| CTRI Number |
CTRI/2014/04/004535 [Registered on: 09/04/2014] Trial Registered Retrospectively |
| Last Modified On: |
15/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Dexmedetomidine versus midazolam, when both are given intravenously,as supplementation to Ropivacaine Spinal
Anaesthesia |
|
Scientific Title of Study
|
Comparison of intravenous Dexmedetomidine with Midazolam in prolonging spinal anaesthesia with Ropivacaine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Arora |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Rajindra Hospital, Patiala |
| Address |
C/o Department of Anaethesia and Intensive care, Government Medical college, Rajindra Hospital, Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9216265088 |
| Fax |
|
| Email |
drdivyaarora86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tarlochan Singh Punia |
| Designation |
Professor and Head of department |
| Affiliation |
Government Medical College, Rajindra Hospital, Patiala |
| Address |
Department of Anaethesia and Intensive care, Government Medical college, Rajindra Hospital, Patiala
Department of Anaethesia and Intensive care, Government Medical college, Rajindra Hospital, Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9216323131 |
| Fax |
|
| Email |
tspunia@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Arora |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Rajindra Hospital, Patiala |
| Address |
C/o Department of Anaethesia and Intensive care, Government Medical college, Rajindra Hospital, Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9216265088 |
| Fax |
|
| Email |
drdivyaarora86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College,Patiala |
|
|
Primary Sponsor
|
| Name |
Dr T S Punia |
| Address |
Professor and Head of Department, Department of anaesthesia and Intensive care, Rajindra Hospital, Patiala |
| Type of Sponsor |
Other [Head of Department] |
|
|
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 Divya Arora |
Operation Theatre complex of Rajindra Hospital, Patiala |
c/o Dept. of Anesthesia And Intensive Care,Government Medical College,Rajindra Hospital Patiala
Patiala
Patiala
PUNJAB |
9216265088
drdivyaarora86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee, Government Medical College, Rajindra Hospital, Patiala, affiliated to Baba Farid University Of Health Sciences, Faridkot. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing lower limb and lower abdominal surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ropivacaine |
Group C patients given 3 ml of Ropivacaine0.5%(15mg) Frequency- single shot, Route- Intrathecal ;
Normal saline given intravenously |
| Intervention |
Ropivacaine with dexmedetomidine |
Group D patients given 3 ml of Ropivacaine 0.5%
(15mg) , Frequency- single shot, Route- Intrathecal ;
Dexmedetomidine Dose- 1mcg/kg as loading dose , followed by 0.5mcg/kg/hr , Frequency-Continuous infusion , Route- Intravenous
|
| Intervention |
Ropivacaine with Midazolam |
Group M patients given 3 ml of Ropivacaine 0.5% (15mg) , Frequency- single shot, Route- Intrathecal ; Midazolam Dose- 0.05mg/kg as loading dose , followed by 0.02mg/kg/hr , Frequency-Continuous infusion , Route- Intravenous |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II
Patients undergoing lower limb and lower abdominal surgery
Body mass index of 30 or less
Normal coagulation profile |
|
| ExclusionCriteria |
| Details |
Unwilling patient, history of chronic illness, spinal abnormality, local skin infection, coagulation defects, Recent MI, Allergy to the drugs being used |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time for onset of analgesia ( highest level assessed by bilateral pin prick )
Peak sensory level reached
Time taken for sensory block regression by 2 dermatomes, Time taken for motor block to recede to Bromage and Postoperative
Sedation produced by the two groups,
Haemodynamic profile of the two groups ,
Need of additional analgesic
, Incidence of complications including depression, nausea, vomiting, pruritus, hypotension, bradycardia, shivering between the two groups |
Intraoperative ,Intraoperative, Postoperative, Postoperative, Intraoperative, every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative, Intraoperative and Postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time for onset of analgesia ( highest level assessed by bilateral pin prick )
Peak sensory level reached, Time taken for motor block to recede to Bromage and Postoperative
Sedation produced by the two groups,
Haemodynamic profile of the two groups ,
, Incidence of complications including depression, nausea, vomiting, pruritus, hypotension, bradycardia, shivering between the two groups |
Intraoperative,Intraoperative,Postoperative, Intraoperative ,Intraoperatively every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative and Postoperative |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/09/2012 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
paper published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In the present clinical study, we compare the effects of intravenous dexmedetomidine with midazolam on spinal block duration, sedation and post operative analgesia. Whereas Midazolam is only a sedative, Dexmedetomidine has both analgesic and sedative properties that may prolong the duration of sensory and motor block obtained with spinal anaesthesia. 60 ASA grade I & II patients scheduled for lower limb and lower abdominal surgeries in Govt. Medical college/Rajindra hospital, Patiala will be randomly allocated to three groups of 20 each. Immediately after 3ml of 0.5% ropivacaine given intrathecally, Group D (n=20): will be administered i/v dexmedetomidine (a loading dose of 1 µg/kg over 10 min and a maintenance dose of 0.5 µg/kg/hr in form of infusion) Group M (n=20): will be given midazolam (loading dose of 0.05 mg/kg followed by infusion@0.02 mg/kg/hour), and , Group C (n=20): will receive the normal saline. Intraoperative haemodynamic changes, onset, level & duration of sensory block, onset and duration of motor block, level of sedation, postoperative analgesia & side effects, if any will be recorded. All findings and information, including the time for the first request for postoperative analgesia and the number of patients requiring supplemental analgesia will be recorded. All results will be analysed statistically. |