| CTRI Number |
CTRI/2022/10/046643 [Registered on: 19/10/2022] Trial Registered Prospectively |
| Last Modified On: |
18/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs named dexmedetomidine and ketamine during general anesthesia (state of unconsciousnessor asleep) in brain surgeries for maintenance of blood pressure, heart rate, depth of sleep and pain control during surgery and post surgery pain management intervention. |
|
Scientific Title of Study
|
Comparison between Intraoperative DEXMEDETOMIDINE and LOW-DOSE KETAMINE as Anesthetic Adjuvant for maintenance of Intraoperative Hemodynamic Stability in patients undergoing Elective Supratentorial Craniotomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Jaiswal |
| Designation |
Senior Resident - DrNB Trainee Neuroananesthesia |
| Affiliation |
Paras Hospital |
| Address |
Paras Hospital,
Block C, Phase 1
Sector 43
Sushant lok Rd
Gurgaon
HARYANA
122002
India |
| Phone |
8527500275 |
| Fax |
|
| Email |
ankita772@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Mohan Gupta |
| Designation |
HOD & Senior Consultant Neuroananesthesia |
| Affiliation |
Paras Hospital |
| Address |
Paras Hospital
Block C
Phase 1
Sector 43
Sushant lok Rd
Gurgaon
HARYANA
122002
India |
| Phone |
9871174766 |
| Fax |
|
| Email |
docmmg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Jaiswal |
| Designation |
Senior Resident - DrNB Trainee Neuroananesthesia |
| Affiliation |
Paras Hospital |
| Address |
Paras Hospital,
Block C, Phase 1
Sector 43
Sushant lok Rd
Gurgaon
HARYANA
122002
India |
| Phone |
8527500275 |
| Fax |
|
| Email |
ankita772@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Paras Hospital |
| Address |
Department of Neuroanaesthesia
Block C, Phase 1
Sector 43
Sushant lok Rd |
| 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 Ankita Jaiswal |
Paras Hospital |
Department of Neuroanaesthesia and Neurocritical Care/ Neuroanaesthesia division/ ward No 4, 4th floor, Block C, Sushant Lok Phase 1, Sector 43
Gurgaon
HARYANA |
8527500275
ankita772@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Paras Hospital, Gurugaon |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Using Graseby 2000 (smiths medical) infusion pump Group Dexmedetomidine received 1 mcg/kg bolus for 10 mins prior to induction and infusion rate as 0.5 mcg/kg/hr till start of dura closure.(intravenous route) |
| Comparator Agent |
Ketamine |
Using Graseby 2000 (smiths medical) infusion pump Group Ketamine 0.5 mg/kg bolus for 10 mins prior to induction and infusion rate as 250 mcg/kg/hr till start of dura closure.(intravenous route) for hemodynamic stability assessment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients aged 18 - 65 years. 2 American Society of Anesthesiologists I/II. 3 Elective supratentorial craniotomy |
|
| ExclusionCriteria |
| Details |
1 Known allergy to drugs.
2 History of renal,liver, cerebrovascular and cardiovascular (mod/severe) disease.
3 Chronic beta blocker treatment with heart rate or preoperative HR< 50/min.
4 Isolated frontal lobe surgery. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters - Mean arterial pressure( MAP) |
Baseline values will be recorded (average of 3) prior to start of study drug. At 0,5 and 10 mins hemodynamic parameters and BIS are recorded. Then at induction , intubation and incision. In between recordings at 15 min interval. At stopping study drug and starting atracurium. Followed by stopping atracurium and tapering propofol. Again recordings will be taken at emergence and extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic parameter SBP and DBP, HR, BIS
Requirement of other annaetshetic drugs propofol, atracurium.
Vas score post extubation
Analgesic requirement.
|
Baseline values will be recorded (average of 3) prior to start of study drug. At 0,5 and 10 mins hemodynamic parameters and BIS are recorded. Then at induction , intubation and incision. In between recordings at 15 min interval. At stopping study drug and starting atracurium. Followed by stopping atracurium and tapering propofol. Again recordings will be taken at emergence and extubation
Visual analogue scale till 24 hours post surgery. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/10/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The goals of Neuroanaesthesia are to ensure stable perioperative stable hemodynamics and avoid sudden rise in intracranial pressure (ICP) to prevent acute brain swelling. Craniotomy is associated with intense surgical stimuli causing sympathetic activation which results in marked changes in systemic arterial pressure and cerebral blood flow and hence raised ICP and reduction in cerebral perfusion leading to cerebral ischemia especially in patients with impaired cereberal autoregulation. Hence prevention and control of nociceptive stimulus are of utmost importance. Dexmedetomidine is alpha 2 agonist having sedative, anxiolytic, analgesic and sympatholytic properties. Ketamine is N - methyl D- Aspartate antagonist producing sedation, catalepsy, somatic analgesia and snympathetic nerve stimulation. This comparison studies aim to assess efficacy of these drugs on intraoperative hemodynamic stability, requirements of other anaesthetic agents, emergence, assessment of postoperative pain and side effects. |