| CTRI Number |
CTRI/2018/03/012353 [Registered on: 06/03/2018] Trial Registered Prospectively |
| Last Modified On: |
06/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effects of the two drugs dexmedetomidine and midazolam when given for spinal anaesthesia |
|
Scientific Title of Study
|
Comparison of dexmedetomidine and midazolam as adjuvants to 0.75% isobaric ropivacaine spinal anaesthesia in lower limb surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J Jancy |
| Designation |
PG Resident |
| Affiliation |
Ramaiah Medical College |
| Address |
Department of Anaesthesiology
Ramaiah Medical College
BEL Road
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9080112470 |
| Fax |
|
| Email |
jancyjoseph0601@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejesh C A |
| Designation |
Professor |
| Affiliation |
Ramaiah Medical College |
| Address |
Department of Anaesthesiology
Ramaiah Medical College
BEL Road
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
drtejeshca@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejesh C A |
| Designation |
Professor |
| Affiliation |
Ramaiah Medical College |
| Address |
Department of Anaesthesiology
Ramaiah Medical College
BEL Road
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
drtejeshca@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Ramaiah Medical College Hospital
BEL Road
Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr J Jancy |
| Address |
Department of Anaesthesiology
Ramaiah Medical College
Bangalore |
| Type of Sponsor |
Private medical college |
|
|
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 J Jancy |
Ramaiah Medical College Hospital |
Department of Anaesthesiology
Ramaiah Medical College
Bangalore
BEL ROAD
BANGALORE
Bangalore
KARNATAKA |
9080112470
jancyjoseph0601@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee MS Ramaiah Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with major co-morbid conditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
10mcg dexmedetomidine is added with 0.75% ropivacaine for spinal anaesthesia |
| Comparator Agent |
Midazolam |
2mg midazolam is added to 0.75% ropivacaine for spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Age 18-60 years.
2)American Society of Anaesthesiologists (ASA) Grade I and II.
|
|
| ExclusionCriteria |
| Details |
1)Patient refusal for subarachnoid block
2)Known allergy to the study drugs
3)Infection at the puncture site
4)Coagulation disorders
5)Neurological disorders
6)Hepatic and renal disorders
7)Use of antipsychotic medications
8)Body mass index ≥ 30kg/m2
9)Pregnancy & lactation
10)ASA ≥ III
|
|
|
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 |
| Onset and duration of sensory and motor block |
1)Onset of motor and sensory block will be assessed every 3min for the first 15 min after spinal anaesthesia.
2) Duration of motor and sensory block will be assessed at the end of surgery in the post operative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemodynamic stability
Duration of analgesia |
During the course of surgery
At the end of 24hr |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
20/03/2018 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Spinal anaesthesia is the commonly employed anaesthetic technique for lower limb surgeries. But it’s limitation is short duration of analgeisa. In order to extended the duration of block a number of agents are added along with local anaesthetic for spinal anaesthesia. Dexmedetomidine and midazolam are two such additives for spinal anaesthesia. In the present study we intend to compare dexmedetomidine and midazolam when added to spinal anaesthesia with 0.75% ropivacaine spinal anaesthesia. |