| CTRI Number |
CTRI/2024/11/076623 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of dexmeditomidine on hemodynamic stability and requirements for anaesthetic agents on patients who are electively undergoing infratentorial tumour surgery |
|
Scientific Title of Study
|
Role of Dexmedetomidine on Haemodynamics and Anaesthetic Requirement In Patients Undergoing Elective
Infratentorial Tumour Surgery: A Prospective Randomized Double Blind Placebo Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Twinkle |
| Designation |
Junior resident |
| Affiliation |
Rajendra Institute of Medical Science |
| Address |
Department of anaesthesia,Room no.-108, pg girls hostel no.-7, Rajendra institute of medical science, ranchi, jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
9304920327 |
| Fax |
|
| Email |
twinklesagar2209@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Azizul Haque |
| Designation |
Associate Professor |
| Affiliation |
Rajendra Institute Of Medical Science |
| Address |
Department Of Anaesthesiology RIMS, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9771185861 |
| Fax |
|
| Email |
drazizulhaque61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Shrivastava |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra Institute Of Medical Science |
| Address |
Department Of Anaesthesiology, RIMS, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9958912712 |
| Fax |
|
| Email |
shrivastava2911@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of medical sciences, Ranchi, Jharkhand,India, 834009 |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute Of Medical Science |
| Address |
Bariatu, Ranchi, jharkhand ,India,834009 |
| Type of Sponsor |
Government medical college |
|
|
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 Twinkle |
Rajendra Institute of Medical Sciences |
Department of Anesthesiology,Rajendra Institute Of Medical Science, Bariatu, Ranchi,Jharkhand,India, 834009
Ranchi
JHARKHAND |
9304920327
twinklesagar2209@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D331||Benign neoplasm of brain, infratentorial, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% normal saline |
0.9% normal saline infusion is started in control group 30min before induction at the rate of 1mcg/kg/hr for 10min and then 0.4mcg/kg/hr till skin closure |
| Intervention |
Dexmeditomidine |
Dexmeditomidine infusion started in test group 30 min before induction at the rate of 1mcg/kg/hr for 10min and then 0.4mcg/kg/hr till skin closure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade- 1&2
surgery duration 4-5 hr
elective surgeries
infratentorial tumor surgery
GCS not less than 14-15
|
|
| ExclusionCriteria |
| Details |
hypertensive on other alpha 2 agonist
severe intracranial hypertension
preoperative heart rate less than 45
2&3 degree AV block
patient on anti arryhthmic drug and beta blocker
anticipated difficult intubation
hypersenstivity to test drug
pregnancy
morbid obesity
patient with chronic lung, renal and hepatic disease
post head injury |
|
|
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 |
| To observe the effect of dexmedetomidine on Heart rate, Systolic blood pressure, Diastolic blood pressure, Mean arterial pressure during intraoperative period. |
baseline before induction
every 5 min after induction
end of surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| intraoperative fentanyl requirement |
Intraoperative period from induction of anesthesia till end of surgery |
| Minimum alveolar concentration [MAC] of isoflurane to maintain optimum hemodynamics required for the surgery |
intraoperative period from induction of anesthesia till end of surgery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
21/11/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Patients with intracranial pathology are in
compromised state of cerebral dynamics, intracranial pressure and cerebral
perfusion. Cerebral autoregulation keeps cerebral blood flow constant in face
of changing perfusion pressure or Mean arterial pressure (MAP) by altering
cerebrovascular resistance. Sharp fluctuation in cerebral blood flow, cerebral
blood volume and intracranial pressure is a risk factor for neurological deterioration.
Dexmedetomidine is highly selective alpha 2 agonist with hypnotic, sedative,
anxiolytic, sympatholytic and analgesic properties which help in maintaining
hemodynamic stability throughout intraoperative period. In addition to this it
also reduces the requirement of volatile anaesthetic agent like isoflurane and
opioid like fentanyl during intraoperative period. The purpose of this study is
to investigate whether dexmedetomidine administered during surgery can maintain
hemodynamic stability in patient those who are undergoing elective
infratentorial tumour surgery
|