| CTRI Number |
CTRI/2019/02/017764 [Registered on: 21/02/2019] Trial Registered Prospectively |
| Last Modified On: |
21/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Iam comparing two drugs(dexmedetomidine,fentanyl)in spinal anaesthesia for pain relief after operation in patients who were operated below umbilicus. |
|
Scientific Title of Study
|
Comparative study of intrathecal dexmedetomidine &fentanyl as adjuvant to hyperbaric bupivacaine and hyperbaric bupivacaine alone in infraumbilical surgeries -prospective randomized controlled study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P D N JYOTHI |
| Designation |
DNB ANAESTHESIA PRIMARY PG |
| Affiliation |
Sri rama krishna hospital,Coimbatore |
| Address |
SRI RAMA KRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,SIDHAPUDUR,COIMBATORE-641044
SRI RAMA KRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,SIDHAPUDUR,COIMBATORE-641044
Coimbatore
TAMIL NADU
641044
India |
| Phone |
8978453527 |
| Fax |
|
| Email |
jyothipdn2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drmuthu kumar |
| Designation |
MBBS,DNB ANAESTHESIA,PDCC(cardiac anaesthesia) |
| Affiliation |
Sri rama krishna hospital,Coimbatore |
| Address |
SRI RAMA KRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,SIDHAPUDUR,COIMBATORE-641044
SRI RAMA KRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,SIDHAPUDUR,COIMBATORE-641044
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9843505970 |
| Fax |
|
| Email |
muthu74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
P D N JYOTHI |
| Designation |
DNB ANAESTHESIA PRIMARY PG |
| Affiliation |
Sri rama krishna hospital,Coimbatore |
| Address |
SRI RAMA KRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,SIDHAPUDUR,COIMBATORE-641044
SRI RAMA KRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,SIDHAPUDUR,COIMBATORE-641044
Coimbatore
TAMIL NADU
641044
India |
| Phone |
8978453527 |
| Fax |
|
| Email |
jyothipdn2@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI RAMA KRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,SIDHAPUDUR,COIMBATORE-641044 |
|
|
Primary Sponsor
|
| Name |
P D N JYOTHI |
| Address |
SRI RAMA KRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,SIDHAPUDUR,COIMBATORE-641044 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| P D N JYOTHI |
Sri rama krishna hospital |
SRI RAMA KRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,SIDHAPUDUR,COIMBATORE-641044
Coimbatore
TAMIL NADU |
8978453527
jyothipdn2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri rama krishna hospital ethical committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Randomized controlled trial |
Comparing dexmedetomidine 10 micrograms and fentanyl 25 micrograms as adjuvant to hyperbaric bupivacaine 12.5mg by taking plain bupivacaine 12.5mg as control group intrathecally in patients undergoing infra umbilical surgeries. |
| Comparator Agent |
Randomized controlled trial |
Comparing dexmedetomidine 10micrograms and fentanyl 25 micrograms as adjuvant to bupivacaine12.5mg by taking plain bupivacaine12.5mg as control group intrathecally in patients undergoing infra umbilical surgeries. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 18 to 60 years
2. ASA 1 or 2
3. Presenting for infra umbilical surgeries |
|
| ExclusionCriteria |
| Details |
1.Patient allergic to drug
2. ASA 3 and 4( uncontrolled diabetes, uncontrolled hypertension, heart blocks, IHD patients)
3.Any contraindications to subarchnoid block. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Primary aim is to compare the duration of postoperative analgesia of dexmedetomidine and fentanyl given as adjuvants intrathecally to hyperbaric bupivacaine and hyperbaric bupivacaine alone |
2nd hourly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary aim will be to compare the onset of sensory and motor block, hemodynamic changes like bradycardia and hypotension of dexmedetomidine and fentanyl given intrathecally with hyperbaric bupivacaine and hyperbaric bupivacaine alone. |
Every 2min |
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
12/03/2019 |
| 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="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)?
|
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Brief Summary
|
Various adjuvants have been used with local anaesthetics in spinal anaesthesia to avoid intraoperative visceral and somatic pain and to provide prolonged postoperative analgesia. Aim: aim of this study is to compare postoperative analgesia duration,onset of sensory and motor block,hemodynamic changes (bradycardia,hypotension) of dexmedetomidine,fentanyl given intrathecally with bupivacaine and bupivacaine alone. Materials and methods: 90 patients classified in American society of anesthesiologists classes 1 and 2 scheduled for infraumbilical surgeries will be studied.patients will be randomly allocated to receive 12.5mg hyperbaric bupivacine plus 10 microgram(group D,n=30) or hyperbaric bupivacine 12.5mg plus fentanyl 25micrograms (group F,n=30) or hyperbaric bupivacaine alone (group c,n=30)intrathecally.
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