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CTRI Number  CTRI/2021/08/035730 [Registered on: 17/08/2021] Trial Registered Prospectively
Last Modified On: 14/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A CLINICAL TRAIL TO STUDY THE ANALGESIC EFFICACY OF ORAL CLONIDINE VS INTRATHECAL CLONIDINE WHEN ADDED AS AN ADJUVANT TO 0.5% HYPERBARIC BUPIVACAINE IN CESAREAN SECTION. 
Scientific Title of Study   TO ASSESS THE ANALGESIC EFFICACY OF ORAL CLONIDINE VS INTRATHECAL CLONIDINE ADDED AS AN ADJUVANT TO 0.5% HYPERBARIC BUPIVACAINE IN CESAREAN SECTION --- A PROSPECTIVE RANDOMIZED DOUBLE BLIND CONTROLLED TRIAL. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vignesh T M 
Designation  Post graduate 
Affiliation  Karnataka institute of medical sciences 
Address  Room No:206, Department of Anesthesia KIMS Pb road, Vidhya nagar, Hubballi.

Dharwad
KARNATAKA
580032
India 
Phone  9524567167  
Fax    
Email  vickyvijay1995@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyothi B 
Designation  Professor 
Affiliation  Karnataka institute of medical sciences 
Address  Department of Anesthesia, Pb road, Vidhya nagar, Hubballi.

Dharwad
KARNATAKA
580032
India 
Phone  9886187056  
Fax    
Email  dr.jyothib1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jyothi B 
Designation  Professor 
Affiliation  Karnataka institute of medical sciences 
Address  Department of Anesthesia, Pb road, Vidhya nagar, Hubballi.

Dharwad
KARNATAKA
580032
India 
Phone  9886187056  
Fax    
Email  dr.jyothib1@gmail.com  
 
Source of Monetary or Material Support  
karnataka institute of medical sciences 
 
Primary Sponsor  
Name  Dr Vignesh T M 
Address  Room No,206 Department of anesthesia, KIMS, Pb road,Vidhya Nagar, Hubballi,Karnataka 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vignesh T M  Karnataka institute of medical sciences  Department of Anesthesia, KIMS,Pb road,Vidhya nagar, Hubballi.
Dharwad
KARNATAKA 		 9524567167

vickyvijay1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee,KIMS Hubballi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intrathecal clonidine as an adjuvant for 0.5% Hyperbaric bupivacaine   45 µg of clonidine intrathecally +0.5 % Hyperbaric bupivacaine 2cc(10mg)  
Comparator Agent  Oral clonidine as an adjuvant for 0.5% hyperbaric bupivacaine.  200µg oral clonidine + 0.5% hyperbaric bupivacaine 2cc(10mg)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  31.00 Year(s)
Gender  Female 
Details  ASA physical status â…  and â…¡.
Age 18-31 years.
Singleton pregnancy
Informed, written and valid consent.
 
 
ExclusionCriteria 
Details  Obstetric complications such as Placenta previa, Abruptio placenta and Preeclampsia.
Spinal deformity such as kyphoscoliosis.
BMI greater than 35kg/m2.
Height less than 150 cm or greater than180 cm.
Women with Hypertensive disorders,Cardiovascular disorders,Deep vein thrombosis.
Allergy to study drugs. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the duration of analgesia.  Duration of analgesia is assessed every 15 minutes from onset of sensory block to first request for rescue analgesic or VAS score 4 or more.  
 
Secondary Outcome  
Outcome  TimePoints 
Onset and duration of sensory block.
Onset and duration of motor block.
Hemodynamic changes
Fetal well being.


 		 Assessed every 15 minutes from onset of sensory block to regression of dermatome of two segments.
Degree of motor block checked every 5 mins for first 30mins.
Pulse, Blood pressure (mean), were recorded at 0 minute, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes after administration of Spinal anesthesia.
Fetal well being is assessed by APGAR scores at one minute and five minutes after birth.
 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 1 
Date of First Enrollment (India)   20/08/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is a randomized single centre trial comparing the effect of Intrathecal clonidine vs oral clonidine when added as an adjuvant to 0.5% hyperbaric bupivacaine in patients undergoing cesarean section, that will be conducted in a single centre in india. The primary objective is to measure the duration of analgesia. 
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