| CTRI Number |
CTRI/2015/06/005875 [Registered on: 04/06/2015] Trial Registered Retrospectively |
| Last Modified On: |
05/01/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Screening |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of dexmedetomidine on cerebral autoregulation during general anaesthesia |
|
Scientific Title of Study
|
Effect of dexmedetomidine on cerebral autoregulation and CO2 reactivity during sevoflurane anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUJOY BANIK |
| Designation |
SENIOR RESIDENT(DM) NEUROANAESTHESIOLOGY |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES(AIIMS), NEW DELHI, INDIA |
| Address |
ROOM NO 709A 7TH FLOOR CARDIO NEURO CENTER
AIIMS ANSARI NAGAR
South
DELHI
110087
India |
| Phone |
9990013004 |
| Fax |
|
| Email |
drsujoyb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
GIRIJA PRASAD RATH guide |
| Designation |
ADDITIONAL PROFESSOR NEUROANAESTHESIOLOGY |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES(AIIMS), NEW DELHI, INDIA |
| Address |
ROOM NO 704 7TH FLOOR CARDIO NEURO CENTER
AIIMS ANSARI NAGAR
South
DELHI
110029
India |
| Phone |
9868398204 |
| Fax |
|
| Email |
girijarath.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sujoy banik |
| Designation |
senior resident(DM) neuroanaesthesiology |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES(AIIMS), NEW DELHI, INDIA |
| Address |
ROOM NO 709A 7TH FLOOR CARDIO NEURO CENTER
AIIMS ANSARI NAGAR
South
DELHI
110029
India |
| Phone |
9990013004 |
| Fax |
|
| Email |
drsujoyb@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
ANSARI NAGAR NEW DELHI 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SUJOY BANIK |
NEURO OT, CARDIO NEURO CENTER, AIIMS NEW DELHI |
CARDIO NEURO CENTER AIIMS NEW DELHI
South
DELHI |
9990013004
drsujoyb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE/ETHICS SUB-COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA I, UNDERGOING LUMBAR LAMINECTOMY WITH NO INTRACRANIAL PATHOLOGY, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine/placebo |
dexmedetomidine 1mcg/kg iv loading dose over 10 minutes followed by 0.5mcg/kg/hr iv infusion as maintenance dose(Group D) for rest of the surgery till 10 minutes before skin closure. placebo infusion of normal saline(Group C) at similar dose rates assuming the above dose as if for dexmedetomidine,for similar duration. |
| Comparator Agent |
placebo |
effect on cerebral autoregulation by transient hyperemic response test/CO2 reactivity under sevoflurane anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
adults aged 18-60 years who present for lumbosacral spine surgery. |
|
| ExclusionCriteria |
| Details |
1. Refusal of consent
2. Pregnancy
3. Morbid obesity
4. Patients with comorbidities, ASA II and above , including cardiac rhythm abnormalities
5. Addictions(smoking/regular alcohol intake/IV drug abuse)
6. Drug intake(OCPs/SSRIs/TCAs/anticonvulsants/statins etc.)
7. Carotid disease/history of syncope/dizziness
8. Hyperlipidemia |
|
|
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 |
| 1. to study the effect of dexmedetomidine as an anaesthetic adjuvant on cerebral autoregulation and CO2 reactivity using transcranial doppler |
5 mins after induction of anesthesia when BIS stable between 40-50. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. effect of dexmedetomidine on intraoperative haemodynamic parameters during various stages of anaesthesia
2. anaesthetic agent consumption
3. time to recovery, extubation and quality of emergence
4. side effects and complications noted with the technique
|
intraoperative
postoperative |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/12/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dexmedetomidine
(DEX) has been shown to provide good perioperative haemodynamic stability with
decreased intraoperative opioid requirements. It may have neural protective
effects, and thus may be a suitable anaesthetic adjuvant to neurosurgical
anaesthesia.Dexmedetomidine caused a dose-related reduction in both CBF and
CMR in healthy subjects. anticipated adverse effects of dexmedetomidine on the
cerebral oxygen supply– demand relation, i.e., the CBF/CMR ratio, were
not apparent during either normocapnia or hypocapnia. The data contradict those
of previous investigations in dogs that indicated that dexmedetomidine does not
cause a reduction in CMR.The effect of dexmedetomidine on autoregulation has not been
well studied,especially in the context of its use as an anaesthetic adjuvant
and its documented effect of reduction of the cerebral blood flow, which may be
of clinical relevance in the intraoperative context. Therefore this study was
designed to study the effect of dexmedetomidine on cerebral autoregulation
during its use as an anaesthetic adjuvant. Primary outcome:
1.
to study the effect of
dexmedetomidine as an anaesthetic adjuvant on cerebral autoregulation
and CO2 reactivity using transcranial
doppler
Secondary outcomes:
1.
effect of dexmedetomidine on
intraoperative haemodynamic parameters during various stages of anaesthesia
2.
anaesthetic agent consumption
3.
time to recovery, extubation
and quality of emergence
4.
side effects and
complications noted with the technique |