FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/03/031878 [Registered on: 10/03/2021] Trial Registered Prospectively
Last Modified On: 08/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE OBSERVATIONAL STUDY 
Study Design  Other 
Public Title of Study   Effect of fentanyl on propofol  
Scientific Title of Study   An entropy based observational study to determine the effect of varying time intervals between fentanyl and propofol administration on propofol requirement for induction of anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  CHETAN S 
Designation  POST GRADUATE RESIDENT 
Affiliation  KASTURBA MEDICAL COLLEGE, MANGALORE 
Address  Department of Anesthesiology Kmc attavar 6th floor Kasturba medical college mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9066301428  
Fax    
Email  schetan0201@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SURESH Y V 
Designation  Professor  
Affiliation  KASTURBA MEDICAL COLLEGE, MANGALORE 
Address  Department of anaesthesiology Kmc attavar 6th floor Kasturba medical college mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9845085108  
Fax    
Email  sureshyv63@gmail.com  
 
Details of Contact Person
Public Query
 
Name  CHETAN S 
Designation  POST GRADUATE RESIDENT 
Affiliation  KASTURBA MEDICAL COLLEGE, MANGALORE 
Address  Department of anaesthesiology Kmc hospital attavar 6th floor Kasturba medical college Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9066301428  
Fax    
Email  schetan0201@gmail.com  
 
Source of Monetary or Material Support  
Kmc hospital attavar mangalore 575001 
self 
 
Primary Sponsor  
Name  kasturba medical college mangalore 
Address  No:203, Light House Hill Rd, Hampankatta, Mangalore, Karnataka 575001 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
chetan s   kmc mens hostel kaprigudda attavara mangalore 
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 
chetan s  kasturba medical college hospital attavar  Department of anaesthesiology 6th floor kmc attavar Nandigudda Rd, Attavar, Mangalore, Karnataka 575001
Dakshina Kannada
KARNATAKA 
9066301428

schetan0201@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, KASTURBA MEDICAL COLLEGE, MANGALORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of age group between 18 years to 65 years, undergoing elective surgery under general anaesthesia under American Society of Anaesthesiologists physical status I-II. 
 
ExclusionCriteria 
Details  1. Patient refusing consent to participate in the study will not be included.
2. Patients with history of allergy to propofol or fentanyl.
3. Patients with BMI >30kg/m2.
4. Anticipated difficult airway.
5. Patients with respiratory, cerebrovascular, renal and cardiovascular diseases including hypertension.
6. Patients receiving any drugs likely to affect requirement of propofol and/or haemodynamic parameters.
7. Patients with history of alcohol or drug use, dehydration and emergency surgery are excluded from the study. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measures will be the total dose of propofol and the dose of propofol required in milligram per kg body weight for induction of anaesthesia.
 
0 , 3 min ,6 min according to the group 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome measures will be entropy values, SPO2, Heart rate, Systolic blood pressure, Diastolic blood pressure, Mean arterial pressure of the groups.  entropy values upto 10mins
other secondary outcomes till 30 min  
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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   N/A 
Date of First Enrollment (India)   18/03/2021 
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="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)?  

Response - NO
Brief Summary  
Written informed consent will be taken from all patients. All the patients will undergo a thorough pre anaesthetic evaluation and pre-operative orders will be given.
Then they will be assigned to three groups by convenience non probability sampling by the Anaesthesia consultant.
Group 1: patients who will be receiving propofol immediately after fentanyl injection.
Group 2: patients who will be receiving propofol 3 min after fentanyl injection.
Group 3: patients who will be receiving propofol 6 min after fentanyl injection.
In the operating room, standard pre induction monitors including electrocardiography, entropy monitor, pulse oximetry and non-invasive blood pressure will be attached and baseline heart rate, blood pressure, saturation, state entropy and response entropy will be recorded.
Intravenous fluid infusion will be started at a rate of 10 ml/kg/hour. Patients will be pre oxygenated with 100% oxygen. Intravenous fentanyl 2 mcg/kg will be administered as a bolus.
Subsequently, according to group, Group 1 patients will be administered propofol immediately after fentanyl injection, patients in Group 2 will receive propofol 3 minute after fentanyl injection, and
10
those in group 3 will be receiving propofol 6 min after the fentanyl injection by anaesthesia consultant. Patient will be monitored during and after administration of fentanyl.
Propofol will be injected slowly while communicating verbally with the patient. Induction of anaesthesia will be considered as complete when there is loss of response to verbal commands. Entropy value at this time is noted and will be recorded every minute until 10-minute post intubation. Patient will be monitored during and after propofol injection.
Spo2, Heart rate and Non-invasive blood pressure will be recorded every 2 min by the Anaesthesia postgraduate, from the time of fentanyl administration for 10 min and after that vitals will be recorded every 3 minutes.
The dose of propofol required for induction is noted. If any movement, vocalisation or bucking is noted at the initiation of mask ventilation, additional doses of propofol in aliquots of 20 mg will be administered by Anaesthesia consultant. The total dose requirement (induction dose plus additional boluses) will be also noted by the postgraduate. After confirmation of mask ventilation, rocuronium 0.6 mg/kg will be administered by the Anaesthesia consultant to facilitate tracheal intubation.
In case of hypotension – which is defined as fall of blood pressure of more than 20% from the baseline - an intravenous bolus of 300 ml of Ringer’s lactate will be administered.
Hypotension not responding to fluid bolus will be treated with a 100 mcg bolus of intravenous phenylephrine. Bradycardia-which is defined as fall in heart rate <50 or a rapidly falling heart rate, will be treated by 0.6mg bolus of intravenous atropine.
Occurrences of hypotension, bradycardia, and requirement of fluid boluses and vasopressors for treatment of hypotension will be recorded.
The following demographic parameters will be noted: age, sex, and weight and ASA physical status.
The primary outcome measures will be the total dose of propofol and the dose of propofol required in milligram per kg body weight for induction of anaesthesia.
Secondary outcome measures will be entropy values, SPO2, Heart rate, Systolic blood pressure, Diastolic blood pressure, Mean arterial pressure of the groups.
All interventions and entropy value interpretation will be done by Anaesthesia consultant.
All the data will be recorded by Anaesthesia postgraduate.

 
Close