FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close