| CTRI Number |
CTRI/2024/05/067027 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing 2 different ratios of ketamine and propofol on patient vitals while giving anesthesia in abdominal surgeries |
|
Scientific Title of Study
|
Comparison of ketamine to propofol in 1:2 versus 1:4 ketofol admixture on peri-intubation hemodynamics in exploratory laparotomy:a randomised comparative double blind clinical trial |
| 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 Ruchi Kapoor |
| Designation |
Professor |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Room no 731 A 7th floor OT block , Department of Anaesthesiology, UCMS and GTB Hospital,Dilshad Garden , North east Delhi
Delhi
North East
DELHI
110095
India |
| Phone |
9560678023 |
| Fax |
|
| Email |
rudoc@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Kapoor |
| Designation |
Professor |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Room no 731 A 7th floor OT block , Department of Anaesthesiology, UCMS and GTB Hospital,Dilshad Garden , North east Delhi
Delhi
North East
DELHI
110095
India |
| Phone |
9560678023 |
| Fax |
|
| Email |
rudoc@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suhani Agarwal |
| Designation |
1st year Post Graduate Resident |
| Affiliation |
UCMS and GTB Hospital |
| Address |
ICU 2nd floor Department of Anaesthesiology UCMS and GTB Hospital Dilshad Garden
North East Delhi
Delhi
North East
DELHI
110095
India |
| Phone |
9870682203 |
| Fax |
|
| Email |
suhaniag.2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| UCMS and GTB Hospital
Dilshad garden
New Delhi 110095 |
|
|
Primary Sponsor
|
| Name |
UCMS and GTB Hospital |
| Address |
Department of Anaesthesiology , Dilshad Garden, New Delhi 110095 |
| Type of Sponsor |
Government 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 Ruchi Kapoor |
University College of Medical Sciences and GTB Hospital |
Room no.731A 7th floor OT Block, Department of Anaesthesiology,
UCMS and GTB Hospital
North East Delhi
Delhi
110095
North East
DELHI |
9560678023
rudoc@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Human Research (IEC-HR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A 1:2 Ketofol group |
Group A The admixture prepared will contain 50mg of ketamine and 100mg of propofol diluted up to 20 ml in a single syringe. In the OT, vital monitors will be attached and baseline vitals recorded. Norepinephrine infusion will be kept ready. During 3 minutes of preoxygenation, midazolam 0.04mg/kg slow intravenous injection will be given following which study drug will be given over 30 seconds, dose will be titrated till predefined end point is reached which is loss of verbal response and loss of eyelash reflex. Intubation using RSI will be done. The whole procedure from induction to intubation will be completed within 60 seconds following which general anaesthesia will be followed. Intubating conditions and vitals at scheduled time intervals will be recorded. Norepinephrine, if required, will be started and dose titrated accordingly. Monitoring will be done till 1 hour post intubation. |
| Intervention |
Group B :1:4 Ketofol Group |
Group B admixture will contain 25mg of ketamine and 100mg propofol diluted up to 20 ml in a single syringe
In the OT, vital monitors will be attached and baseline vitals recorded. Norepinephrine infusion will be kept ready. During 3 minutes of preoxygenation, midazolam 0.04mg/kg slow intravenous injection will be given following which study drug will be given over 30 seconds, dose will be titrated till predefined end point is reached which is loss of verbal response and loss of eyelash reflex. Intubation using RSI will be done. The whole procedure from induction to intubation will be completed within 60 seconds following which general anaesthesia will be followed. Intubating conditions and vitals at scheduled time intervals will be recorded. Norepinephrine, if required, will be started and dose titrated accordingly. Monitoring will be done till 1 hour post intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Consenting patients aged 18-65 years posted for expolrative laparotomy under general anaesthesia
2)Hemodynamically stable patients |
|
| ExclusionCriteria |
| Details |
1)Patient with heart block on peri operative ECG
2)Patient with heart rate less than 50bpm
3)Hemodynamically unstable patient with mean arterial pressure less than 60mmHg
4)Patient on inotropes
5)Patient with signs and symptoms of raised intracranial tension
6)Patient with known allergy to any of the drug used |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare incidence of hypotension between groups A and B |
Baseline 0 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) HR, SBP, DBP immediately post induction,
2) HR, SBP, DBP immediately post intubation,
3) Consumption of norepinephrine till 1 hour post intubation,
4) Intubating conditions during intubation
5) HR and MAP at the end of 5 minutes, 10 minutes 15 minutes, 20 minutes, 30 minutes and 1 hour,
|
1)post induction
2)at the time of intubation
3)post intubation
4)5,10,15,20,30,60 minutes post intubation. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
21/05/2024 |
| 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="2"
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
|
Preoperatively , a quick assessment would be made. In the OT, vital monitors will be attached ,iv fluids started and injection glycopyrrolate 0.2mgiv will be given. Baseline blood pressure will be recorded as an average of three consecutive readings with difference <10% in the systolic blood pressure. During preoxygenation, iv. Midazolam 0.04 mg/kg will be given. Study drug will be injected over 30 seconds, dose titrated till predefined end point is reached. The end point would be loss of verbal response and loss of eyelash reflex. Succinylcholine 2 mg/kg will be given and trachea intubated. The whole procedure would be completed in 60 seconds. From the beginning of induction till confirmation of endotracheal tube placement by confirming bilateral air entry, the cricoid pressure would be applied. The intubation conditions will be graded by the same anaesthetist who performed intubation. The assessment would include 1- ease of laryngoscopy (easy: jaw relaxed, no resistance to blade insertion; fair: jaw not fully relaxed, slight resistance to blade insertion; difficult: poor jaw relaxation, active resistance of the patient to laryngoscopy), 2- vocal cord position (easy: abducted; fair: intermediate/moving; difficult: closed), and 3- reaction to insertion of the tracheal tube and cuff inflation (Diaphragmatic movement/coughing) (easy: none; fair: one to two weak contractions or movement for less than 5 seconds; difficult: more than two contractions and/or movement for longer than 5 seconds). The intubation condition will be graded as excellent if all criteria are excellent, good if all criteria are either excellent or good, or poor if any criterion is graded as poor. If after 3 attempts, intubation is unsuccessful, Proseal LMA will be inserted and case excluded from study. An episode of hypotension (decrease in MAP > 20 % from baseline) will be immediately managed by norepinephrine starting with 5µg/min infusion (Norepinephrine 80µg/ml) and titrated to MAP. At the end of 1 hour of intubation, the amount of norepinephrine consumed in either group will be noted and, if further required, continued while titrating with MAP. |