| CTRI Number |
CTRI/2023/05/052837 [Registered on: 18/05/2023] Trial Registered Prospectively |
| Last Modified On: |
16/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Haemodynamic response to intubation |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF HAEMODYNAMIC RESPONSE TO INTUBATION WITH PROPOFOL,KETAMINE AND KETOFOL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M REETHM |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology and intensive care , NIMS , punjagutta, Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9398188515 |
| Fax |
|
| Email |
REETHAMMUDDAMALLA@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
NIRMALA J |
| Designation |
Professor of anaesthesiology |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
NIZAMS INSTITUTE OF MEDICAL SCIENCES
Hyderabad
TELANGANA
500082
India |
| Phone |
9849422749 |
| Fax |
|
| Email |
Njonnavithula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M REETHM |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology and intensive care, NIMS ,punjagutta, Hyderabad
6-204,SRINI DEVELOPERS,GANGASTHAN PHASE 2,NIZAMABAD
Hyderabad
TELANGANA
500082
India |
| Phone |
9398188515 |
| Fax |
|
| Email |
REETHAMMUDDAMALLA@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Nizams institute of medical sciences , punjagutta, Hyderabad 500082 |
|
|
Primary Sponsor
|
| Name |
M REETHM |
| Address |
Doctors club,nizams institute of medical sciences |
| Type of Sponsor |
Research institution and hospital |
|
|
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 REETHM |
NIMS HOSPITAL |
3rd floor , OT complex , super speciality block , Nims hospital
Hyderabad
TELANGANA |
9398188515
Reethammuddamalla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS INSTITUTIONAL 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 |
| Comparator Agent |
Propofol , ketamine and ketofol |
Patients are randomised into three groups. Propofol 1.5-2.5mg/kg I.V. , ketamine 1-2mg/kg I.V , ketofol mixed in 2:1 proportion of propofol and ketamine according to the body weight given respectively to the randomised groups as an induction agents |
| Intervention |
Sevoflurane, I.v. Mephentermine, I.v. Atropine and I.v. Esmolol |
Hypertensive episodes are treated by adjusting dial concentration of inhalational agent sevoflurane. Hypotensive episodes are managed by using I.v. Mephentermine 6mg. To treat tachycardia (100bpm) injection as esmolol 0.5 MG per KG will be given and for Brady cardia injection atropine 0.06MG per KG. will be given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing elective surgery under general anesthesia and with valid consent
2.ASA grade 1 and 2 patients |
|
| ExclusionCriteria |
| Details |
1.Emergency surgeries
2.Prior sensitization or allergic reaction to propofol, ketamine, soy or egg products
hemodynamic instability
3.Head injury
4.Increased intracranial or intraocular pressure
5.Pregnancy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic stability in terms of systolic blood pressure, diastolic blood pressure and mean arterial pressure are maintained when patient is induced with ketofol (combination of propofol and ketamine ) rather than when used alone as an induction agents |
Baseline , 1 minute ,3minutes , 5 minutes ,15 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in post operative nausea and vomiting and decreased incidence of hallucinations |
Immediately after extubation, 15 minutes , 30 minutes and 1 hour after extubation |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/09/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laryngoscopy and tracheal intubation are commonly used for airway management during general anesthesia.Propofol and ketamine are commonly used as an induction agents. Propofol has cardiovascular and respiratory depressant side effects whereas ketamine stimulates the cardiovascular system elevating heart rate, blood pressure and cardiac output.We hypothesise that combination of propofol-ketamine provides better Haemodynamic stability when compared to propofol and ketamine alone because of its distinct pharmacodynamic properties |