CTRI Number |
CTRI/2019/06/019907 [Registered on: 27/06/2019] Trial Registered Prospectively |
Last Modified On: |
20/06/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of effect of Dexmedetomidine and Esmolol during Anaesthesia of Brain Tumour Surgery . |
Scientific Title of Study
|
Comparative Evaluation of Fixed dose Dexmedetomidine and Esmolol Infusion as an Anaesthetic Adjuvant during Intracranial Surgery for Supratentorial Tumor: a double blind randomized study. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Saikat Niyogi |
Designation |
Associate Professor |
Affiliation |
Bangur Institute of Neurology |
Address |
Anaesthesia Department,OT complex,8, Sambhunath Pandit St, Bhowanipore, Kolkata, West Bengal 700020
North Twentyfour Parganas WEST BENGAL 700020 India |
Phone |
9831732443 |
Fax |
|
Email |
saikatneuro1972@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Saikat Niyogi |
Designation |
Associate Professor |
Affiliation |
Bangur Institute of Neurology |
Address |
Anaesthesia department,OT Complex,8, Sambhunath Pandit St, Bhowanipore, Kolkata, West Bengal 700020
Medinipur WEST BENGAL 700020 India |
Phone |
9831732443 |
Fax |
|
Email |
saikatneuro1972@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Saikat Niyogi |
Designation |
Associate Professor |
Affiliation |
Bangur Institute of Neurology |
Address |
Anaesthesia Department,OT Complex8, Sambhunath Pandit St, Bhowanipore, Kolkata, West Bengal 700020
North Twentyfour Parganas WEST BENGAL 700020 India |
Phone |
9831732443 |
Fax |
|
Email |
saikatneuro1972@gmail.com |
|
Source of Monetary or Material Support
|
IPGMER SSKM Hospital,244A J C Bose Road, Kolkata(Calcutta) - 70002 |
|
Primary Sponsor
|
Name |
IPGMER SSKM HospitalKolkata |
Address |
244 A.J.C. Bose Road, Kolkata - 700 020. |
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 BISWADIP MONDAL |
OT COMPLEX, BANGUR INSTITUTE OF NEUROSCIENCES |
Anaesthesia Department,OT complex,8, Sambhunath Pandit St, Bhowanipore, Kolkata, West Bengal 700020 North Twentyfour Parganas WEST BENGAL |
917278857108
dr.biswadip1988@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IPGMER resarchOversight Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
intravenous dexmedetomidine infusion |
Dexmeditomidine infusion will be administered 1 mcg/kg in 20 min before induction[37]. . After 20 min study drug infusion, all the patients will shifted to operative room .Thereafter, dexmeditomidine infusion will be continued at the rate of 0.2 mcg/kg/hr throughout the operation. |
Comparator Agent |
intravenous esmolol infusion |
Esmolol infusion will be administered at the rate of 0.5 mg/kg within 20 min before induction.After 20 min study drug infusion, all the patients will shifted to operative room .Thereafter, esmolol infusion will be continued at 25 mcg /kg /min throughout the operation. |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Male |
Details |
1.AGE—20-55 YRS
2.SEX—either sex
3.GCS—14-15
4.SURGERY—elective intracranial surgery of a supratentorial tumour under general anaesthesia
5.ASA—1 to 2
6.BMI-- <30
7.HR-- >60/ min
8.BP—MAP> 80 mm hg
9. Patients or patient party willing to provide written informed consent
|
|
ExclusionCriteria |
Details |
1. Predicted difficult intubation
2. Preoperative beta blocker therapy, alpha-methyldopa,clonidine or other alpha2 agonist
3. Contraindication to beta blocker administration
4. Any history of drug abuse
5. Systemic illness such as considerable hepatic ,renal failure
6. Preoperative neurodeficit or aphasia
7. Known allergy to any of study drug
8. Uncontrolled htn, bronchial asthma, dysarrythmia including af, heart failure, cardiovascular complication, 2nd or 3rd degree heart block
9. Any pre operative haemodynamic instability
10. Pregnency
11. Any patient with difficult intubation requiring more than 20 seconds to intubate
12. Any prolonged operation ( duration > 3 hour )
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
changes in mean arterial pressure and heart rate
|
Basal,
20 min after study drug infusion,
After induction and intubation
at 30 min interval up to post operative 2 hrs. |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Compare the extubation time after withdrawing anesthetic and study drug
2. Pre and postoperative consciousness and sedation by HUDE Score.
3. Compare the total intraopertive propofol and fentanyl requirements
4. Any other side effects like postoperative nausea and vomiting, hypoxia and respiratory depression
|
before study drug
before induction
30 min after extubation |
|
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
|
Phase 1 |
Date of First Enrollment (India)
|
12/08/2019 |
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="6" 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)?
|
Brief Summary
|
After
approval of institutional ETHICS
committee, a through pre anaesthetic
assessment will be done for every patient. After obtaining written informed consent
from all the patients eligible for the study,
this randomized control trial will be conducted OT complex , department
of neurosurgery, Bangur institute of neurology, institute of post graduate
medical education & research ( IPGMER).
