| CTRI Number |
CTRI/2023/10/058228 [Registered on: 04/10/2023] Trial Registered Prospectively |
| Last Modified On: |
21/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare which drug combination is better ketamine- dexmedetomidine versus ketamine-propofol combination in patients undergoing laparoscopic appendectomy under anesthesia |
|
Scientific Title of Study
|
The Effect of intravenous ketamine- dexmedetomidine versus ketamine-propofol in patients undergoing laparoscopic appendicectomy under spinal anaesthesia – A randomized clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRSHANMUGAVALLIE |
| Designation |
Associate proessor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
no.21,A Block,Department of Anaesthesiology, Aarupadai Veedu Medical College and Hospital Kirumampakkam,
PUDUCHERRY
607402
India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
|
| Fax |
|
| Email |
vallijegan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRSHANMUGAVALLIE |
| Designation |
Associate proessor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
no.21,A Block,Department of Anaesthesiology, Aarupadai Veedu Medical College and Hospital Kirumampakkam,
Pondicherry
PONDICHERRY
607402
India |
| Phone |
|
| Fax |
|
| Email |
vallijegan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRSHANMUGAVALLIE |
| Designation |
Associate proessor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
no.21,A Block,Department of Anaesthesiology, Aarupadai Veedu Medical College and Hospital Kirumampakkam,
Pondicherry
PONDICHERRY
607402
India |
| Phone |
|
| Fax |
|
| Email |
vallijegan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai veedu medical college and hospital,Puducherry |
|
|
Primary Sponsor
|
| Name |
Aarupadai veedu medical college and hospital |
| Address |
Aarupadai Veedu Medical College and Hospital,Kirumampakkam,Puducherry |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| self |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR E Shanmugavalli |
Aarupadai veedu medical college |
dept of anaesthesiology,
Aarupadai Veedu Medical College and Hospital,Kirumampakkam
Pondicherry
PONDICHERRY |
9940882722
vallijegan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aarupadai veedu medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
posted for laparoscopic appendicectomy under spinal anaesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intravenous dexmedetomidine |
the effectiveness of intravenous ketamine-dexmedetomidine infusion will be compared with intravenous ketamine-propofol infusion in patients undergoing laparoscopic appendicectomy under spinal anaesthesia .The infusion will be started after arrival of the patient to the operation theatre after connecting the standard ASA monitors and recording the baseline vital parameters |
| Comparator Agent |
intravenous propofol |
the effectiveness of intravenous ketamine-dexmedetomidine infusion will be compared with intravenous ketamine-propofol infusion in patients undergoing laparoscopic appendicectomy under spinal anaesthesia .The infusion will be started after arrival of the patient to the operation theatre after connecting the standard ASA monitors and recording the baseline vital parameters |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
• ASA I and ASA II patients.
• Age between 18 to 60yrs.
• Weight 35-70 kg.
• Gender -both sex.
• Elective laparoscopic appendectomy
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. ASA III and ASA IV
3. Patients with cardiac disease and chronic obstructive airway disease. Patients with a history of allergic reaction to Propofol, ketamine, or dexmedetomidine
• Bleeding diathesis
• Obese patients.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intraoperative Hemodynamic stability |
60 to 120 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sedation score, Time to regain consciousness and complications |
60 to 120 minutes |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 4 |
|
Date of First Enrollment (India)
|
10/10/2023 |
| 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
|
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
- 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 [vallijegan@gmail.com].
- For how long will this data be available start date provided 10-10-2023 and end date provided 10-10-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - -
|
|
Brief Summary
|
A study planned to evaluate the advantage of intravenous drugs ketamine and dexmedetomidine versus ketamine and propofol used for patients undergoing laparoscopic appendicectomy under spinal anaesthesia in terms hemodynamic stability, sedation level ,recovery and complications |