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CTRI Number  CTRI/2023/10/059020 [Registered on: 23/10/2023] Trial Registered Prospectively
Last Modified On: 21/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   comparison between 2 drugs in gynecological surgery 
Scientific Title of Study   A Comparison of Intrathecal Clonidine versus Dexmedetomidine versus 0.9% Saline as Adjuvants to 0.5% Hyperbaric Bupivacaine in Elective Gynecological Surgery.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SOMSUNDAR R G  
Designation  Assistant Professor 
Affiliation  Mandya Institute Of Medical Sciences 
Address  Department Of anaesthesiology Mandya Institute Of Medical Sciences Mandya

Mandya
KARNATAKA
571401
India 
Phone  9686508877  
Fax    
Email  somurg@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SOMSUNDAR R G  
Designation  Assistant Professor 
Affiliation  Mandya Institute Of Medical Sciences 
Address  Department Of Anaesthesiology Mandya Institute Of Medical Sciences Mandya

Mandya
KARNATAKA
571401
India 
Phone  9686508877  
Fax    
Email  somurg@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR Sharmila Sherin 
Designation  Post Graduate Student 
Affiliation  Mandya Institute Of Medical Sciences 
Address  Department Of Anaesthesiology Mandya Institute Of Medical Sciences Mandya

Mandya
KARNATAKA
571401
India 
Phone    
Fax    
Email  drsharmilasherin@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  DR SOMSUNDAR R G  
Address  Department Of Anaesthesiology Mandya Institute Of Medical Sciences Mandya -571401 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
DR SHARMILA SHERIN  DEPARTMENT OF ANAESTHESIOLOGY MANDYA INSTITUTE OF MEDICAL SCIENCES MANDYA -571401 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Sharmila Sherin  Mims , Mandya  Department Of Anaesthesiology Mandya Institute Of Medical Sciences Mandya
Mandya
KARNATAKA 		 9483921926

drsharmilasherin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE, MANDYA INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.5% Bupivacaine 17.5mg (3.5ml) with 50µg Clonidine   0.5% bupivacaine 17.5mg (3.5ml) with 50µg Clonidine (in 0.5ml normal saline) (Total volume-4ml) . The sensory block level will be assessed using loss of sensation to pinprick along the midclavicular line bilaterally and the higher level will be used for statistical purposes if the levels are not the same bilaterally. The motor block will be assessed using modified Bromage scale 
Comparator Agent  : 0.5% bupivacaine 17.5mg (3.5ml) with 5 µg Dexmedetomidine (in 0.5ml normal saline) (Total volume-4ml).   : 0.5% bupivacaine 17.5mg (3.5ml) with 5 µg Dexmedetomidine (in 0.5ml normal saline) (Total volume-4ml).The sensory block level will be assessed using loss of sensation to pinprick along the midclavicular line bilaterally and the higher level will be used for statistical purposes if the levels are not the same bilaterally. The motor block will be assessed using modified Bromage scale  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1.Patients who are posted for elective gynecological surgeries.
2.Age group 18-60 years.
3.American Society of Anesthesiologists (ASA) grades I and II.
4.Patients with Body Mass Index (BMI) between 18.5-24.9.

5.Patients with height ranging between 150 cm and 180 cm .

6.Patients who are willing to participate in the study with informed consent.

 
 
ExclusionCriteria 
Details  1.Patients taking alpha-adrenergic receptor antagonists, calcium channel blockers
and angiotensin converting enzyme inhibitors 2.Patients having any absolute contraindications for spinal anaesthesia like
increased intracranial tension, severe hypovolemia, history of bleeding diathesis and
local infection
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the effect and adverse effect of intrathecal Clonidine versus Dexmedetomidine versus 0.9% Saline as adjuvants to 0.5% Hyperbaric Bupivacaine in subarachnoid block in patients undergoing elective gynaecological surgeries by using the following parameters:
1. Duration of analgesia.
2. To assess the onset and duration of motor block.
 		 BASAL , 2 MIN , 5 MIN , 10 MIN , 20 MIN , 30 MIN , 40 MIN , 50 MIN , 60 MIN , 70 MIN , 80 MIN , 90 MIN , 120 MIN , 140 MIN , 160 MIN , 180 MIN  
 
Secondary Outcome  
Outcome  TimePoints 
Peri-operative hemodynamic changes and adverse effects  2 HOURS , 8 HOURS , 12 HOURS , 24 HOURS 
 
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)   22/11/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsharmilasherin@gmail.com].

  6. For how long will this data be available start date provided 16-12-2023 and end date provided 16-12-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Spinal anaesthesia will be performed at the level of L3-L4 through a midline approach using a 25-gauge Quincke spinal needle with patient in lateral position. After confirming free flow of cerebrospinal fluid, drug is injected into subarachnoid space.

Patients will be divided into three groups of thirty each (n=30):-

 Group BC ,Group BD and Group BS.

Group-BC: 0.5% bupivacaine 17.5mg (3.5ml) with 50µg Clonidine (in 0.5ml normal saline) (Total volume-4ml) .     

Group-BD: 0.5% bupivacaine 17.5mg (3.5ml) with 5 µg Dexmedetomidine

(in 0.5ml  normal saline) (Total volume-4ml).

Group-BS:0.5% Bupivacaine 17.5mg (3.5ml) with 0.9% Normal saline (0.5ml)

(Total volume-4 ml).

The time to reach T6 dermatome sensory block will be recorded before surgery.Visual Analog Scale will be recorded up to 24 hours to assess adequacy of analgesia
 
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