| CTRI Number |
CTRI/2022/09/045162 [Registered on: 01/09/2022] Trial Registered Prospectively |
| Last Modified On: |
10/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
DEXMEDETOMIDINE VERSUS CLONIDINE AS ADDITIVES AND THEIR CHARACTERISTICS ON SPINAL ANAESTHESIA - COMPARATIVE STUDY |
|
Scientific Title of Study
|
DEXMEDETOMIDINE VERSUS CLONIDINE AS ADDITIVES AND THEIR CHARACTERISTICS ON SPINAL ANAESTHESIA IN A TERTIARY CARE HOSPITAL - CHENGALPATTU DISTRICT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Murali Manoj |
| Designation |
Associate Professor |
| Affiliation |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre |
| Address |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre, GST Road, Chinnakolampakkam, Palayanur Post, Maduranthagam Post, Maduranthagam Taluk
Karpaga Vinayaga Institute of Medical Sciences and Research Centre, GST Road, Chinnakolampakkam, Palayanur Post, Maduranthagam Post, Maduranthagam Taluk
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
|
| Fax |
|
| Email |
mmm.slazenger@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Murali Manoj |
| Designation |
Associate Professor |
| Affiliation |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre |
| Address |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre, GST Road, Chinnakolampakkam, Palayanur Post, Maduranthagam Post, Maduranthagam Taluk
Karpaga Vinayaga Institute of Medical Sciences and Research Centre, GST Road, Chinnakolampakkam, Palayanur Post, Maduranthagam Post, Maduranthagam Taluk
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
|
| Fax |
|
| Email |
mmm.slazenger@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Murali Manoj |
| Designation |
Associate Professor |
| Affiliation |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre |
| Address |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre, GST Road, Chinnakolampakkam, Palayanur Post, Maduranthagam Post, Maduranthagam Taluk
Karpaga Vinayaga Institute of Medical Sciences and Research Centre, GST Road, Chinnakolampakkam, Palayanur Post, Maduranthagam Post, Maduranthagam Taluk
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
|
| Fax |
|
| Email |
mmm.slazenger@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre, GST Road, Chinna Kolambakkam, Palayanoor Post,Madhuranthakam Taluk, Chengalpattu District |
|
|
Primary Sponsor
|
| Name |
Dr M MURALI MANOJ |
| Address |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre, GST Road, Chinnakolampakkam, Palayanur Post, Maduranthagam Post, Maduranthagam Taluk |
| Type of Sponsor |
Other [] |
|
|
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 M Murali Manoj |
Karpaga Vinayaga Institute of Medical Sciences & Research Centre |
Department Of Anaesthesiology,
Karpaga Vinayaga Institute of Medical Sciences and Research Centre, GST Road, Chinnakolampakkam, Palayanur Post, Maduranthagam Post, Maduranthagam Taluk
Kancheepuram
TAMIL NADU |
9791990979
mmm.slazenger@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC(Human Studies) Karpaga Vinayaga Institute Of medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clonidine 50 microgram as a Sub Arachnoid Block Additive |
50 microgram,Intrathecal Intraoperative Sedation as a Sub Arachnoid Block Additive,
Hemaodyamic changes such as heart rate and blood pressure at 30,60,90,120,150,180,210,240 mins
First post operative rescue analgesic request or demand required at which post operative min to be noted.
Number of frequency of post operative rescue analgesics given after first post operative rescue analgesic demand or request till first 24 hrs |
| Comparator Agent |
Dexmeditomedine, 5microgram,Intrathecal |
Dexmeditomedine, 5microgram,Intrathecal as a Sub Arachnoid Block Additive
Intraoperative Sedation , Hemaodyamic changes such as heart rate and blood pressure at 30,60,90,120,150,180,210,240 mins
First post operative rescue analgesic request or demand required at which post operative min to be noted
Number of frequency of post operative rescue analgesics given after first post operative rescue analgesic demand or request till first 24 hrs |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Elective lower abdomen surgery to be carried out in sub arachnoid block belonging to American Society of Anesthesiologists Status I and II, surgeries having duration more than 2 hours. |
|
| ExclusionCriteria |
| Details |
Patient denial for sub arachanoid block and other contraindications, failed or patchy sub arachanoid block, individuals with labile hypertension |
|
|
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 and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset, duration, hemodynamic changes and level of sedation intra operatively will be compared. |
Onset, duration, hemodynamic changes and level of sedation intra operatively will be compared. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| subsequent dose consumptions of analgesia in both |
within first 24 hrs post operatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2022 |
| Date of Study Completion (India) |
16/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparing Dexmeditomedine and Clonidine in onset, duration, hemodynamic changes, level of sedation intraoperatively, post operative first rescue analgesic requirement and number of subsequent analgesic requirements when added as an additive to Sub Arachnaoid block |