| CTRI Number |
CTRI/2015/01/005431 [Registered on: 20/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
12/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Studying the effect of intravenous dexmedetomidine on spinal anaesthesia with bupivacaine. Dexmedetomidine is an alpha agonist drug known to prolong the effects of spinal anaesthesia. Bupivacaine is a local anaesthetic. |
|
Scientific Title of Study
|
Effect of intravenous dexmedetomidine administered as bolus or bolus plus infusion on subarachnoid block with hyperbaric bupivacaine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavya R Upadhya |
| Designation |
Junior Resident,Department of Anaesthesia |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986245389 |
| Fax |
|
| Email |
kavya.upadhya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramkumar Venkateswaran |
| Designation |
Professor, Department of Anaesthesia |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9480575003 |
| Fax |
|
| Email |
rvenkateswaran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavya R Upadhya |
| Designation |
Junior Resident,Department of Anaesthesia |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986245389 |
| Fax |
|
| Email |
kavya.upadhya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal University |
| Address |
KMC, Manipal, Udupi District-576104 |
| 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 |
| Kavya R Upadhya |
Kasturba Medical College |
Main Operation Theatre Complex,1st Floor, Department of Anaesthesiology, Kasturba Medical College, Manipal.
Udupi
KARNATAKA |
9986245389
kavya.upadhya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
American Society of Anaesthesiologists Physical Status 1 or 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group BDexB
|
receives dexmedetomidine 1 ug/kg rounded to the nearest 10 ug in 20 ml 0.9 % NaCl first 10 mins, followed by spinal anaesthesia and then 20 ml 0.9 % NaCl over next 60 mins. |
| Intervention |
Group BDexBI
|
half of calculated dose of dexmedetomidine (total dose is 1 ug/kg )in 20 ml 0.9% NaCl given over first 10 mins followed by spinal anaesthesia. remaining half of calculated dose of dexmedetomidine in 20 ml 0.9 % NaCl given over next 60 mins. |
| Comparator Agent |
saline group-group B |
receives 20 ml saline(0.9% NaCl) bolus 10 mins prior to subarachnoid anaesthesia and later 20 ml saline infusion over 60 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing elective infraumbilical or lower limb surgery in the supine position under spinal anaesthesia belonging to american society of anaesthesiologists physical status 1 or 2. |
|
| ExclusionCriteria |
| Details |
Patients who do not consent for subarachnoid anaesthesia
Patients with coagulopathy, hypovolaemia,
BMI > 35 kg/m2, spinal abnormalities
Chronic use of sedatives or antidepressants
History of regular alcohol consumption
Local infection over lumbar spine
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
onset of analgesia at T10.
highest level of analgesia.
2 segment regression.
recovery at S2-3.
onset of motor block and recovery .
sedation score. |
onset of analgesia at T10.sensory level then checked every 2 mins till
highest level of analgesia achieved then every 5 mins till end of 1 hr and every 15 mins till
2 segment regression, recovery.
time of recovery at S2-3.
motor blockade assessed using modified bromage score.onset time is when bromage score of 3 is obtained and motor recovery when modified score is 0.
sedation score.sedation score recorded using ramsay sedation score every 15 mins throughout first 3 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| haemodynamic parameters-blood pressure, heart rate, saturation. other side effects like nausea, vomiting or pruritus |
BP and heart rate every 2.5 mins for first 15 mins.then 5 mins for first hour and then every 15 mins till complete recovery. |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/06/2014 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Dexmedetomidine is a highly selective alpha2 agonist and studies have shown that it prolongs motor, sensory blockade during spinal anaesthesia without undesirable side effects. The aim of our study is to compare the effect of 1 ug/kg of intravenous dexmedetomidine, given either as a bolus(1 ug/kg) or bolus plus infusion(0.5 ug/kg) on subarachnoid anaesthesia with 12.5 mg of hyperbaric bupivacaine(2.5 ml of 0.5 % bupivacaine). observer 1 is the anaesthesia faculty who will prepare the drug dilutions and observer 2 is the postgraduate(principal investigator, blinded to the study ) who will administer subarachnoid anaesthesia, record the parameters and any complications during the study. On the day of surgey the patients are allocated into one of the 3 groups as per randomisation table.After shifting to the ot, monitors are attached, iv line secured and drugs will be administered as described previously. All the parameters are then recorded till both sensory and motor recovery.
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