| CTRI Number |
CTRI/2018/09/015841 [Registered on: 26/09/2018] Trial Registered Prospectively |
| Last Modified On: |
25/09/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effects of magnesium sulphate and low dose of dexmedetomidine on pulse, BP of patients undergoing laparoscopic cholecystectomy under anaesthesia. |
|
Scientific Title of Study
|
Comparative evaluation of effects of magnesium sulphate and low dose of dexmedetomidine on haemodynamic parameters in patients undergoing laparoscopic cholecystectomy 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 |
Hina Faraz |
| Designation |
Post graduate 2nd year |
| Affiliation |
University college of medical sciences and guru teg bahadur hospital, shahadra, Delhi 95. |
| Address |
Department of anesthesia, critical care and pain medicine, main ICU 2nd floor,guru teg bahadur hospital, shahadra, Delhi 110095
South
DELHI
110095
India |
| Phone |
8826828467 |
| Fax |
|
| Email |
hina.faraz92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hina Faraz |
| Designation |
Post graduate 2nd year |
| Affiliation |
University college of medical sciences and guru teg bahadur hospital, shahadra, Delhi 95. |
| Address |
Department of anesthesia, critical care and pain medicine, main ICU 2nd floor,guru teg bahadur hospital, shahadra, Delhi 110095
Department of anesthesia, critical care and pain medicine, main ICU 2nd floor,guru teg bahadur hospital, shahadra, Delhi 110095
South
DELHI
110095
India |
| Phone |
8826828467 |
| Fax |
|
| Email |
hina.faraz92@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hina Faraz |
| Designation |
Post graduate 2nd year |
| Affiliation |
University college of medical sciences and guru teg bahadur hospital, shahadra, Delhi 95. |
| Address |
Department of anesthesia, critical care and pain medicine, main ICU 2nd floor,guru teg bahadur hospital, shahadra, Delhi 110095
Department of anesthesia, critical care and pain medicine, main ICU 2nd floor,guru teg bahadur hospital, shahadra, Delhi 110095
South
DELHI
110095
India |
| Phone |
8826828467 |
| Fax |
|
| Email |
hina.faraz92@gmail.com |
|
|
Source of Monetary or Material Support
|
| University college of medical sciences and guru teg bahadur hospital, shahadra ,Delhi 110095 |
|
|
Primary Sponsor
|
| Name |
No |
| Address |
No |
| 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 Mahendra kumar |
Guru teg bahadur hospital |
Department of anesthesia, critical care and pain medicine. 2nd floor main ICU,Guru teg bahadur hospital, shahadra,delhi 110095
East
DELHI |
9968399709
mahendramohit@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University college of medical sciences and guru teg bahadur hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z69-Z76||Persons encountering health services in other circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
50mg/kg magnesium sulphate
0.5micrograms/kg dexmedetomidine intravenously in 100 ml NS over 10 min. |
Drug is given over 10min in 100ml NS after induction of anesthesia but before creation of pneumoperitoneum intravenously. |
| Comparator Agent |
50mg/kg magnesium sulphate |
Drug given over 10 min intravenously in 100 ml NS, after induction but before creation of pneumoperitoneum. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for elective laparoscopic cholecystectomy under general anaesthesia.
Aged between 18-60yrs.
Belonging to ASA1. |
|
| ExclusionCriteria |
| Details |
History of cardiovascular diseases like hypertension, ischaemic heart disease,conduction defects etc.
History of compromised renal/hepatic/neuronal functions.
Pregnant/lactating women
Endocrine diseases eg. Diabetes mellitus,hyper and hypothyroidism.
Patient on any drug affecting cardiovascular parameters eg.CCB,beta blockers, magnesium sulphate etc. |
|
|
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 |
| To compare SBP in patients of two groups during pneumoperitoneum |
To compare SBP in patients of two groups during pneumoperitoneum pre induction,just after induction at 1 and 3 min,post induction, during pneumoperitoneum at interval of 10 minutes,after desufflation and after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare HR, DBP and MAP during pneumoperitoneum |
Preinduction,after induction,and post intubation at 1,3 min, before pneumoperitoneum, during pneumoperitoneum at interval of 10 minutes,before desufflation,after desufflation,and after extubation. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/09/2018 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim is to compare effect of magnesium sulphate and low dose of dexmedetomidine on haemodynamic parameters in patients undergoing laparoscopic cholecystectomy under general anaesthesia,under 1%isoflurane and thiopentone as laparoscopic procedures cause various haemodynamic changes therefore we compare both the drugs as to stabilize haemodynamic parameters and which drug is superior over the other. |