| CTRI Number |
CTRI/2024/11/076349 [Registered on: 07/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Analysis of Ketamine-Propofol Ratios for Reducing Intraoperative Hypotension in Emergency Laparotomy: A Clinical Study |
|
Scientific Title of Study
|
Comparison of 1:1 and 1:3 ratios of ketamine-propofol admixture in rapid-sequence induction of anesthesia for emergency laparotomy: A randomized comparative study |
| 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 M Pradeep |
| Designation |
PG Resident |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Dept of Anaesthesiology, MS Ramaiah Medical College, MSRIT Post, Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
9535390581 |
| Fax |
|
| Email |
pradeepmoorthy98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr M Pradeep |
| Designation |
PG Resident |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Dept of Anaesthesiology, MS Ramaiah Medical College, MSRIT Post, Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
9535390581 |
| Fax |
|
| Email |
pradeepmoorthy98@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Yatish B |
| Designation |
Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Dept of Anaesthesiology, MS Ramaiah Medical College, MSRIT Post, Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
9886197658 |
| Fax |
|
| Email |
yatishseeni@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| MS Ramaiah Medical College,
M.S.Ramaiah Nagar,
MSRIT Post,
Bangalore - 560054 |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah Medical College |
| Address |
New BEL Road,
M.S.Ramaiah nagar,
MSRIT Post,
Bangalore - 560054 |
| Type of Sponsor |
Private medical college |
|
|
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 Yatish B |
MS Ramaiah Medical College and Hospital |
Dept of Anaesthesiology, 2nd floor, MS Ramaiah Medical College, New BEL Road, Bangalore, 560054 Bangalore KARNATAKA |
9886197658
yatishseeni@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1:1 ratio of Ketamine-Propofol Admixture |
Effect of 1:1 ratio of Ketamine-Propofol Admixture on Blood pressure for 20 minutes post induction of anaesthesia. |
| Comparator Agent |
1:3 Ratio of Ketamine-Propofol Admixture |
Effect of 1:3 Ratio of Ketamine-Propofol Admixture on blood pressure for 20 minutes post induction of anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with American Society of Anaesthesiologists (ASA) Grading I E to III E.
2.Patients scheduled for emergency laparotomy under General Anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Patients with a history of difficult intubation, abnormal airway examination, cardiac morbidities.
2. Patients on angiotensin converting enzyme inhibitors and angiotensin receptor blockers medications
3. Patients with uncontrolled hypertension.
4. Patients with existing hypotension on inotrope support.
5. Patients with allergy of any of the study drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison between 1:1 and 1:3 ratios of ketamine-propofol admixture with requirement of norepinephrine. |
First 20 minutes after induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the incidence and severity of post induction hypotension. |
First 20 minutes after induction of anaesthesia |
| To assess and compare the intubation conditions using intubation scoring. |
First 20 minutes after induction of anaesthesia |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="10" 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
|
Post-induction
hypotension (i.e. arterial hypotension occurring during the first 20 min after
anaesthesia induction) and early intraoperative hypotension ( i.e. arterial
hypotension during the first 30 min of surgery) can lead to serious organ
failure and death. [1] Post-induction hypotension is closely related
to the anaesthetic drugs, hence manipulation of induction agents prevents post-induction
hypotension.
Patients who are in need of emergency
laparotomy require a balance between adequate hypnosis and maintenance of
stable hemodynamics because they are in a hemodynamically compromised state. [2]
For intubation in emergency and full stomach patients, rapid sequence induction
(RSI) plays an important role in avoiding the risk of aspiration of gastric
contents.
Propofol is the most common hypnotic used but
it is associated with hypotension whereas ketamine, even though not routinely
used, produces dissociative anaesthesia and sympathetic stimulation thus providing
a more stable hemodynamic profile. [3] Therefore combination of
ketamine and propofol may potentially balance each other’s hemodynamic adverse
effects and, therefore, offer a safer alternative of induction prior to endotracheal
intubation. [4] The positive effects of each drug may indeed balance
the other product downsides: sympathomimetic effects of ketamine could mitigate
propofol-associated hypotension and respiratory depression, and propofol could
limit the psychiatric side effects of ketamine.
We hypothesise that compared to propofol, ketamine +
propofol (KETOFOL) may have a better safety profile.[2]
Ketamine/Propofol mixture (KETOFOL) has less respiratory adverse effects than
propofol alone in Emergency procedural sedation.[5] Currently there
is paucity of literature detailing the efficacy of different admixtures of
ketofol in Indian population and hence this study is designed to evaluate its
role in reducing norepinephrine requirements and reducing incidence of
post-induction hypotension. |