Craniotomy Surgery- A Clinical Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC-INT/2023/MD-1323 version 1 dated 20/11/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankur Luthra |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia, 4th Floor, Block - A, Nehru Hospital, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9868057732 |
| Fax |
|
| Email |
zazzydude979@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankur Luthra |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia, 4th Floor, Block - A, Nehru Hospital, PGIMER, Sector 12, Chandigarh
CHANDIGARH
160012
India |
| Phone |
9868057732 |
| Fax |
|
| Email |
zazzydude979@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Muhammed Faiz |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia, 4th Floor, Block - A, Nehru Hospital, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8825585208 |
| Fax |
|
| Email |
aws8041@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Ankur Luthra |
| Address |
Department of Anaesthesia, 4th floor, A-Block, Nehru Hospital, PGIMER, Chandigarh |
| 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 |
| Muhammed Faiz M |
Main OT Complex, Department of Anaesthesia, PGIMER |
Division of Neuroanaesthesia, Department of Anaesthesia and Intensive Care
Chandigarh
CHANDIGARH |
8825585208
aws8041@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C713||Malignant neoplasm of parietal lobe, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Patients receiving 20ml 0.5% Ropivacaine + Dexmedetomidine 1 mics/kg once 15 min before the surgery onset |
| Comparator Agent |
Ketamine |
Patients receiving 20ml 0.5% Ropivacaine + Ketamine 0.5 mg/kg once 15 min before the surgery onset |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
46 ASA I and II patients aged between 18-65 years scheduled for Elective Awake Craniotomy surgery for brain tumors will be enrolled in this study |
|
| ExclusionCriteria |
| Details |
i. Refusal of consent
ii. Known allergy to Dexmedetomidine or Ketamine
iii. Prior Craniotomy / Chronic analgesic use
iv. Coagulopathy
v. Schizophrenia or bipolar disorders
vi. Uncontrolled anxiety or depression
vii. Hepatic or Renal impairment (Stage III or IV)
viii. BMI >35 kg/m2
ix. Significant Respiratory disease (COPD or Asthma requiring daily therapy)
x. Significant Cardiovascular disease (2nd/3rd degree heart block, Congestive heart failure, symptomatic coronary artery disease)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first request of rescue analgesic drug by the patient in the postoperative period which is defined as the time interval between onset of sensory blockade to the first use of rescue analgesic drug as demanded by the patient (NRS more than 4) |
Within 24 hours whenever NRS more than 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time needed for onset of sensory block assessed by loss of pin prick sensation every 1 minute.
|
Every 1 minute |
To assess the intraoperative hemodynamics (HR, NIBP, MAP, RR, SpO2) at 10 min interval and postoperatively at 2 hours interval till 24 hours.
|
at 10 min interval and postoperatively at 2 hours interval till 24 hours. |
| 3. To assess the sedation score intraoperatively by Richmond Agitation And Sedation Scale39 (RASS) at 10 min interval after opening of dura for allowing neurological testing (power, speech, calculation, language etc. |
10 min and after opening of dura |
| 4. To assess the Pain scores by Numerical Rating Scale (NRS) postoperatively at 2 hourly intervals till 24 hours. |
2 hourly till 24 hours |
| To assess the number of episodes of of adverse events like bradycardia, hypotension, respiratory depression, psychosis by SOMC scale and PONV by 4-Point PONV scale |
Till 24 hours |
| Total rescue analgesic drug requirement in 24 hours. |
24 hours |
| Time to discharge from PACU using Modified Aldrete Scoring |
Time to discharge |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "63"
Final Enrollment numbers achieved (India)="63" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2024 |
| Date of Study Completion (India) |
15/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/11/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [zazzydude979@gmail.com].
- For how long will this data be available start date provided 01-03-2024 and end date provided 01-03-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In summary, Dexmedetomidine and Ketamine can be effective adjuvants for Scalp Block Anaesthesia, with different profiles of efficacy and side effects. The choice of adjuvant should be based on the specific needs of the patient and the procedure, as well as the cliniciann’’s experience and comfort with each drug.Since there is no study comparing the effectiveness of Dexmedetomidine versus Ketamine as an adjuvant for Scalp Block in adults, we would like to compare the effectiveness of Dexmedetomidine (1 μg/kg) with Ketamine (0.5 mg/kg) as an adjuvant to 20 ml 0.5% Ropivacaine for Scalp Block infiltration in adult population aged 18-65 years undergoing Awake Craniotomy surgery. We hypothesize that addition of Ketamine 0.5 mg/kg is comparable to Dexmedetomidine 1 μg/kg as adjuncts to Ropivacaine 0.5% for prolonging the duration of analgesia post-Scalp Block in patients undergoing Awake Craniotomy surgery. |