| CTRI Number |
CTRI/2013/03/003451 [Registered on: 04/03/2013] Trial Registered Retrospectively |
| Last Modified On: |
21/02/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To compare the effects of two drugs dexmedetomidine and fentanyl when used in spinal anaesthesia. |
|
Scientific Title of Study
|
Comparative study on the spinal block characteristics of intrathecal dexmedetomidine and fentanyl as adjuvants to bupivacaine. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR BINCY V THOMAS |
| Designation |
M. D Anaesthesia Student |
| Affiliation |
Government Medical College, Thiruvananthapuram |
| Address |
M.D Student,
Department Of Anaesthesia,
Government Medical College,
Thiruvananthapuram.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
09496826464 |
| Fax |
|
| Email |
bincyvthomas@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR LINETTE J MORRIS |
| Designation |
Professor |
| Affiliation |
Government Medical College, Thiruvananthapuram |
| Address |
Professor,
Department Of Anaesthesia,
Government Medical College,
Thiruvananthapuram.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
09447772436 |
| Fax |
|
| Email |
linettemorris5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BINCY V THOMAS |
| Designation |
M. D Anaesthesia Student |
| Affiliation |
Government Medical College, Thiruvananthapuram |
| Address |
M.D Student,
Department Of Anaesthesia,
Government Medical College,
Thiruvananthapuram.
KERALA
695011
India |
| Phone |
09496826464 |
| Fax |
|
| Email |
bincyvthomas@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 BINCY V THOMAS |
Department of Anaesthesia |
Govt. Medical College,
Thiruvananthapuram.
Thiruvananthapuram
KERALA |
09496826464
bincyvthomas@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee, Medical College, Thiruvananthapuram. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
comparing the effect of adding 2 drugs - dexmedetomidine and fentanyl on duration of spinal anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine |
5 microgram to be given intrathecally |
| Comparator Agent |
fentanyl |
25 microgram to be given intrathecally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 11 patients undergoing lower abdominal and genitourethral surgeries |
|
| ExclusionCriteria |
| Details |
Hypertension, cardiac diseases including conduction defects, contraindications to spinal anaesthesia, allergy to amide type of local anaesthetics or dexmedetomidine or fentanyl |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| difference between the duration of sensory blockade when dexmedetomidine and fentanyl are used as adjuvants to bupivacaine in spinal anaesthesia |
5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare motor block characteristics, sedation score and side effect profile of the two drugs in study. |
5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 |
|
|
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)
|
01/01/2013 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Spinal anaesthesia is very commonly used in lower abdominal and genitourethral surgeries as it is economical and easy to administer. But post operative pain relief is a major problem as local anaesthetics with short duration of action are used in spinal anaesthesia. Hence a number of adjuvants like clonidine, buprenorphine have been studied to prolong the duration of spinal anaesthesia.
The addition of fentanyl improves the quality of intraoperative and early postoperative subarachnoid block. But it has got disadvantages like nausea, vomiting, pruritus, respiratory depression etc.
Dexmedetomidine is an alpha 2 agonist which provides good quality of intraoperative and postoperative analgesia with minimal side effects. Based on earlier human studies, it is hypothesised that intrathecal 5 microgram dexmedetomidine would produce more postoperative analgesic effect with hyperbaric bupivacaine in spinal anaesthesia with minimal side effects.
|