In this parallal group, randomized control
trial total 70 adults patients, aged between 20-55 years , ASA
physical status I or II of either sex,preoperative GCS 14-15 scheduled for
elective craniotomy for supratentorial tumour under general anaesthesia will be
taken as subjects for the study. We will compare perioperative haemodynamic
stability with dexmedetomidine and esmolol infusion in two selective groups. The study population
will be randomly allocated in two groups
with the help of computer
generated random number
( 1. D-GROUP –persons receiving Dexmedetomidine
infusion, 2.E-GROUP-persons receiving esmolol infusion).
Simple balanced randamization will be onduted.
All the drugs will be prepared in
identical syringes by an independent anaesthesiologist who not involved in this
study . Dexmedetomidine infusion will be prepared with 2 ml
dexmedetomidine ( 100µg/ml—total 200µg )
--mixed with 38 ml normal saline (total 40 ml-
concentration 5 mcg/ ml). Esmolol infusion will be prepared with 20 ml
undiluted Esmolol ( 10 mg/ml—total 200 mg) .
All the patients will be premedicated with
0.5 mg alprazolam at night day before surgery . Routine medications like
antiepileptic, will be continued as clinically indicated . All puncture sites will be treated with
topical local anaesthetic cream . preoperative GCS was assessed for all
patients.Upon arrival in the preoperating room, preoperative consciousness and
sedation were assessed by HUDES score .
Five lead surface electrocardiogram( ECG) ,pulse oximetry , NIBP were attached. A large bore i.v. canula was
inserted and intravenous(IV) normal saline(NS) was started at rate of 100ml /hr. Under local anaesthesia, A radial artery will be
cannulated for arterial pressure monitoring . Baseline HR, MAP, SPO2 all were measured before starting study drug
infusion as basal parameters. Both the study drug infusion
were started 20 mins[34] before induction .
Dexmeditomidine infusion was started
and continued at the rate of 1
mcg/kg/hour wand esmolol infusion was
continued at the rate of 0.5 mg/kg/hour for 20 min abefore induction[37]. . After 20 min study drug
infusion, all the patients were shifted to operative room .Thereafter,
dexmeditomidine infusion was continued
at the rate of 0.2 mcg/kg/hr and esmolol is continued at 25 mcg /kg /min.The
state of consciousness and haemodynamic parameters like MAP,HR,SPO2 all were recorded
again (1-7) [38] just before induction.
All the patients will be
pre-oxyginated with 100% O2 by a face mask for 3 min and IV fentanyl( 2mcg/kg )
was administered. The patient was induced with inj propofol infusion( 0.5 mg/kg
/min)[39] and infusion will be continued until BIS SCORE reach below
50.Time to reach BIS SCORE below 50 and total propofol requirement for
induction was noted. Neuromuscular block will be achieved by requirement administering atracurium ( 0.5 mg/
kg BW)and
manual ventilation will be
continued for at least 3 min
with 100% oxygen. Laryngoscopy and intubation
will be performed when TOF 0.
MAP,HR, SPO2 will be recorded just before and
after intubation and then at 1 min interval upto 5 min following intubation and
thereafter ,at every 15 min intervals till the end of operation.ETCO2 was maintained around 30-35 throughout the
operation.
Skin will be infiltrated
with 2% lignocaine+adrenaline before surgical incision. Anaesthesia was
maintained with low flow air in oxygen(
50:50—total 1 L/h). Propofol infusion was continued throughout the operation after at a
variable rate(25- 50 mcg/kg bw/ min) to
maintain BIS <50 [ 40 ]Neuromuscular block was maintained with IV atracurium 0.1mg/kg
as and when TOF >2 . [35]
. Hypertension (MAP>
100) and tachycardia ( HR> 100) will
be managed by injection fentanyl at 1 mcg/ kg bw for maximum consecutive two
times at 15 min intervals, followed by
IV 10 mg propofol bolus, if not responded.Total intraoperative propofol and fentanyl requirement were also
noted.
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