| CTRI Number |
CTRI/2019/04/018356 [Registered on: 01/04/2019] Trial Registered Prospectively |
| Last Modified On: |
29/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of two medicines on blood pressure while the patients undergo a procedure of surgery by laparascopy under full anaesthesia. |
|
Scientific Title of Study
|
A comparative study of infusion dexmedetomidine and infusion magnesium sulphate on attenuation of hemodynamic changes in laparoscopic surgery under 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 |
Gyanendra Kumar |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical Care Medicine, IGIMS, Patna
Sheikhpura, Bailey Road, Patna 14
Patna
BIHAR
800014
India |
| Phone |
7762808904 |
| Fax |
|
| Email |
gyanendrakumar739@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof K H Raghwendra |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical Care Medicine, IGIMS, Patna
Sheikhpura, Bailey Road, Patna 14
Patna
BIHAR
800014
India |
| Phone |
9835092798 |
| Fax |
|
| Email |
dr.khraghwendra@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prof K H Raghwendra |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical Care Medicine, IGIMS, Patna
Sheikhpura, Bailey Road, Patna 14
Patna
BIHAR
800014
India |
| Phone |
9835092798 |
| Fax |
|
| Email |
dr.khraghwendra@ymail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna 800014 |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of Medical Sciences |
| Address |
Sheikhpura, Patna 800014
Bihar |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Gyanendra Kumar |
Indira Gandhi Institute of Medical Sciences |
!st floor, Ward Block, Department of Anaesthesiology, IGIMS, Sheikhpura, Patna 14
Patna
BIHAR |
7762808904
gyanendrakumar739@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmeditomidine vs Magnesium Sulfate |
Dexmeditomidine loading dose 1mcg/kg in 20ml normal saline over 15 minutes intravenously. Infusion rate 0.4 mcg/kg/hr intravenously.
Magnesium sulfate loading dose 2g in 20 ml normal saline over 15 minutes intravenously. Infusion rate 15mcg/kg/min intravenously. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA physical status 1 and 2
Patients undergoing laparoscopic surgery
Patient willing to participate |
|
| ExclusionCriteria |
| Details |
Patients refusal to participate
Patients with pregnancy
Morbid Obesity
Full stomach and emergency surgery
Patients with suspected difficult laparoscopic surgery
Patients sensitive to drug
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study of drug dexmedetomidine and infusion of magnesium sulphate on hemodynamic responses. |
From administration of drug to upto 6 hours in post anaesthesia care unit. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the relative efficacy of infusion of dexmedetomidine and infusion of magnesium sulphate on hemodynamic responses in laparoscopic surgery under general anaesthesia. |
From administration of drug to upto 6 hours in post anaesthesia care unit. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/04/2019 |
| 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="2"
Months="0"
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
|
A comparative study of infusion dexmedetomidine and infusion magnesium sulphate on attenuation of hemodynamic changes in laparoscopic surgery under general anaesthesia. |