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CTRI Number  CTRI/2019/08/020928 [Registered on: 27/08/2019] Trial Registered Prospectively
Last Modified On: 25/08/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to understand the advantages of intrathecal clonidine compared to combination of clonidine with fentanyl in patients undergoing laparoscopic surgeries 
Scientific Title of Study   A comparative study to evaluate the efficacy of intrathecal clonidine versus clonidine with fentanyl in patients undergoing laparoscopic surgeries under conventional general anaesthesia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nazneen Makhbool 
Designation  Post graduate MD Student 
Affiliation  Bangalore Medical College and Research Institute 
Address  Department of Anaesthesiology, Bangalore Medical College and Research Institute,
Fort, Krishna Rajendra Road,
Bangalore
KARNATAKA
560002
India 
Phone  9113654177  
Fax    
Email  singwdluv@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Surekha C 
Designation  Assistant Professor 
Affiliation  Bangalore Medical College and Research Institute 
Address  Department of Anaesthesiology, Bangalore Medical College and Research Institute,
Fort, Krishna Rajendra Road,
Bangalore
KARNATAKA
560002
India 
Phone  9845489724  
Fax    
Email  suri.c13@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Surekha C 
Designation  Assistant Professor 
Affiliation  Bangalore Medical College and Research Institute 
Address  Department of Anaesthesiology, Bangalore Medical College and Research Institute,
Fort, Krishna Rajendra Road,
Bangalore
KARNATAKA
560002
India 
Phone  9845489724  
Fax    
Email  suri.c13@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Road, Bengaluru, Karnataka, Pin- 560002 
 
Primary Sponsor  
Name  Bangalore Medical College and Research Institute 
Address  Department of Anaesthesiology, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Road, Bengaluru, Karnataka, Pin- 560002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Surekha C  Assistant Professor, Department of Anaesthesiology, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Road, Bengaluru, Karnataka, Pin- 560002 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nazneen Makhbool  OT Complex, Victoria Hospital  Operation Theatre Complex, Department of Anaesthesiology, Third Floor, Centenary Building, Victoria Hospital Campus, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Road, Bengaluru, Karnataka, Pin- 560002
Bangalore
KARNATAKA 
9113654177

singwdluv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BMCRI Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K36||Other appendicitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Clonidine  Dose -150 micrograms Frequency - only once via intrathecal route prior to general anaesthesia Duration - duration as short as possible to administer the drug via intrathecal route  
Comparator Agent  Clonidine and fentanyl  Dose -Combination of clonidine 75 micrograms and fentanyl 25 micrograms Frequency - only once, one drug after the other via intrathecal route, prior to general anaesthesia. Duration - duration as short as required to administer the drugs one after the other via the intrathecal route 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1) Patients willing to give informed written consent.
2) ASA physical status I and II patients.
3) Patients of age group 18-55 years, of either sex.
4) Patients undergoing elective laparoscopic surgeries under general anaesthesia lasting less than 2 hours.
5) Patients with Body Mass Index between 18 to 30 kilograms per metre square.
 
 
ExclusionCriteria 
Details  1) Patients with contraindications to spinal technique.
2) Patients with known allergy to clonidine and fentanyl.
3) Patients with cardiovascular and respiratory diseases.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Haemodynamic variables   Intraoperative period - every five minutes till 30 minutes followed by every ten minutes till 60 minutes followed by every fifteen minutes till the end of the surgery  
 
Secondary Outcome  
Outcome  TimePoints 
Haemodynamic response to intubation and extubation  After one minute and five minutes of intubation and after one minute and five minutes of extubation 
Analgesia  The time required for the patient in the post operative ward for the first rescue analgesic when Visual analogue score is greater than 3 
Sedation  Five minutes immediately after extubation in the post operative period 
Incidence of hypotension, hypertension, bradycardia, tachycardia  24 hours in the post operative period  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/09/2019 
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="0"
Months="3"
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)?  

Brief Summary   This is a prospective randomized double blind study comparing the efficacy of intrathecal clonidine 150 micrograms versus intrathecal clonidine 75 micrograms with intrathecal fentanyl 25 micrograms in patients undergoing elective laparoscopic surgeries of duration less than 2 hours under conventional general anaesthesia. iI will be conducted in a total of 60 patients, 30 in each group, in alll the hospitals attached to Bangalore Medical College and Research Institute.The primary outcome is to compare the intraoperative haemodynamic variables along with the haemodynamic response to intubation and extubation. Duration of post operative analgesia and sedation status will also be observed in the post operative period. 
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