| CTRI Number |
CTRI/2022/09/045427 [Registered on: 12/09/2022] Trial Registered Prospectively |
| Last Modified On: |
11/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study for safe anaesthesia in laparoscopic surgeries |
|
Scientific Title of Study
|
Target controlled infusion with propofol in laparoscopic surgeries-a randomised controlled double-blind study of haemodynamic effects with fixed dose intravenous infusion of fentanyl or dexmedetomidine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumith Dhulange |
| Designation |
Junior resident department of Anaesthesiology |
| Affiliation |
Vijaynagar institute of medical sciences |
| Address |
Department of Anaesthesiology,vijaynagar institute of medical sciences
Bellary
KARNATAKA
583104
India |
| Phone |
8217424749 |
| Fax |
|
| Email |
sumithdhulange649@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sumith Dhulange |
| Designation |
Junior resident department of Anaesthesiology |
| Affiliation |
Vijaynagar institute of medical sciences |
| Address |
Department of Anaesthesiology,vijaynagar institute of medical sciences
Bellary
KARNATAKA
583104
India |
| Phone |
8217424749 |
| Fax |
|
| Email |
sumithdhulange649@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bala Bhaskar S |
| Designation |
Professor |
| Affiliation |
Vijaynagar institute of medical sciences |
| Address |
Department of Anaesthesiology,vijaynagar institute of medical sciences
Cantonment
Bellary
KARNATAKA
583104
India |
| Phone |
9880012349 |
| Fax |
|
| Email |
sbalabhaskar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vijaynagar institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Vijaynagar institute of medical sciences |
| Address |
Vijaynagar institute of medical sciences,cantonment, Ballari,pin code-583104 |
| 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 |
| Sumith Dhulange |
Vijaynagar institute of medical sciences |
Department of Anaesthesiology,Surgery OT,OT Complex,Vijaynagar Institute Of Medical Sciences
Bellary
KARNATAKA |
8217424749
sumithdhulange649@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vims ethics committee |
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 |
Fixed dose intravenous infusion of dexmedetomidine |
Inj. Dexmedetomidine is started with bolus dose 1 mcg/kg and followed by infusion (0.5 mcg/kg/hr) before activation of propofol administration by TCI pump |
| Comparator Agent |
Fixed dose intravenous infusion of fentanyl |
Inj. Fentanyl is started with bolus dose 1.5mcg/kg and followed by infusion (0.5 mcg/kg/hr) before activation of propofol administration by TCI pump |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anaesthesiologists physical status 1 to 2
Non obese(BMI 18.5 to 29) |
|
| ExclusionCriteria |
| Details |
Refusal of patient consent
Patients with significant systemic diseases
Patients on long term and concurrent sedative intake |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stability of haemodynamic parameters during laparoscopy (with changes in mean arterial pressure as primary objective) |
1)on arrival to operating room,2)after bolus doses of test drugs,3)pre induction,4)post intubation (1 min, 2min, 5min,10min),5)at initiation of pneumo insufflation, 6)post pneumo- insufflation, 7)every 5 minutes till end of procedure;8)after removal of trocar, 9)stop of propofol infusion , 10)administration of reversal, 11)at extubation, 12)1 min, 2min, 5min and10min following extubation till shift out to Post anesthesia care unit (PACU) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| correlation of TCI propofol with the state entropy levels i.e the effecctor site concentration value of propofol and corresponding state entropy values |
Effector site concentration of propofol and corresponding state entropy values measured
on 1)shifting in ot,2)after bolus doses of test drugs, 3)pre induction, 4)at intubation 5)following intubation at(1 min, 2min, 5min,10min),6) initiation and end of pneumo insufflation, and 7)every 5minutes till end of procedure,8)removal of trocar, 9)stop of propofol infusion, 10)administration of reversal, 11) extubation, 12)1 min, 2min, 5min and10min following extubation
|
| total propofol dose used |
at the end of surgery |
| Postop nausea and vomiting assesment in PACU and postop wards by PONV Impact scale (4 point likert scale) along with vomiting counts |
IN PACU AND postop wards,every 2nd hourly for 24 hours |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
15/09/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomised controlled double blinded study,compares the haemodynamic effects i.e mean arterial pressure as primary outcome in TIVA anaesthetic technique with TCI propofol wherein comparator group fixed dose of intravenous infusion of fentanyl and in intervention group fixed dose intravenous infusion of dexmedetomidine is used in laparoscopic surgries.The secondary outcomes that will be studied are correlation of state entropy values and TCI propofol,total dosage of propofol used and assesment of postop nausea and vomiting. |