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CTRI Number  CTRI/2017/11/010704 [Registered on: 29/11/2017] Trial Registered Retrospectively
Last Modified On: 22/11/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparing the effect of 4ml of 0.75% of isobaric Ropivacaine alone or with 5µg dexmedetomidine for abdominal hysterectomy Under spinal anesthesia 
Scientific Title of Study   Clinical Efficacy of Isobaric Ropivacaine 0.75%,4ml Alone and with Dexmedetomidine in Spinal Anaesthesia for Abdominal Hysterectomy: A Prospective Randomised Double Blind 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 BABU LAL JAT 
Designation  RESIDENT DOCTOR 
Affiliation  RNT MEDICAL COLLEGE UDAIPUR 
Address  DEPARTMENT OF ANAESTHESIA RNT MEDICAL COLLEGE UDAIPUR RAJASTHAN

Udaipur
RAJASTHAN
313001
India 
Phone  7742018002  
Fax    
Email  blghoshliya2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Devendra Verma 
Designation  Senior professor 
Affiliation  RNT Medical College Udaipur 
Address  Department Of Anaesthesia RNT Medical College Udaipur Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  9414289538  
Fax    
Email  devendra.anaes@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  DR BABU LAL JAT 
Designation  Resident Doctor 
Affiliation  RNT Medical College Udaipur 
Address  Department Of Anaesthesia RNT Medical College Udaipur Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  7742018002  
Fax    
Email  blghoshliya2@gmail.com  
 
Source of Monetary or Material Support  
RNT Medical College Udaipur 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NA] 
 
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 BABU LAL JAT  RNT Medical College And Attached Hospital Udaipur  Zanana Main OT Pannadhai Hospital Udaipur
Udaipur
RAJASTHAN 
7742018002

blghoshliya2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
R.N.T Medical College Controller Attached Hospitals Udaipur Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA GRADE 1 AND 2 All patients having age between 30 to 60 yr weight 40 to 80 kg and height more than 140cm will be included,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  All ASA GRADE 1 AND 2 patients having age between 30 to 60 year weight 40 to 80 kg and height more than 140cm will be included 
 
ExclusionCriteria 
Details  Patient refusal.
Contraindication to regional anaesthesia.
History of significant co-existing diseases like ischemic heart disease, hypertension, impaired renal functions, rheumatoid arthritis, severe liver disease and morbid obesity.
Atrio-ventricular block, incomplete or partial heart block.
Intake of α or β blockers.
Presence of anaemia, fused spine, coagulation disorder, diabetes, psychiatric illness, thyroid disease and malnourished patient,. Patient on any medication for systemic disease.
Allergy to amide local anaesthetics and dexmedetomidine.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical Efficacy of Isobaric Ropivacaine 0.75%,4ml Alone and with Dexmedetomidine in Spinal Anaesthesia for Abdominal Hysterectomy  six months period 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
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   N/A 
Date of First Enrollment (India)   01/05/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/05/2017 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Ropivacaine, first levo-isomer an amide local anaesthetic shares many physiochemical properties with bupivacaine but has shown a better safety profile over bupivacaine due to the reduced central nervous system and cardiac toxicity.(5,6) Recent clinical data have shown that ropivacaine is clinically effective and safe for regional anaesthetic techniques with good tolerability. Ropivacaine has been successfully used in spinal anaesthesia for caesarean section, urological surgery, and lower limb orthopedic surgery. However there is scarcity of data in which ropivacaine has been used in SAB for abdominal hysterectomy in which there is more extensive surgery, needing more relaxation than above mentioned surgeries. This prompted us to plan present study.When dexmedetomidine added to intrathecal ropivacaine better clinical profile was noted as compared to ropivacaine alone. However, no study comparing efficacy of ropivacaine 4ml of 0.75% versus ropivacaine 0.75% plus 5µg dexmetomedine in spinal anesthesia has been conducted to date.

 

                 Therefore we are planning present study using 4 ml of 0.75% ropivacaine alone and with 5µg dexmedetomidine   in spinal anesthesia for abdominal hysterectomy, to study sensory and motor block characteristics, success rate, postoperative analgesia, haemodynamic profile, and complications.

 Patients who will fulfill inclusion criteria will be enrolled in the study prior to enrolment written and informed consent will be taken. these patients will be randomly divided into two groups of 45 patients in each group using sealed envelope technique:

•   Group R: Patients will receive 4ml (30mg) of 0.75% Isobaric Ropivacaine hydrochloride.

•   Group RD: Patients will receive 4ml (30mg) of 0.75% Isobaric Ropivacaine with 5µg dexmedetomidine hydrochloride (0.05ml)

 

          
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