| CTRI Number |
CTRI/2018/01/011595 [Registered on: 30/01/2018] Trial Registered Prospectively |
| Last Modified On: |
16/07/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of propofol and ketofol for anesthesia by intravenous route. |
|
Scientific Title of Study
|
Clinical comparison of Propofol with Propofol- Ketamine combination (Ketofol) for Total Intravenous Anesthesia (TIVA)in short surgical procedures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Namrata Shah |
| Designation |
Assistant Professor |
| Affiliation |
Department Of Anesthesia, B.J. Medical College, Ahmedabad |
| Address |
F-3, Department of Anesthesia,
B.J.Medical college And Civil hospital ,Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825521519 |
| Fax |
|
| Email |
drnamrata99@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Shah |
| Designation |
Assistant Professor |
| Affiliation |
Department Of Anesthesia, B.J. Medical College, Ahmedabad |
| Address |
F-3, Department of Anesthesia,
B.J. Medical College And civil hospital, Asarwa,
Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825521519 |
| Fax |
|
| Email |
drnamrata99@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namrata Shah |
| Designation |
Assistant Professor |
| Affiliation |
Department Of Anesthesia, B.J. Medical College, Ahmedabad |
| Address |
F-3, Department of Anesthesia,
B.J.Medical college and civil hospital, Asarwa
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825521519 |
| Fax |
|
| Email |
drnamrata99@yahoo.com |
|
|
Source of Monetary or Material Support
|
| BJMedical College,
New Civil Hospital, Haripura, Ahmedabad, Gujarat 380016 |
|
|
Primary Sponsor
|
| Name |
BJMedical College Ahmedabad |
| Address |
New Civil Hospital, Haripura, Asarwa, Ahmedabad, Gujarat
380016 |
| 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 Namrata Shah |
B.J.Medical College & Civil Hospital, Asarwa, Ahmedabad |
F-3,Main operation theater,Civil Hospital, Asarwa
Ahmadabad
GUJARAT |
9825521519
drnamrata99@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee,B.J.Medical College & Civil Hospital Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA Physical Status I &II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ketofol compared with propofol |
dose of propofol is 2.5mg/kg and in ketofol , the dose of ketamine is 1 mg/kg and propogol is 2 mg/kg. injected drug will be prepared in 10 ml of syringe. Incremental dose of drugs will be administered when there is tachypnoea, movement or phonation.Total duration of therapy will be one hour or less then one hour. |
| Intervention |
ketofol is compared with propofol |
oxygen is administerd via ventimask throughout the surgery. when there is apnea, respiratory depression or hypoventilation, 100% oxygen will be administered via bains circuit. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status I&II |
|
| ExclusionCriteria |
| Details |
ASA Physical Status III, IV, V
Hypersensitivity reaction to study drug, soyabean oil, glycerol, egg lrcithin
Pregnant and lactating patients
Patients with history of neurologic and psychiatric disease
difficult airway |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
hemodynamic parameters
pain on injection
mood status
cognitive function postoperative recovery complications likr apnea, respiratory depression, desaturation, hypotension, hypertension, bradycardia, tachycardia, nausea, vomiting |
hemodynamic parameters
pain on injection
mood status
cognitive function postoperative recovery complications likr apnea, respiratory depression, desaturation, hypotension, hypertension, bradycardia, tachycardia, nausea, vomiting |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
hemodynamic parameters
mood status
cognitive function
complications like apnea, respiratiry depression,hypotension,hypertension,bradycardia, tachycardia,nausea,vomiting |
postoperatively every 5 minutes till patient is fully concious |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
01/02/2018 |
| 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="4"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Total intravenous Anesthesia is a technique in which combination of drugs are used for anesthesia via intravenous route only. Propofol is most commonly used agent till now as it provides rapid induction and faster recovery. Dose dependent cardiorespiratory depression and lack of analgesia are the main disadvantages. Ketamine provides excellent analgesia and has little or no cardiorespiratory depression. Emergence reactions is the main side effect of Ketamine. Ketofol is a combination of ketamine and propofol which is physically compatible and chemically stable. It has favorable hemodynamics, improved spontaneous ventilation andfaster recovery of postoperative cognitive function. The objective of this study is to evaluate and compare ketofol as a suitable induction agent alternative to propofol as a total intravenous anesthetic agent, hemodynamic stability, recovery of postoperative cognitive function of the patient and side effects.
Till
today 37 patients in ketofol group (group KP) and 31 patients in propofol
(group P) group has been evaluated.
Result
Demographic
data
Gender -
ketofol group = 14 male and 17 female patients
propofol group = 22 male and 15
female patients
Average
age
- ketofol group 30yrs and propofol group 33 years
Average
weight
- ketofol group 54 kg while in propofol group 55 kg
Duration
of surgery
- 37 minutes in ketofol group
in propofol group 35 minutes
Average
frequency of incremental dose - ketofol group = two
propofol group = four
Average
total dose of propofol - in ketofol group = 50 mg
in propofol group = 270 mg
Hemodynamics
Pulse
rate
- No patients in ketofol group had fall in pulse rate. 77% patients in Propofol
group had decreased in pulse rate (< 10% of baseline).
Blood
pressure
- No patients in ketofol group had significant fall in both systolic &
diastolic pressure. 55% patients in propofol grup had fall in blood pressure,
both systolic & diastolic (20% of baseline).
Recovery:
Patients
in ketofol group showed early arousal than prpofol group.
Mood
state
- In ketofol group, patient showed more positive mood state in terms of
elation, composure, agreeable and clear headed than propofol group.
MMSE
score
- Patients in ketofol group showed prompt recovery of cognitive function than
propofol group.
Side
effects
1. Incidence
apnea and hypoventilation were higher in ketofol group as compare to propofol
group
2.
8% patients in propofol group had hypotension
and no patients in ketofol group had hypotension.
3. 7%
patients in ketofol group had emergence reaction.
Conclusion - Till
now, as per results, ketofol can be an alternative to propofol for TIVA in
terms of hemodynamic stabilityand early recovery of cognitive function. But
ketofol is associated with higher incidence of respiratory depression and
emergence reaction.
Future
target
– study is still in progress and report will be updated latter. |