CTRI Number |
CTRI/2021/11/037735 [Registered on: 01/11/2021] Trial Registered Prospectively |
Last Modified On: |
01/11/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
study the effect of dexmedetomidine drug in preventing confusional state and agitation that occurs in patients undergoing brain surgery under general anaesthesia. |
Scientific Title of Study
|
Comparison of the effect of intraoperative infusion of dexmedetomidine on emergence agitation and delirium in children undergoing craniotomy with total intravenous anaesthesia (TIVA) with propofol – A randomized controlled clinical 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 Ajisheen BorgeoS S |
Designation |
Post graduate Registrar in Anaesthesiology |
Affiliation |
Christian Medical College,Vellore |
Address |
Department of Anesthesiology,
Christian Medical College, Vellore,
Department of Anesthesiology,
Christian Medical College, Vellore,
Vellore TAMIL NADU 632004 India |
Phone |
9995927960 |
Fax |
|
Email |
sheenborgeo@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Georgene singh |
Designation |
Professor |
Affiliation |
Christian Medical College |
Address |
Department of Anesthesiology,
Christian Medical College, Vellore,
Department of Anesthesiology,
Christian Medical College, Vellore,
Vellore TAMIL NADU 632004 India |
Phone |
9443292504 |
Fax |
|
Email |
georgene@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
Name |
Dr Georgene singh |
Designation |
Professor |
Affiliation |
Christian Medical College |
Address |
Department of Anesthesiology,
Christian Medical College, Vellore,
Department of Anesthesiology,
Christian Medical College, Vellore,
Vellore TAMIL NADU 632004 India |
Phone |
9443292504 |
Fax |
|
Email |
georgene@cmcvellore.ac.in |
|
Source of Monetary or Material Support
|
Institutional Review Board,
Christian Medical College
Vellore |
|
Primary Sponsor
|
Name |
Institutional Review BoardChristian Medical CollegeVellore |
Address |
Christian Medical College, Vellore,Bagayam Campus,
632002 |
Type of Sponsor |
Private 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 |
DrAjisheen Borgeo |
Christian Medical College |
Neurosurgery theatre, Neurosurgery wards, and Neurosurgical ICU Vellore TAMIL NADU |
9995927960
sheenborgeo@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics Commitee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: G978||Other intraoperative and postprocedural complications and disorders of nervous system, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
dexmedetomidine infusion |
Intervention arm will receive an infusion of Propofol 150-250 mcg/kg/hr, Fentanyl 1-2 mcg/kg/hr titrated to a BIS of 40-60 without volatile anaesthetic. It will also receive dexmedetomidine infusion at a rate of 0.5mcg/kg/hr as an adjunct to TIVA
|
Comparator Agent |
Normal Saline as Placebo |
Comparator Arm will receive an infusion of Propofol 150-250 mcg/kg/hr, fentanyl 1-2 mcg/kg/hr, titrated to a BIS of 40-60 without volatile anaesthetic It will get 0.5mg/kg/hr infusion of saline as placebo.
|
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
18.00 Year(s) |
Gender |
Both |
Details |
ASA 1 and 2 Paediatric age group patients planned for craniotomy under general anaesthesia will be recruited for the study. |
|
ExclusionCriteria |
Details |
1)ASA 3 and above.
2)Known allergy to study drugs.
3)History of renal disease-age appropriate e-GFR criteria
4)History of liver disease.
5)Psychiatric illness
6)Heart block, known case of seizure disorder coming for seizure surgery
7)Patient refusal
8)GCS <15
|
|
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 |
Emergence Delirium as assessed by the PAED scale |
7 time points,T1-at recovery,T2 after 2 hours of recovery,T3-6 hours,T4-12 hours,T5-24 hours,T6- 36 hours,T7-48 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
1)Emergence Agitation as assessed by Watcha, Richmond’s agitation sedation scale
2.Intraoperative and Postoperative haemodynamics
3.Recovery characteristics
4.Postoperative Analgesia
|
7 time points,T1-at recovery,T2 after 2 hours of recovery,T3-6 hours,T4-12 hours,T5-24 hours,T6- 36 hours,T7-48 hours |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
01/11/2021 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
planned to publish after completion. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Emergence
agitation
and delirium are well-described phenomena during emergence from general
anaesthesia, especially in the paediatric population.
Emergence
Agitation (EA) is an “unpleasant state of extreme arousal†characterized by
non-purposeful movement, restlessness, thrashing, incoherence, inconsolability,
and unresponsiveness usually following emergence from General Anaesthesia. The
true incidence of EA in children is unclear but has been estimated to be
between 10 - 80 %.
Emergence
Delirium (ED) is an altered state of
consciousness, which begins with emergence from anesthesia and continues
throughout the early recovery period. ED is a disturbance of awareness of, or
attention to, the child’s environment, and manifests as disorientation,
hyperactive/hypoactive behavior, and hypersensitivity in the immediate period
after anesthesia.
Although
there is significant ongoing research on the incidence, risk factors, and the
probable consequences of EA/ED, neurosurgical procedures have generally been
exempt owing to the complexity in differentiation between the neurological
conditions and the effect of recovery from anaesthetics. A study done in the adult neurosurgical population
has shown a higher incidence of EA in neurosurgical patients (29%).
Children
undergoing craniotomy are more vulnerable to the stress that follows EA/ED. In
a recent observational study done in our institution, the incidence of emergence
agitation was 28% in the paediatric population undergoing craniotomy.
Total intravenous
anaesthetic (TIVA) techniques with propofol, which has been the mainstay of neurosurgical
practice have been associated with a reduced incidence of EA/ED in other
surgical procedures. However, in children, it is often necessary to use high
concentration volatile anaesthetics to induce general anaesthesia before
initiation of TIVA as they may not cooperate for intravenous access which
predisposes them to develop EA/ED.
Dexmedetomidine
is a selective alpha-2 receptor agonist acting on alpha-2
receptors in the locus ceruleous of the pons. Recently, Dexmedetomidine is
beneficial in reducing the incidence of EA/ED in children undergoing general
anaesthesia. However, there is no literature regarding its use in the
paediatric neurosurgical population.
We hypothesize
that the use of intravenous dexmedetomidine as an infusion at a dose of
0.5mcg/kg/hr could reduce the incidence of EA/ED in paediatric patients
undergoing craniotomy. |