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
|
|
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
|
|
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. |