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
|
|
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
|
|
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
|
|
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
|
|
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) |