| CTRI Number |
CTRI/2025/03/082618 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
09/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing the effects of Dexmedetomidine medicine versus Remifentanil medicine on Blood pressure ,heart rate and Wake up time in Elderly Patients admitted for Robotic surgeries
|
|
Scientific Title of Study
|
A Prospective Randomised Controlled Study Comparing the effects of Dexmedetomidine versus Remifentanil Infusion on Perioperative Hemodynamics and Recovery Profiles in Elderly Patients undergoing Robotic surgeries
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruby J Babu |
| Designation |
Registrar |
| Affiliation |
Fortis Hospital |
| Address |
Babu Mandiram,
Hospital Road,
Vakkom P.O.
Trivandrum :695308
Kerala
Mulund-Goregaon Link Road,
Nahur West, Industrial Area, Bhandup West,
Mumbai,
Maharashtra 400078
Thiruvananthapuram
KERALA
695308
India |
| Phone |
09496468826 |
| Fax |
912241114111 |
| Email |
ruby.jbabu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ruby J Babu |
| Designation |
Registrar |
| Affiliation |
Fortis Hospital |
| Address |
Babu Mandiram,
Hospital Road,
Vakkom P.O.
Trivandrum :695308
Kerala
Mulund-Goregaon Link Road,
Nahur West, Industrial Area, Bhandup West,
Mumbai,
Maharashtra 400078
Hingoli
KERALA
695308
India |
| Phone |
09496468826 |
| Fax |
912241114111 |
| Email |
ruby.jbabu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruby J Babu |
| Designation |
Registrar |
| Affiliation |
Fortis Hospital |
| Address |
Babu Mandiram,
Hospital Road,
Vakkom P.O.
Trivandrum :695308
Kerala
Mulund-Goregaon Link Road,
Nahur West, Industrial Area, Bhandup West,
Mumbai,
Maharashtra 400078
Hingoli
KERALA
695308
India |
| Phone |
09496468826 |
| Fax |
912241114111 |
| Email |
ruby.jbabu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Fortis Hospital |
| Address |
Mulund-Goregaon Link Road, Nahur West, Industrial Area, Bhandup West, Mumbai, Maharashtra 400078 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Grenada |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrRuby JBabu |
Fortis Hospital |
Dr.Vijay Shetty,
HOD,
Department of anaesthesia,
Second Floor OT Complex,
Fortis Hospital,
Mulund,Mumbai
Mumbai
MAHARASHTRA |
9496468826
ruby.jbabu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Academic Ethics Committee ,Fortis Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N25-N29||Other disorders of kidney and ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine Infusion |
To study perioperative hemodynamics and wake up profiles |
| Intervention |
Remifentanil Target Controlled Infusion |
To study perioperative hemodynamics and wake up profiles |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Aged more than 60years
2) ASA I and 2 listed for robotic surgeries with duration more than 3hours
|
|
| ExclusionCriteria |
| Details |
1) Aged less than 59 years.
2) Refusal by patient.
3) Patients with severe respiratory disease or ischemic cardiac findings on ECG or cardiac conductive defects belonging to ASA 3 or 4
4) Obese patient with BMI greater than 35
4) Patients on beta blockers with a basal heart rate less than 55beats per minute |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)The recovery time in both the groups (response to verbal commands, extubation time and orientation time)
2)The perioperative hemodynamics in both groups |
1)Recovery Profiles-Immediately after the surgery
2)Baseline ,Induction time,Every half an hourly during the surgery till the surgery gets over the heart rate and blood pressure will be monitored |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Comparing the post operative cognition in both groups
2)Comparing post operative nausea, vomiting, sedation scores & pain scores in 2 groups
3)To assess & compare intraoperative complications like bradycardia & hypotension |
1) Immediate post operative period
2)Immediate post operative period in recovery room till patient is shifted to ward
3)During the surgery the heart rate & blood pressure will monitored |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
30/03/2025 |
| 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 - 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 - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ruby.jbabu@gmail.com].
- For how long will this data be available start date provided 04-04-2025 and end date provided 04-11-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In
our study, we are comparing the effects of intraoperative infusion of dexmedetomidine
and remifentanil on perioperative hemodynamics and recovery profiles in elderly
patients undergoing robotic surgeries. Existing literature have tried to
compare and assess various parameters like intraoperative blood loss,
hemodynamics, post- operative pain scores and other side effects like PONV,
shivering and sedation scores. Most of the studies have been in conducted in, a
wide range of patient age profiles and in short duration surgeries .There are
limited studies comparing the recovery profiles of elderly patients undergoing
major robotic surgeries which is associated with prolonged surgical duration
,pneumoperitoneum and extreme patient positioning . Hence, in this study we
describe our adaption of comparing dexmedetomidine versus remifentanil as a
part of enhanced recovery in elderly patients undergoing robotic surgeries.
|