| CTRI Number |
CTRI/2021/11/038123 [Registered on: 18/11/2021] Trial Registered Prospectively |
| Last Modified On: |
18/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the effects of two drugs, Dexmedetomidine and Magnesium Sulphate, on the Blood Pressure and Pukse rate changes that occur during Laparoscopic surgeries |
|
Scientific Title of Study
|
Comparative study of hemodynamic changes with dexmedetomidine versus magnesium sulphate as adjuncts during anaesthesia in laparoscopic surgeries – a double blinded randomised study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr BI Nirupama |
| Designation |
MD Anesthesiology |
| Affiliation |
Chettinad Hospital and Research Institute, Kelambakkam |
| Address |
D block 1st floor Department of Anaesthesiology
Chettinad Hospital and Research Institute
Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
|
| Fax |
|
| Email |
b.i.nirupama@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Anand S |
| Designation |
Professor Anesthesiology |
| Affiliation |
Chettinad Hospital and Research Institute Kelambakkam |
| Address |
D block 1st floor Department of Anaesthesiology
Chettinad Hospital and Research Institute
Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
|
| Fax |
|
| Email |
dranandmurugan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Anand S |
| Designation |
Professor Anesthesiology |
| Affiliation |
Department of Anaesthesiology Chettinad Hospital and Research Institute Kelambakkam |
| Address |
D block 1st floor Department of Anaesthesiology
Chettinad Hospital and Research Institute
Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
|
| Fax |
|
| Email |
dranandmurugan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital and Research Institute |
|
|
Primary Sponsor
|
| Name |
Chettinad Hospital And Research Institute |
| Address |
D block 1st floor Department of Anaesthesiology
Chettinad Hospital and Research Institute
Kelambakkam |
| Type of Sponsor |
Private 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 BI Nirupama |
Chettinad Hospital and Research Institute |
D block 1st floor department of anesthesiology chettinad hospital and research institute
Kancheepuram
TAMIL NADU |
9566083030
b.i.nirupama@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research CARE IHEC-I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IV Dexmedetomidine
|
IV Dexmedetomidine 1 mcg/kg in 100 mL normal saline over 15 mins
|
| Intervention |
IV MAGNESSIUM SULPHATE |
IV Magnessium Suphate 50mg/kg in 100 mL over 15 min |
| Comparator Agent |
Nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
asa grade 1 and 2 elective and emergency laparoscopic surgeries |
|
| ExclusionCriteria |
| Details |
morbid obesity pregnant woman renal or hepatic dysfunction cardiovascular insufficiency |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| hemodynamic response of two drugs during intubation and CO2 insuffulation |
At baseline.
Intubation response : Immediately after intubation(T0)
1 mintue after intubation (T1)
3 mintues after intubation (T3)
5 minutes after intubation (T5)
Before insuffulation
1 minute after CO2 insuffulation (C1)
3 minutes after CO2 insuffulation (C3)
5 minutes after CO2 insuffulation (C5)
Every 10 minute intraoperative monitoring |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hemodynamic response of two drugs during extubation and postoperative sedation score of patient |
5 minutes post extubation |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
21/11/2021 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [b.i.nirupama@gmail.com].
- For how long will this data be available start date provided 21-11-2022 and end date provided 21-03-2033?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
•
All patients undergoing laparoscopic surgeries will undergo
pre-anaesthetic assessment and informed and written consent will be taken.
•
The drugs to be given - group D: dexmedetomidine loading 1 mcg/kg in 100
mL normal saline over 15 min; and Group M: magnesium sulfate 50mg/kg in 100 mL
over 15 min, prior to intubation.
•
Baseline data systolic blood pressure (SBP), diastolic blood pressure
(DBP), mean arterial blood pressure (MAP), and heart rate (HR) were
noninvasively monitored
•
SBP,
DBP, MAP and HR to be monitored at every 10 min intervals throughout the
surgery. Following extubation, patients
were maintained on supplemental O2 and transferred to recovery room.
•
Intubation
response : immediately after intubation (T0), 1 min after intubation (T1),
3mins after inubation (T3), 5mins after intubation (T5)
•
CO2 insufflation :1mins after insufflation (C1), 3mins after
insufflation(C3), 5mins after insufflation (C5)
•
Extubation response : immediately after extubation (E0), 1min after
extubation (E1), 5mins after extubation (E5)
•
The degree of sedation was assessed at the end of surgery after the
patient is received in the recovery room using Brussels sedation scale |