FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/02/011945 [Registered on: 19/02/2018] Trial Registered Retrospectively
Last Modified On: 28/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A comparison of two methods of hypotensive anaestesia during mastoid surgery 
Scientific Title of Study   Efficacy of Dexmedetomidine and Propofol in maintaining hypotension during mastoid surgery – a comparative study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anuradha T 
Designation  Junior resident 
Affiliation  Jubilee Mission Medical College & Research Institute 
Address  Department of Anaesthesiology Jubilee Mission Medical College East Fort Thrissur
Department of Anaesthesiology Jubilee Mission Medical College East Fort Thrissur
Thrissur
KERALA
680005
India 
Phone  04872462000  
Fax    
Email  anuradha_t2000@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Usha Shenoy 
Designation  Professor 
Affiliation  Jubilee Mission Medical College & Research Institute 
Address  Department of Anaesthesiology Jubilee Mission Medical College East Fort Thrissur

Thrissur
KERALA
680005
India 
Phone  04872462000  
Fax    
Email  rss.uss@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR ANURADHA T 
Designation  JUNIOR RESIDENT 
Affiliation  Jubilee Mission Medical College & Research Institute 
Address  Department of Anaesthesiology Jubilee Mission Medical College East Fort Thrissur

Thrissur
KERALA
680005
India 
Phone  04872462000  
Fax    
Email  anuradha_t2000@yahoo.com  
 
Source of Monetary or Material Support  
JUBILEE MISSION MEDICAL COLLEGE THRISSUR 
 
Primary Sponsor  
Name  Jubilee Mission Medical College and Research Institute 
Address  Department of Anaesthesiology, Jubilee Mission Medical College & Research Institute East Fort Thrissur 
Type of Sponsor  Private 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 Anuradha T  Jubilee Mission Medical College & Research Institute  Department of Anaesthesiology, Jubilee Mission Medical College East Fort Thrissur
Thrissur
KERALA 
9847120761

anuradha_t2000@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, JUBILEE MISSION MEDICAL COLLEGE, THRISSUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Coming for mastoid surgery, (1) ICD-10 Condition: H65-H75||Diseases of middle ear and mastoid,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine   Dexmedetoidine bolus and infusion is compared with propofol boluses, to know which group has better hypotension,slower heart rate, quality of surgical field and postoperative pain, nausea, vomiting 
Comparator Agent  Propofol  After induction of anaesthesia by a common protocol in mastoid surgery, Propofol boluses are used to maintain hypotension in group P 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1) American Society of Anaesthesiologists ( ASA) Category I – II patients
2)aged 18 – 55 years
3)undergoing middle ear surgery 
 
ExclusionCriteria 
Details  1) Coexisting hepatic, renal, cardiovascular,
neuromuscular or hematological diseases
2) Patients on antipsychotics, adrenergic blockers, Monoamine oxidase (MAO) inhibitors
3)History of drug allergy to alpha-2 agonists  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The main aim of study is to know the drug’s efficacy in maintaining hypotension and
lowering heart rate which affects the quality of the surgical field. 
October 2016 TO September 2017
 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of surgical field, incidence of bradycardia and postoperative pain, nausea and vomiting,sedation and shivering  October 2016 TO September 2017
 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/10/2016 
Date of Study Completion (India) 14/07/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

 Controlled hypotensive anaesthesia is very useful in mastoid surgery using operating microscope to obtain a good surgical field. This study compares two methods of maintaining controlled heart rate and blood pressure.

Methods: There were 2 groups, D and P of 35 patients each. General anaesthesia was induced by a common protocol. In group D, dexmedetomidine bolus (0.2 mcg/kg) at induction and infusion (0.2 mcg/kg/h) were given. In group P, propofol boluses (1 mg/kg) were used to maintain hypotension. Target mean arterial pressure (MAP) was 55- 65 mm Hg and target heart rate 60 -75 beats per minute. Parameters noted were heart rate and blood pressure (systolic, diastolic, mean), need of other interventions to maintain heart rate ( beta blocker or atropine) and blood pressure (vasopressor, increasing concentration of inhalational agent), intraoperative bleeding score and recovery room parameters (pain, shivering, nausea and vomiting)

Results & Discussion : Both arms maintained MAP within the target range. Dexmedetomidine at dose of 0.2 mcg/kg bolus and infusion, is equally efficacious as Propofol boluses in maintaining mean arterial pressure within a range of 55 – 65 mm Hg. Heart rate control (60-75 per minute) was better in dexmedetomidine group, requiring significantly lesser amount of beta blocker than propofol. Use of  Dexmedetomidine, even in such a lower dose, significantly reduced the requirement of inhalational agent. Dexmedetomidine did not increase incidence of postoperative sedation or postoperative nausea and vomiting.

Conclusions: Dexmedetomidine at a dose of 0.2 mcg/kg bolus and infusion, is equally efficacious as propofol boluses in maintaining mean arterial pressure within a range of 55 – 65 mm Hg. Heart rate control was better in dexmedetomidine group, requiring significantly lesser amount of beta blocker than propofol. Use of  Dexmedetomidine, even at this lower dose, significantly reduced the requirement of inhalational agent without increasing the incidence of sedation or postoperative nausea and vomiting.

 
Close