| CTRI Number |
CTRI/2022/01/039446 [Registered on: 14/01/2022] Trial Registered Prospectively |
| Last Modified On: |
14/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TWO DRUGS FOR POST OP ANALGESIA |
|
Scientific Title of Study
|
Comparison of Intravenous Tramadol vs Nalbuphine as analgesic in postoperative patients after General Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SANDIP BAHETI |
| Designation |
PROFESSOR |
| Affiliation |
dr. d. y patil vidyapeeth |
| Address |
Department of anaesthesiology dr. d. y. patil vidyapeeth, pimpri, pune
dr. d. y. patil vidyapeeth, pimpri, pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9676989293 |
| Fax |
|
| Email |
snbacademics12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
sonalika tudimilla |
| Designation |
junior resident |
| Affiliation |
dr. d.. y. patil vidyapeeth |
| Address |
Department of anaesthesiology dr. d. y. patil vidyapeeth, pimpri, pune
dr. d. y. patil vidyapeeth, pimpri, pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9676989293 |
| Fax |
|
| Email |
sona3668@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chaitanya Gaidhani |
| Designation |
senior resident resident |
| Affiliation |
dr. d.. y. patil vidyapeeth |
| Address |
Department of anaesthesiology dr. d. y. patil vidyapeeth, pimpri, pune
dr. d. y. patil vidyapeeth, pimpri, pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9676989293 |
| Fax |
|
| Email |
chatsrulz@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
dr d y patil vidyapeeth pimpri pune |
| Address |
dr. d. y. patil vidyapeeth, pimpri, pune |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| dr d y patil vidyapeeth pimpri pune |
dr. d. y. patil vidyapeeth, pimpri, pune |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonalika Tudimilla |
dr. d. y. patil vidyapeeth, pimpri, pune |
Department of anaesthesiology dr. d. y. patil vidyapeeth, pimpri, pune
Pune
MAHARASHTRA |
9676989293
sona3668@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics sub-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 |
Nalbuphine |
0.05 mg/kg intravenous at 0, 2, 5, 15, 30 ,minutes |
| Comparator Agent |
Tramadol |
1mg/kg intravenous at 0, 2, 5, 15, 30 ,minutes |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patient between 18 years to 60 years of either sex
2. American Society of Anaesthesiologists (ASA) grade I &II undergoing elective surgeries under general anaesthesia
• Weight of patient within normal range for that age andsex
• Patients who are willing for the study and have given written informed consent |
|
| ExclusionCriteria |
| Details |
1.Patients with pre-existing cardiovascular diseases (IHD, hypertension, Valvular Heart diseases, deranged renal or liver functions.
2.Patients with physical dependence to opioids.
• Pregnant and lactating females.
• Patients with diabetes, asthma, epilepsy, bleeding disorder.
• Patients on monoamine oxidase, tricyclic antidepressants, selective serotonin reuptake inhibitors, andwarfarin
• History of hypersensitivity to study drugs
• Patients not willing to participate in the study will be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| for analgesia |
0, 2, 5, 15, 30 ,minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| for analgesiA |
for 30 mins to 2 hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/01/2022 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
comparison of two drugs that is Tramadol and Nalbuphine for postoperative analgesia in patients undergoing procedures under general anesthesia. Will publish soon |