| CTRI Number |
CTRI/2023/11/059596 [Registered on: 07/11/2023] Trial Registered Prospectively |
| Last Modified On: |
06/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing preoperative and intraoperative ketamine infusion for pain management in lap appendicectomy |
|
Scientific Title of Study
|
Comparision of preoperative ketamine infusion with intraoperative ketamine infusion for postoperative pain management in laparoscopic appendicectomy |
| 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 Hemaa S |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Shri sathya sai medical college and research institute,
Ammapettai,
Chengalpattu taluk,
Kancheepuram district,
nellikuppam p.o
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
8610242653 |
| Fax |
|
| Email |
shemaa2796@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Narayanan S |
| Designation |
Professor |
| Affiliation |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Shri sathya sai medical college and research institute,
Ammapettai,
Chengalpattu taluk,
Kancheepuram district,
nellikuppam p.o
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9444877188 |
| Fax |
|
| Email |
dr.vijay@live.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemaa S |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Shri sathya sai medical college and research institute,
Ammapettai,
Chengalpattu taluk,
Kancheepuram district,
nellikuppam p.o
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
8610242653 |
| Fax |
|
| Email |
shemaa2790@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri sathya sai medical college and research institute, ammapettai,nellikuppam,Kancheepuram-603108 |
|
|
Primary Sponsor
|
| Name |
Dr Hemaa S |
| Address |
Shri sathya sai medical college and research institute,
Ammapettai,
Chengalpattu taluk,
Kancheepuram district,
nellikuppam p.o |
| Type of Sponsor |
Other [Self] |
|
|
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 Hemaa S |
Shri sathya sai medical college and research institute |
Ot complex,Shri sathya sai medical college and research
Chengalpattu taluk,
Kancheepuram district,
nellikuppam p.o
Kancheepuram
TAMIL NADU |
8610242653
shemaa2796@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri sathya sai medical college and research institute,INSTITUTE HUMAN 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 |
Intraoperative ketamine infusion |
Intraoperative ketamine infusion of 0.15mg/kg iv is given after wound closure |
| Comparator Agent |
Pre Operative ketamine infusion |
Preinduction group patients received ketamine infusion 0.15mg/kg iv immediately before the induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Age group 18-60 years.
2)Patient fit under ASA 1 and 2. |
|
| ExclusionCriteria |
| Details |
1)Age>60 years.
2)ASA 3 and 4.
3)Patients who are contraindicated for General Anaesthesia
4)BMI>30 |
|
|
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 |
| To compare the severity of postoperative pain,time for breakthrough pain,dose of postoperative analgesia needed |
5th min, 10th min, 15th min, 20th min, 25thmin, 30thmin, 1st hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To compare the intraoperative hemodynamic changes.
• Incidence of nausea ,vomiting.
• To compare the postoperative sedation |
Intraoperative parameters like BP, PR and spo2 will be recorded every 5minutes for the first 20 minutes then every 10 minutes till the
end of the surgery. Pain score will be monitored by VAS score |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 1 |
|
Date of First Enrollment (India)
|
14/11/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Postoperative pain management impacts the well being and rehabilitation of the patient. • Tissue injury during surgery modifies the central processing pathway for pain perception. • Preventing sensitization by an analgesic administered before a painful stimuli is the basis for preemptive analgesia. • The induction and maintainance of central sensitization depends on tha activation of N-methyl-D aspartic acid receptors(NMDA). • Administration of ketamine ,an NMDA receptor antagonist prevents central sensitization to peripheral nociceptor stimulus and prevents postoperative pain. • This study aimed to compare the postoperative analgesic requirement in patients receiving ketamine before skin incision with those receiving after wound closure. |