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CTRI Number  CTRI/2016/01/006519 [Registered on: 14/01/2016] Trial Registered Retrospectively
Last Modified On: 13/01/2016
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 THREE DIFFERENT DOSES OF FENTANYL TO PREVENT HEMODYNAMIC STRESS RESPONSE DURING INTUBATION 
Scientific Title of Study   “CLINICAL EVALUATION OF EFFICACY AND SAFETY OF THREE DIFFERENT DOSES OF FENTANYL TO PREVENT HAEMODYNAMIC STRESS RESPONSE DURING LARYNGOSCOPY AND INTUBATION: A RANDOMIZED DOUBLE BLIND CLINICAL 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 MANOJ KUMAR 
Designation  RESIDENT 
Affiliation  GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHAJI GENERAL HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIA GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHAJI GENERAL HOSPITAL BHAVNAGAR

Bhavnagar
GUJARAT
380007
India 
Phone  7046482085  
Fax    
Email  DRMANOJRIMS@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  DR DCTRIPATHI 
Designation  PROFESSOR AND HOD 
Affiliation  GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHAJI GENERAL HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIA GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHAJI GENERAL HOSPITAL BHAVNAGAR

Bhavnagar
GUJARAT
380007
India 
Phone  9428408718  
Fax    
Email  drtripathi1961@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DR DCTRIPATHI 
Designation  PROFESSOR AND HOD 
Affiliation  GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHAJI GENERAL HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIA GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHAJI GENERAL HOSPITAL BHAVNAGAR


GUJARAT
380007
India 
Phone  9428408718  
Fax    
Email  drtripathi1961@yahoo.co.in  
 
Source of Monetary or Material Support  
GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHAJI GENERAL HOSPITAL 
 
Primary Sponsor  
Name  GOVERNMENT MEDICAL COLLEGE 
Address  GOVERNMENT MEDICAL COLLEGE AND SIR TAKHTSINHAJI GENERAL HOSPITAL BHAVNAGAR GUJARAT 
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 
manoj kumar  government medical college bhavnagar  department of anaesthesia government medical college bhavnagar
Bhavnagar
GUJARAT 
7046482085

drmanojrims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD(HUMAN ETHICS COMMITTEE)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  POSTED FOR ELECTIVE SURGERY,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  inj fentanyl  2mcg/kg,3mcg/kg and 4mcg/kg of fentanyl intravenously as a sigle dose five minute before induction of anaesthesia. 
Intervention  inj.fentanyl  2mcg/kg,3mcg/kg,and 4mcg/kg of fentanyl intravenously as a sigle dose five minute before induction of anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  • Age: 18 to 40 years.
• Gender: Either gender.
• Patients posted for elective surgery under general anaesthesia requiring endotracheal intubation.
• Duration of surgery up to 2 hrs.
• ASA physical status I and II.
• BMI ≤ 25kg/m2.
• Informed written consent for participation in study.
 
 
ExclusionCriteria 
Details  • Patients with diabetes, COPD, renal disease, cardiac diseases like IHD, hypertension, valvular heart disease, AV conduction block, aortic stenosis, left ventricular failure, etc.
• Patients on drugs having effects on heart rate and blood pressure (sedatives, opioids, β-blockers, calcium channel blockers, diuretics) and anti-psychiatric drugs.
• Pregnant women and lactating mothers.
• Anticipated difficult intubation.
• Intubation attempt lasting longer than 15 seconds.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess the efficacy and safety of three different doses of fentanyl in attenuating haemodynamic stress response to laryngoscopy and endotracheal intubation.  at baseline, 5minutes after fentanyl administration, at the time of intubation, and then at 1,3,5,10,15 and 20 minutes after intubation.  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the sedative effect of fentanyl.
2. To observe complication if any, in three groups.
 
at baseline, 5minutes after fentanyl administration, at the time of intubation, and then at 1,3,5,10,15 and 20 minutes after intubation,intraoperative period,at the time of extubation and postoperative upto 120 minutes 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   08/04/2015 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

To assess the efficacy and safety of three different doses of fentanyl in attenuating haemodynamic stress response to laryngoscopy and endotracheal intubation. To assess the sedative effect of fentanyl.To observe complication if any, in three groups.

 After approval from the institutional review board (IRB No. 504/2015) and informed written consent from patient, this prospective, randomized, double blind clinical study was carried out in 90 patients of either gender aged 18 to 40 years of ASA Physical status I and II scheduled for elective surgery under general anaesthesia requiring endotracheal intubation were enrolled in this study. After thorough preanaesthetic evaluation, patients with cardio respiratory diseases, diseases affecting autonomic system, taking medication affecting hemodynamic variables and sedation score, anticipated difficult intubation and Intubation attempt lasting longer than 15 seconds and antenatal females and body mass index more than 25 were excluded from study.   Patients were fasted for 6 hours before surgery. In pre-anaesthetic preparation    room monitoring for Heart Rate (HR), Non Invasive Blood Pressure (systolic, diastolic and mean arterial pressure) and peripheral oxygen saturation (SpO2), were established and baseline vital parameters were recorded.Patients were randomly divided into three groups 30 patients of each using computer generated random number sequence. Fentanyl in the doses of 2mcg/kg, 3mcg/kg and 4mcg/kg   intravenously was given 5 minutes before induction of anaesthesia in group I, II and III respectively.All patients received a standard anaesthetic protocol. All the parameters selected (HR, SBP, DBP, MAP) were recorded at various specific timings-at baseline, 5minutes after fentanyl administration, at the time of intubation, and then at 1,3,5,10,15 and 20 minutes after intubation.At the end of surgery, neuromuscular blockade was reversed with neostigmine 50µg/kg and glycopyrrolate 10µg/kg intravenously. After satisfying the extubation criteria, trachea was extubated and patients were transferred to post anaesthesia care unit. Sedation score was recorded at base line, 5 minutes after fentanyl injection, at the time of extubation, and then at 5,10,15,20,30,60,90 and 120 minutes after extubation in the postoperative period.

 

    

 

 
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