| CTRI Number |
CTRI/2018/01/011630 [Registered on: 31/01/2018] 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, Active Controlled Trial |
|
Public Title of Study
|
Comparision of two intravenous induction drugs on quality of intraoral device insertion, pulse, BP chnges and recovery |
|
Scientific Title of Study
|
Clinical comparision of ketofol(ketamine and propofol admixture)versus propofol on quality of I-gel insertion, hemodynamic stability and recovery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smita R Engineer |
| Designation |
Associate professor |
| Affiliation |
B.J.Medical College, Civil Hospital, Ahmedabad, Gujarat |
| Address |
F3, 1st floor, department of anesthesiology, B.J.Medical College, Civil Hospital, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
|
| Fax |
|
| Email |
seng_90@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita R Engineer |
| Designation |
Associate professor |
| Affiliation |
B.J.Medical College, Civil Hospital, Ahmedabad |
| Address |
F3, 1st floor, Department of anesthesiology, B.J.Medical College, Civil Hospital, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
|
| Fax |
|
| Email |
seng_90@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita R Engineer |
| Designation |
Associate professor |
| Affiliation |
B.J.Medical College, Civil Hospital, Ahmedabad |
| Address |
F3, 1st floor, Department of anesthesiology, B.J.Medical College, Civil Hospital, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
|
| Fax |
|
| Email |
seng_90@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Health and family welfare department of government of gujarat, Gandhinagar |
|
|
Primary Sponsor
|
| Name |
Government of gujarat |
| Address |
Health and family welfare department, Gandhinagar |
| 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 Smita R Engineer |
Civil Hospital |
F3, 1st floor, Main surgery operation theatre, Civil Hospital, Asarwa, Ahmedabad
Ahmadabad
GUJARAT |
9825504948
seng_90@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| The institutional ethics committee B.J.Medical College & Civil Hospital, Ahmedabad |
Approved |
| 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 |
Ameican society of anesthesiologist grade I,II,III grades , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
comparing I gel insertion condition |
Group P: Intravenous Inj. Propofol 2.5mg/kg
Group KP: Intravenous Inj. Ketamine 1mg/kg and propofol 2mg/kg. Injected drug will be prepared in 20 ml syringe and one 10 ml syringe for rescue if needed. Appropriate size I gel or LMA will be inserted after loss of consciousness and eye lid reflex by an anesthetist. |
| Comparator Agent |
hemodynamic changes, postoperative recovery of the patient and side effects. |
Group P: IV Inj. Propofol 2.5mg/kg
Group KP: IV Inj. Ketamine 1mg/kg and propofol 2mg/kg
Injected drug will be prepared in 20 ml syringe and one 10 ml syringe for rescue if needed. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I-IV
2. Patients who required general anesthesia
|
|
| ExclusionCriteria |
| Details |
1. ASA status V
2. Hypersensitivity reaction to study drug, soyabean oil, glycerol, egg lecithin
3. Pregnant or lactating patients
4. Neonates and infants
5. Patients with history of neurologic and psychiatric diseases
6. Difficult airway
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Overall insertion conditions –
excellent / satisfactory / poor |
Appropriate size I gel or LMA will be inserted after loss of consciousness and eye lid reflex. Assessments will be done only for the first attempt. duration five minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| observing hemodynamic parameters, recovery and complications |
observation till end of surgery. duration of 60minutes. |
|
|
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 1 |
|
Date of First Enrollment (India)
|
12/02/2018 |
| 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="0" |
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)
|
Propofol is a nonopioid, nonbarbiturate, sedative-hypnotic agent with rapid induction and recovery times and antiemetic effects. propofol (diprivan , 2,6-di-isopropylphenol) is most preferred induction agent for insertion of supralaryngeal device as it allows easy insertion by depressing airway reflexes. Main disadvantage with propofol is dose-related cardio-respiratory depression and pain during bolus intravenous injection. Ketamine causes little or no cardio-respiratory depression. Its use is limited by emergence hallucinations, elevation of blood pressure and heart rate due to its sympathomimetic effects, and increased intracranial pressure. Effectiveness of combination of propofol and ketamine (ketofol) has been recently demonstrated and may provide a novel induction agent with favorable hemodynamics and reduced side effects attributed to either drug.
Uploaded Summary during study Till now 45 patients in ketofol group (group KP) and 40 patients in propofol (group P) group has been evaluated. Demographic data - Mean age (years): group P - 29.94, Group KP - 32.5 Mean weight (kg): group P - 50.02, Group KP - 52.36 Male:female - group P - 12:33, Group KP - 23:17 Mean duration of Surgery (min): group P - 33.5, Group KP - 36.5 Mean time for loss of consciousness (secs): group P – 43, Group KP – 37 I gel insertion conditions: Coughing/gagging: Nil - group KP all patients, group P 35 patients, Slight - group P 05 patients Jaw relaxation: Excellent - group KP all patients, group P 35 patients, satisfactory – group P 05 patients Head and neck movements: Nil – group KP all patients, group P 38 patients, slight – group P 02 patients Ease of insertion: Easy – group KP all patients, group P 31 patients, difficult – group P 09 patients Overall insertion condition: Excellent – group KP all patients, group P 45 patients, satisfactory – 05 patients
Complications: Pain on injection – 30 patients in group P, 05 patients in group KP Hypotension – 15 patients in group P, 05 patients in group KP Bradycardia – 08 patients in group P, 03 patients in group KP Apnea – 04 patients in group P, 10 patients in group KP Hypoventilation - 08 patients in group P, 02 patients in group Study still continued. |