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
|
|
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. |