FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close