| CTRI Number |
CTRI/2011/12/002186 [Registered on: 02/12/2011] Trial Registered Retrospectively |
| Last Modified On: |
15/09/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of dexmedetomidine as an adjuvant to bupivacaine in spinal anesthesia for lower abdominal surgery |
|
Scientific Title of Study
|
Clinical evaluation of dexmedetomidine as an adjuvant to bupivacaine in subarachnoid block for lower abdominal surgery:A randomized double blind controlled 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 Devayat Maru |
| Designation |
1ST Year resident in anaesthesiology. |
| Affiliation |
Government medical college and sir takhtsinhji general hospital |
| Address |
Department of Anaesthesiology,Govt.medical college & Sir T. general hospital.Bhavnagar-364001.
Bhavnagar
GUJARAT
364001
India |
| Phone |
919909975050 |
| Fax |
|
| Email |
devayat_maru2004@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDCTripathi |
| Designation |
Professor in department of anaesthesiology |
| Affiliation |
Government medical college and sir takhtsinhji general hospital bhavnagar |
| Address |
31/13, Shantinagar 2,
Kaliyabid
Bhavnagar
GUJARAT
364001
India |
| Phone |
09428408718 |
| Fax |
|
| Email |
drtripathi1961@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrDCTripathi |
| Designation |
Professor in department of anaesthesiology |
| Affiliation |
Government medical college and sir takhtsinhji general hospital, Bhavnagar |
| Address |
31/13, Shantinagar 2,
Kaliyabid
Bhavnagar
GUJARAT
364001
India |
| Phone |
09428408718 |
| Fax |
|
| Email |
drtripathi1961@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anasthesiology, Govt.medical college and sir Takhtsinhji general hospital, Bhavnagar-364001,Gujarat.India. |
|
|
Primary Sponsor
|
| Name |
Department Of Anasthesiology |
| Address |
Govt.Medical College And Sir Takhtsinhji General Hospital, Bhavnagar-364001,Gujarat.India. |
| Type of Sponsor |
Government 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 |
| DrDevayat RMaru |
Department of anaesthesiology |
Sir Takhtsinhji General Hospital,Bhavnagar-364001
Bhavnagar
GUJARAT |
09909975050
devayat_maru2004@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board, govt. medical college and sir takhtsinhji hospital.bhavnagar364001.gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Conditions requiring lower abdominal surgery i.e. Inguinal hernia, Open appendicectomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine + Distilled Water |
0.5% Of 2.5 ml Hyperbaric Bupivacaine + 0.5 ml Distilled Water, Single dose |
| Intervention |
Bupivacaine+Dexmeditomidine |
2.5ml 0.5%Hyperbaric Bupivacaine+0.5 Ml Distilled Water Containing 5 Microgram Dexmedetomedine, Single Dose |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1.Age: 30 to 60 years.
2.Sex: Male.
3.Patients posted for lower abdominal surgery; i. e. inguinal hernia repair and open appendicectomy.
4.Informed written consent for participation in study.
5.BMI 25 kg/m2.
|
|
| ExclusionCriteria |
| Details |
1. Uncontrolled or labile hypertension.
2. Contraindication to spinal anaesthesia.
3. Allergy to local anaesthetic or study drug.
4. Body mass index >25 kg/m2.
5. Patients taking any analgesics sedative or antihypertensive drugs.
6. Neurological disorders.
7. Psychiatric disorders.
8. Unco- operative patients.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset, Peak And Duration Of Sensory And Motor Block. |
0 min, 1 min, 2min, 3min, 5min, 10min, 15min,20min, 30min, 45min, 60min, 75min, 90min, 105min, 120min,135min, 150min,165min, 180min, 210min, 240min, 270min, 300min, 330min, 360min(6 hours), 8 hours, 10hours, 12hours, 14hours, 16hours, 20hours and 24hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post Operative Analgesia,Sedation And Complication If Any Withon 24 Hours Of Subarachnoid Block |
0 min, 1 min, 2min, 3min, 5min, 10min, 15min,20min, 30min, 45min, 60min, 75min, 90min, 105min, 120min,135min, 150min,165min, 180min, 210min, 240min, 270min, 300min, 330min, 360min(6 hours), 8 hours, 10hours, 12hours, 14hours, 16hours, 20hours and 24hours. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/08/2011 |
| 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="1"
Months="6"
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 an alpha-2 adrenergic receptor agonist recently introduced in indian market.
It has been used for premedication, as an adjuvant to general anaesthesia and for sedation in the intensive care unit. The aim of the present study is to evaluate the efficacy and safety of dexmedetomedine as an adjuvant to bupivacaine in subarachanoid block.
Study will be carried out in 100 ASA physical status 1 and 2 aged 30 to 60 years going to undergo elective lower abdominal surgery. Patient will be randomly allocated in 2 groups each of 50 by distributing sealed envelopes.1st group will be given bupivacaine and 2nd group will be given bupivacaine and dexmedetomidine in subarachnoid space. Patients will be assessed for onset, peak, duration and regression of sensory and motor block produced by boath groups. Sedation, analgesia, haemodynemic variables and complications will be recorded intraoperatively. Patients will be observed for 24 hours in post operative period. Data will be expressed as mean and standard deviation or numbers and percentages as applicable. Comparison between two groups will be done using unpaired t test for quantitative data and chi sqaure test for qualitative data. p value <0.05 is considered significant. |