| CTRI Number |
CTRI/2025/08/092411 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare pain by giving opioid and non opioids in patients undergoing cancer surgery |
|
Scientific Title of Study
|
To compare the effects of non-opioid versus opioid anaesthesia for cancer surgeries. An Observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IECKMCMLR-01/2025/03 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ahlam Abdul Rahman |
| Designation |
Senior resident |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical College,
Light house Hill Road,
Mangalore
NIL
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9995681288 |
| Fax |
|
| Email |
ahlam.aar90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ahlam Abdul Rahman |
| Designation |
Senior resident |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical College,
Light house Hill Road,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9995681288 |
| Fax |
|
| Email |
ahlam.aar90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ahlam Abdul Rahman |
| Designation |
Senior resident |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical College,
Light house Hill Road,
Mangalore
NIL
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9995681288 |
| Fax |
|
| Email |
ahlam.aar90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Kasturba Medical College, Light house Hill Road, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
|
|
Primary Sponsor
|
| Name |
Dr Ahlam Abdul |
| Address |
Department of Anaesthesiology Kasturba Medical College Mangalore Light House Hill Road Mangalore 575001 |
| 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 Abdul Rahman |
Kasturba Medical College Mangalore |
Department of Anaesthesiology
KMC hospital Attavar
6th floor OT complex
Dakshina Kannada
KARNATAKA
575001
India
Dakshina Kannada
KARNATAKA |
9995681288
ahlam.aar90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kasturba Medical College Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C801||Malignant (primary) neoplasm, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are of age group 18 to 65 years of both gender
2. Patients who are ASA grade 2 |
|
| ExclusionCriteria |
| Details |
1. Patients with age less than 18 years and more than 65 years
2.patients with significant cardio respiratory disease
3. Patients on Tricyclic antidepressants , anticonvulsants,beta blockers
4. Hypersensitivity to lignocaine,ketamine, dexmedetomidine
5. Pregnancy and lactation
6. Difficult airway
7. Patients with sinus bradycardia and per existing cardiac conduction defects |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of pain management at 12 hours and 24 hours after surgery |
To assess the effectiveness of pain management at 12 hours and 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess incidence of post operative complications like post operative nausea and vomiting at 12 hours and 24 hours after surgery |
To assess incidence of post operative complications like post operative nausea and vomiting at 12 hours and 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
29/08/2025 |
| 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="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 - NO
|
|
Brief Summary
|
It’s an observational study in which we are comparing the effects of non opioid verses opioid anaesthesia on patient outcomes in cancer surgery that is pain and post operative nausea and vomiting. |