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CTRI Number  CTRI/2019/05/019257 [Registered on: 21/05/2019] Trial Registered Prospectively
Last Modified On: 26/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Effect of Dexmedetomidine Infusion on MAC of Isoflurane 
Scientific Title of Study   Effect of Dexmedetomidine infusion on Minimum Alveolar Concentration of Isoflurane And Quality of Surgical field in patients undergoing Middle ear surgery guided by Bispectral Index Analysis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jagruti Jagne 
Designation  Junior Resident Department of Anaesthesiology, LTMMC 
Affiliation  Lokmanya Tilak Municipal Medical college and General Hospital 
Address  Department of Anaesthesiology Lokmanya Tilak Muncipal Medical College and General hospital,Sion, Mumbai-400022. Mumbai MAHARASHTRA 400022 India

Mumbai
MAHARASHTRA
400022
India 
Phone  7875218754  
Fax    
Email  jagruti.jagne13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shailendra Dethe 
Designation  Assistant Professor, Department of Anaesthesiology 
Affiliation  Lokmanya Tilak Municipal Medical college and General Hospital 
Address  Department of Anaesthesiology Lokmanya Tilak Muncipal Medical College and General hospital,Sion, Mumbai-400022. Mumbai MAHARASHTRA 400022 India

Mumbai
MAHARASHTRA
400022
India 
Phone  9320329229  
Fax    
Email  shailendramodak@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shailendra Dethe 
Designation  Assistant Professor, Department of Anaesthesiology 
Affiliation  Lokmanya Tilak Municipal Medical college and General Hospital 
Address  Department of Anaesthesiology Lokmanya Tilak Muncipal Medical College and General hospital,Sion, Mumbai-400022. Mumbai MAHARASHTRA 400022 India

Mumbai
MAHARASHTRA
400022
India 
Phone  9320329229  
Fax    
Email  shailendramodak@yahoo.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal Medical College General Hospital Mumbai Maharashtra 400022 
 
Primary Sponsor  
Name  Lokmanya Tilak Municipal Medical college and General Hospital 
Address  Department of Anaesthesia LTMMC and LTMGH, Sion, Mumbai-400022 
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 Jagruti Jagne  Lokmanya Tilak Muncipal Medical college and General Hospital  Department of Anaesthesiology Lokmanya Tilak Muncipal Medical College and General hospital,Sion, Mumbai-400022. Mumbai MAHARASHTRA 400022 India
Mumbai
MAHARASHTRA 
7875218754

jagruti.jagne13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lokmanya Tilak Muncipal Medical college and General hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: H710||Cholesteatoma of attic,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. All adult patients ASA GRADE 1 and 2
2. Both gender
3. Patients undergoing middle ear surgery 
 
ExclusionCriteria 
Details  1. ASA 3 and more
2. Preoperative cardiac,respiratory and
neurological disorder
3. Drug allergy to any drug used in study
4. Patient with preoperative heart rate <60,
patient on beta blocker ,heart block
5. Pregnancy

























 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. Minimum alveolar concentration of isoflurane at BIS value of 45-60
2. Total consumption of isoflurane  
1. Baseline
2. Post induction
3. After every 10 mins
4. extubation 
 
Secondary Outcome  
Outcome  TimePoints 

1. Quality of surgical field
2. total dose of fentanyl used intraoperative  
1. After every half hour
2. Extubation 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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 4 
Date of First Enrollment (India)   15/07/2019 
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="2"
Months="2"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

After approval from institutional ethics committee patients fulfilling the inclusion criteria undergoing middle ear surgeries under general anaesthesia with or without dexmedetomidine will be observed.

After thorough preoperative evaluation, written informed consent will be obtained from the patients. Monitoring will include electrocardiography, pulse oximetry (SPo2), Etco2, NIBP, end tidal concentration of isoflurane, MAC of isoflurane and BIS. Baseline readings will be noted before premedication.

Routine induction protocol will be followed which will consists of premedication with Inj.Glycopyrrolate 0.04mg/kg, Inj.Midazolam0.02mg/kg, Inj.Fentanyl 2mcg/kg. This is then followed by induction with inj.Propofol 2-2.5mg/kg and Inj.Vecuronium 0.08-0.1mg/kg to facilitate tracheal intubation. Anesthesia is then maintained on isoflurane in O2 and Air (50:50) at flow rate of 4lit/minute with or without dexmedetomidine infusion in a loading dose of 1mcg/kg for 10minutes followed by a maintenance dose of 0.5mcg/kg. MAC of isoflurane at BIS value of 45-50 will be noted. At this time the dial concentration of isoflurane, end tidal concentration of isoflurane, inspired concentration of isoflurane will also be noted. Flow rates of gases are then decreased to 2lit/min. MAC of isoflurane at BIS value of 45-50, inspired concentration of isoflurane, end tidal concentration of isoflurane will be noted down every 10 minutes. 

Muscle relaxation during surgery is maintained on intermittent doses of Inj.Vecuronium. 

Any increase in heart rate and MAP of more 20% from the baseline despite keeping the BIS of 45-50 will be noted and treatment given will be noted. Any decrease in heart rate and MAP of more than 20%will be noted and treatment given for it will be noted.

Intraoperative quality of surgical field will be evaluated using a Fromme’s bleeding score which is as follows. (12) 

Table showing the bleeding score.

Grade

Parameter/Observation

 

Grade 0

No bleeding

 

Grade 1

Slight     bleeding-             No                 suction required

 

Grade 2

Slight bleeding- Occasional suctioning required

 

Grade 3

Slight     bleeding-Frequent suctioning required

 

Grade 4

Moderate bleeding-Frequent suctioning required.Bleeding threatens the surgical field immediately after suction is removed.  

 

Grade 5

Severe bleeding-Constant suctioning required. Bleeding appears faster than that can be removed by suction. Surgery is impossible.

 

A category scale values of 2 and 3 in the score is considered ideal.

 

 Dexmedetomidine infusion is stopped 30 minutes before completion of surgery. Isoflurane is stopped 20 minutes before completion of surgery. At the end of surgery routine extubation protocol will be followed.MAC of isoflurane when the patient becomes responsive to command will be noted. Time from discontinuation of dexmedetomidine infusion to responsiveness to oral commands will be noted. Time required to achieve BIS of 90 will also be noted. Total dose of fentanyl required will be noted.

 

Total consumption of isoflurane will be noted using Dion’s formula.

 

Parameters to be studied.

 

1)  Minimum alveolar concentration of isoflurane at BIS value of 45-50

2)  Fraction of inspired concentration of isoflurane

3)  End tidal concentration of isoflurane

4)  Quality of surgical field

5)  Total dose of intraoperative fentanyl

6)  Total consumption of isoflurane 

Total consumption of isoflurane will be calculated using Dion’s formula (13)

Fresh gas flow(lit permin )×dial concentration(%)×1000 isoflurane fluid volume(ml)= ×Period of each instance.

Conversion factor

 

A conversion factor is the amount of volatile agent vapour derived from 1 ml of fluid agent.

 

 
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