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CTRI Number  CTRI/2019/07/019958 [Registered on: 01/07/2019] Trial Registered Prospectively
Last Modified On: 15/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of two drugs,Dexmedetomidine and Fentanyl during pneumoperitonium in laproscopic cholecystectomy. 
Scientific Title of Study   Comparison of effectiveness of intravenous Dexmedetomidine vs fentanyl for attenuation of hemodynamic response to pneumoperitonium in laparoscopic cholecystectomy at SMS College Jaipur During 2018-19: A randomised double blind interventional 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 REEMA MEENA 
Designation  PHOD 
Affiliation  Department of Anaesthesiology,SMS MEDICAL COLLEGE,JAIPUR 
Address  Department of Anaesthesiology,2nd floor,Dhanwantari building,SMS MEDICAL COLLEGE,JAIPUR

Jaipur
RAJASTHAN
302004
India 
Phone  9413237117  
Fax    
Email  reemadrrn@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR REEMA MEENA 
Designation  PHOD 
Affiliation  Department of Anaesthesiology,SMS MEDICAL COLLEGE,JAIPUR 
Address  Department of Anaesthesiology,2nd floor,Dhanwantari building,SMS Medical College,JAIPUR

Jaipur
RAJASTHAN
302004
India 
Phone  9413237117  
Fax    
Email  reemadrrn@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR CHANDRAKANT PARASHAR 
Designation  PG STUDENT 
Affiliation  Department of Anaesthesiology,SMS MEDICAL COLLEGE,JAIPUR 
Address  Department of Anaesthesiology,2nd floor,Dhanwantari building,SMS Medical C0llege,JAIPUR

Jaipur
RAJASTHAN
302004
India 
Phone  8233257049  
Fax    
Email  parashar3800@rocketmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology,SMS Medical College,JLN Marg,JAIPUR(RAJASTHAN) PIN 302004 
 
Primary Sponsor  
Name  Department of Anaesthesiology Medical CollegeJaipur 
Address  JLN Marg,Jaipur(RAJASTHAN) 302004 
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 REEMA MEENA  SMS MEDICAL COLLEGE,Jaipur  Department of Anaesthesiology,SMS MEDICAL COLLEGE,JLN marg,JAIPUR 302004
Jaipur
RAJASTHAN 		 9413237117

reemadrrn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMS MEDICAL COLLEGE ETHICS COMMITTEE,JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IV INJ. Dexmedetomidine  42 patients will receive inj. Dexmedetomidine 1mcg/kg IV diluted with normal saline to make a total volume of 10 ml and injected IV slowly over 10 minute.followed by infusion at the rate of 0.2 μg/kg/hr. 
Intervention  IV inj. Fentanyl   42 patients will receive inj. Fentanyl 1mcg/kg IV diluted with normal saline to make a total volume of 10 ml and injected IV slowly over 10 minute. followed by infusion at the rate of 0.2 μg/kg/hr.  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patients with ASA grade I and II
2.Patients willing to give written informed consent.
3.Age Groups 18 to 50 years
4.Weighing 40 to 70 kg.
5.Scheduled for elective laparoscopic cholecystectomy
 
 
ExclusionCriteria 
Details  1.Patients not willing to participate in study
2.Patients having history of allergy to anaesthestic agents used in study
3.Patients with pre-existing cardiac disease, Hypertension ,Asthama,Renal or Hepatic dysfunction
4.Patients with anticipated difficult intubation i.e Mallampati class 3 or more,restricted neck movement or restricted mouth opening.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the change in hemodynamic variables (HR,SBP,DBP,MAP) after pneumoperitoneum in both the study groups.

 		 Data will be recorded Just Before induction,1min after induction,1 min after intubation,3min after intubation,1min after PNP and 10min interval in PNP throughout the surgery and after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess and compare the duration of post operative analgesia in both the study groups.
2. To determine post-operative sedation level in both the study groups.
3. To determine the incidence of side effects if any in both the study groups. 		 Post-operative sedation level will be measured by using RAMSAY SEDATION SCORE in every 30min. after extubation.POST-OPERATIVE ANALGESIA Evaluated by Visual analogue scale(VAS) in every 30min. upto Giving First Rescue Analgesia.
 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/07/2019 
Date of Study Completion (India) 02/12/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
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   Dexmedetomidine is a highily selective alpha2 agonist that provides anxiolysis,analgesia and cooperative sedation without respiratory depression.Fentanyl is a potent synthetic mu receptor opoid agonist that produces dose dependent analgesia and sedation. In this study we aim to compare the effectiveness of inj.Dexmedetomidine Vs inj.Fentanyl  for attenuation of hemodynamic response to pneumoperitonium in laproscopic cholecystectomy.We hypothesize that Dexmedetomine would be better  in controlling haemodynamic parameters and pain then in Fentanyl. 
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