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CTRI Number  CTRI/2018/12/016609 [Registered on: 11/12/2018] Trial Registered Prospectively
Last Modified On: 12/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical trial To compare the effect of dexmedetomidine and clonidine during laproscopic uterus removal operation under general anaesthesia. 
Scientific Title of Study   Comparative study of effect of dexmedetomidine versus clonidine on hemodynamic stability and postoperative analgesia during laproscopic assisted vaginal hysterectomy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHANMUGAVALLI E 
Designation  assistant professor 
Affiliation  Aarupadai veedu medical college and hospital. 
Address  department of anaesthesia, Aarupadai veedu medical college and hospital,puducherry.

Pondicherry
PONDICHERRY
607403
India 
Phone  9940882722  
Fax    
Email  vallijegan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SHANMUGAVALLI E 
Designation  assistant professor 
Affiliation  Aarupadai veedu medical college and hospital. 
Address  department of anaesthesia, Aarupadai veedu medical college and hospital,puducherry.

Pondicherry
PONDICHERRY
607403
India 
Phone  9940882722  
Fax    
Email  vallijegan@gmail.com  
 
Details of Contact Person
Public Query  
Name  SETHU MADHAVA KUMAR V 
Designation  assistant professor 
Affiliation  Velammal medical college and research institute 
Address  department of anaesthesia, Velammal medical college and research institute. madurai

Madurai
TAMIL NADU
625009
India 
Phone  9585442148  
Fax    
Email  sethuhareem@yahoo.co.in  
 
Source of Monetary or Material Support  
Self and Velammal Medical College Hospital and Research Institute,Madurai. 
 
Primary Sponsor  
Name  SHANMUGAVALLI E 
Address  department of anaesthesia, Aarupadai veedu medical college and hospital. pondicherry. 
Type of Sponsor  Other [self] 
 
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 
DrESHANMUGAVALLI  Velammal medical college hospital and research institute  No.21 ,Department of anaesthesia, Velammal medical college hospital and research institute,Madurai-625009 Madurai-625009.
Madurai
TAMIL NADU 		 9940882722

Vallijegan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VELAMMAL MEDICAL COLLEGE HOSPITAL AND RESEARH INSTITUE,INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj.clonidine 1 mcg/kg Inj.dexmedetomidine 1 mcg/kg.  General anaesthesia will be given for laparoscopic assisted vaginal hysterectomy. Group A will receive inj.dexmedetomidine 1 mcg/kg in normal saline a total volume of 50 ml before induction of anaesthesia. Group B will receive inj.clonidine 1 mcg/kg in normal saline a total volume of 50 ml before induction of anaesthesia.Hemodynamic response to pneumoperitoneum and post operative anagesic effect also will be studied and compared. 
Comparator Agent  Inj.clonidine 1 mcg/kg  General anaesthedia will be given for laparoscopic assisted vaginal hysterectomy. Group A Will receive inj.dexmedetomidine 1mcg/kg in normal saline a total volume of 50 ml Group B will receive inj.clonidine 1 mcg /kg in normal saline a total volume of 50 ml. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  ASA Physical status I and II.
Elective laparoscopic assisted vaginal hysterectomy. 
 
ExclusionCriteria 
Details  ASA physical status III,IV and V.
Patients with aortic stenosis.
Patient with history of congestive heart failure,liver disease,renal failure.
Patients with any degree of atrioventricular block.
Patients taking beta blocker and monoamine-oxidase inhibitors.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the outcome attenuation of hemodynamic response to pneumoperitonium and post operative analgesia during general anaesthesia in laparoscopic assisted general anaesthesia  Parameters like Heart rate,Systolic Blood pressure,Diastolic Blood pressure,Mean arterial Blood pressure and oxygen saturation are will be monitored at Baseline,Before induction,3 mins after Intubation,Before pneumoperitoneum,10 mins after pneumoperitoneum,then at every 30 mins interval till 180 mins.Along with this, above mentioned parameters will also be monitored 10 mins after pneumoperitoneum release and ten mins after extubation.VAS Pain Score will be monitored . 
 
Secondary Outcome  
Outcome  TimePoints 
HR,SBP,DBP,MAP ,Spo2,VAS score and complications like bradycardia and hypotension are monitored.  5 hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   25/12/2018 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
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   Randomized clinical trial to study the effect of intravenous dexmedetomidine and intravenous clonidine on hemodynamic response to pneumoperitoneum during general anaeshesia and post opeative analgesic effect in laparoscopic assisted vaginal hysterectomy. 
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