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 Modification(s)	DEXMEDETOMIDINE VERSUS CLONIDINE AS ADDITIVES AND THEIR CHARACTERISTICS ON SPINAL ANAESTHESIA IN A TERTIARY CARE HOSPITAL - CHENGALPATTU DISTRICT
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr M Murali Manoj  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 Contact Person Scientific Query	Name  Dr M Murali Manoj  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 Contact Person Public Query	Name  Dr M Murali Manoj  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 Modification(s)	Department Of Anaesthesiology Karpaga Vinayaga Institute Of Medical Sciences and Research Centre, GST Road, Chinna Kolambakkam, Palayanoor Post,Madhuranthakam Taluk, Chengalpattu District
Primary Sponsor Modification(s)	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	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  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   9791990979 mmm.slazenger@gmail.com
Details of Ethics Committee Modification(s)	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	Status  Not Applicable
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Patients  Medical and Surgical
Intervention / Comparator Agent Modification(s)	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 Modification(s)	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"
Phase of Trial	N/A
Date of First Enrollment (India) Modification(s)	15/09/2022
Date of First Enrollment (Global)	No Date Specified
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
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