| CTRI Number |
CTRI/2019/03/017987 [Registered on: 08/03/2019] Trial Registered Prospectively |
| Last Modified On: |
07/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
study for comparison of dexmedetomidine and clonidine infusion in patients undergoing laparoscopic surgeries |
|
Scientific Title of Study
|
A randomised control study for comparison of dexmedetomidine and clonidine infusion on hemodynamic stability in patients undergoing laparoscopic surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul S S |
| Designation |
Pg resident |
| Affiliation |
shri satya sai medical college |
| Address |
Shri sathya sai medical college and research institute , room no.17 3rd floor , boys hostel
thiruporur-guduvanchery main road , nellikuppam ammapettai
Tamil nadu - 603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
8848714483 |
| Fax |
|
| Email |
rahulsssgmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S N Krishnamoorthy |
| Designation |
Professor and HOD |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Shri Sathya Sai Medical College and Research Institute
Thiruporur Guduvanchery main road
Ammapettai Nellikuppam
Kancheepuram
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9786743120 |
| Fax |
|
| Email |
esenkeyem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul S S |
| Designation |
Pg resident |
| Affiliation |
shri satya sai medical college |
| Address |
Shri sathya sai medical college and research institute , room no.17 3rd floor , boys hostel
thiruporur-guduvanchery main road , nellikuppam ammapettai
Tamil nadu - 603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
8848714483 |
| Fax |
|
| Email |
rahulsssgmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College and Research Institute
Tiruporur Guduvancherry Main Road, Ammapettai,Nellikuppam-603 108, kancheepuram, tamilnadu |
|
|
Primary Sponsor
|
| Name |
Rahul SS |
| Address |
Shri sathya sai medical college and research institute , room no.17 3rd floor , boys hostel
thiruporur-guduvanchery main road , nellikuppam ammapettai
Tamil nadu - 603108 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rahul SS |
Shri satya sai medical college and research institute |
general sugery OT 1
OT complex
second floor
Kancheepuram
TAMIL NADU |
8848714483
rahulsssgmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35-K38||Diseases of appendix, (2) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clonidine |
2mcg/kg/hr infusion started 15 minutes before induction of anaesthesia till the release of pneumoperitoneum |
| Intervention |
Dexmedetomidine |
0.3mcg/kg/hr infusion started 15 minutes before induction of anaesthesia till the release of pneumoperitoneum |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing laparoscopic surgeries |
|
| ExclusionCriteria |
| Details |
patient refusal
ASA III and above
known hepatic and renal dysfunction
known cardiac arrhythmias, congenital heart diseases
pregnant and lactating females |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of hemodynamic parameters during surgery using the two pharmacological agents |
Comparison of hemodynamic parameters during surgery using the two pharmacological agents |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study of postoperative analgesia , incidence of nausea and vomiting and post operative analgesia requirement in two groups |
Study of postoperative analgesia , incidence of nausea and vomiting and post operative analgesia requirement in two groups |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
08/03/2019 |
| 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="1"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Randomised control study for comparison of dexmedetomidine and clonidine infusion on hemodynamic stability in patients undergoing laparoscopic surgeries Aim : To compare hemodynamic stability and efficacy of dexmedetomidine and clonidine in laparoscopic surgeries primary objective : Comparison of hemodynamic parameters during surgery using the two pharmacological agents secondary objective : study of postoperative analgesia, incidence of nausea and vomiting & post operative analgesia requirement in two groups |