| CTRI Number |
CTRI/2024/03/064505 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| 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
|
Study on dose requirement of dexmedetomidine with the use of Bispectral Index Monitoring |
|
Scientific Title of Study
|
Impact of bispectral index monitoring on dose requirement of dexmedetomidine during total parotidectomy under general anesthesia without use of muscle relaxants. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil Rajan |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences, Kochi |
| Address |
Department of Anaesthesiology,
Amrita Institute of Medical Sciences, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
04842856162 |
| Fax |
04842802020 |
| Email |
suneil71@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Kumar |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences, Kochi |
| Address |
Department of Anaesthesiology,
Amrita Institute of Medical Sciences, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
04842856162 |
| Fax |
04842802020 |
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maharnab Bhuyan |
| Designation |
MD Resident |
| Affiliation |
Amrita Institute of Medical Sciences, Kochi |
| Address |
Department of Anaesthesiology, Amrita Institute of Medical Sciences , Kochi
Ernakulam
KERALA
682041
India |
| Phone |
04842856162 |
| Fax |
04842802020 |
| Email |
bubhuyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Science, Kochi |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences |
| Address |
AIMS, Ponnekkara P.O, Kochi 682041, Kerala |
| 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 Sunil Rajan |
Amrita Institute of Medical Sciences |
Department of Anaesthesiology
Ernakulam
KERALA |
04842856162
04842802020
suneil71@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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 |
Bispectral Index Monitoring |
In one group of patients the dose of dexemedetomidine will be adjusted with bispectral index monitoring throughout period of surgery |
| Comparator Agent |
No Bispectral Index Monitoring |
In one group of patients the dose of dexmedetomidine will not be adjusted with bispectral index monitoring. A predefined dose will be given throughout the period of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
-American Society of Anesthesiologists physical status (ASA PS) 2 to 3,
-Patients undergoing total parotidectomy with nerve conduction studies
|
|
| ExclusionCriteria |
| Details |
-Patients with basal HR less than sixty per min,
-beta blockers,
-heart blocks,
-hypersensitivity to dexmedetomidine
-nasal intubation or fibreoptic intubation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the intraoperative dexmedetomidine infusion dose requirement with and without bispectral index (BIS) monitoring in patients undergoing total parotidectomy under general anesthesia without use of muscle relaxants. |
End of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare intraoperative patient immobility, hemodynamic responses, sevoflurane & propofol consumption, need for intervention if patient moves, incidence of hypotension, use of vasopressors & time taken for extubation in both groups. |
patient immobility will be assessed at end of surgery, hemodynamic responses will be assessed every half hourly during surgery, sevoflurane & propofol consumption will be noted at the end of surgery, & the time taken for extubation will be documented at the end of surgery. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/03/2024 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a Randomised prospective single blinded study, in which we assess the effect of Bispectral Index Monitoring (BIS) in the amount of dexmedetomidine infusion dose required in a case of Parotidectomy surgery without the use of muscle relaxants. In this study we recruit two groups; in one group we use BIS to titrate the infusion dose of Dexmedetomidine intraoperatively; while in the other group we use standard prescribed infusion dose of dexmedetomidine i.e. 0.5mcg/kg/hr and then titrate it according to Hemodynamic Parameters and Patient movements. At the end of the study the collected data will be analysed statistically. |