| CTRI Number |
CTRI/2018/02/012057 [Registered on: 21/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
24/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Total Intravenous Anaesthesia: Comparison of two drug combinations Propofol-Ketamine and Propofol-Dexmedetomidine combinations in Total intravenous anaesthesia to evaluate the induction characteristics, maintenance of anaesthesia and recovery characteristics & Side effects. |
|
Scientific Title of Study
|
Total Intravenous Anaesthesia: Comparison of Propofol-Ketamine and Propofol-Dexmedetomidine combinations |
| Trial Acronym |
TIVA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kanhaiya Lal Kishnani |
| Designation |
Assistant Professor |
| Affiliation |
Peoples College of Medical Sciences & Research Centre |
| Address |
Peoples College of Medical Sciences & Research Centre Bhanpur Bhopal
Same as address 1
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07554004010 |
| Fax |
|
| Email |
drkishnani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanhaiya Lal Kishnani |
| Designation |
Assistant Professor |
| Affiliation |
Peoples College of Medical Sciences & Research Centre |
| Address |
Peoples College of Medical Sciences & Research Centre Bhanpur Bhopal
Same as address 1
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07554004010 |
| Fax |
|
| Email |
drkishnani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanhaiya Lal Kishnani |
| Designation |
Assistant Professor |
| Affiliation |
Peoples College of Medical Sciences & Research Centre |
| Address |
Peoples College of Medical Sciences & Research Centre Bhanpur Bhopal
Same as address 1
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07554004010 |
| Fax |
|
| Email |
drkishnani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples College of Medical Sciences and Research Centre Bhanpur Bhopal. |
|
|
Primary Sponsor
|
| Name |
Peoples College of Medical Sciences |
| Address |
Peoples college of Medical Sciences and research Centre Bhanpur Bhopal |
| 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 Kanhaiya Lal Kishnani |
Peoples College of Medical Sciences |
Peoples college of Medical Sciences And research Center Bhanpur Bhopal
Bhopal
MADHYA PRADESH |
07554004010
07554004010
drkishnani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Peoples College of Medical Sciences Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing sergical procedures PAC fit, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
The comparison of two combinations 1)Propofol and Ketamine 2) Propofol and Dexmedetomedine. |
Induction of anesthesia will be done in group 1) with Propofol 1.0 mg/Kgbwt and Ketamine 1.0 mg body wt in group 2) with Propofol 1.0 mg/ body wt and Dexmedetomedine 1.0 mg body wt. Maintenance with Propofol 2.0 mg and Ketamine 2.0 mg per kg per hour in group 1) and with Propofol 2.0 mg and Dexmedetomedine 0.7 mg per kg per hour in gropup 2). |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
100 adult patients with ASA Gr I-II between age of 18 to 65 years of age willing for participation in study after explanation of study undergoing short surgical procedures will be includd.They will be devided in two groups 1) group will receive Propofol- Ketamine. combination and group 2) will receive Propofol Dexamedetomedine combination. One capsule of Omeprazole 20 mg and one tab of Alprozolam 0.25 mg given at 10.00 PM previous night of procedure.IV fluid Ringer Lactate will be given for fluid resuscitation. Inductio of anesthesia will be done ingroup 1) with Propofol 1.0 mg/Kgbwt and Ketamine 1.0 mg body wt in group 2) with Propofol 1.0 mg/ bodt wt and Dexmedetomedine 1.0 mg body wt. Maintenance with Propofol 2.0 mg and Ketamine 2.0 mg per kg per hour in group 1) and with Propofol 2.0 mg and Dexmedetomedine 0.7 mg per kg per hour in gropup 2). The vital parameters will be observed during operative procedure and postoperative period. The patients will be followed up for any symptoms and signs and vitals recorded in recovery room. |
|
| ExclusionCriteria |
| Details |
Patients who didnot give consent for participation. Patients with H/O allergy to any particular drug, allergy to egg or fat, on MAO inhibitors, H/O Liver disorder like jaundice etc. Pregnant woman and patients for long surgeries not included in study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Parameters SpO2, NIBP, ECG and heart rate monitored at interval of 5 min for initial 15 min and then every 10 min interval till end. Patients in both groups were ventilated with 100% Oxygen through circuit attached to circle absorber.
All patients in both groups were monitored and followed up in post operative period for any symptoms. The vitals were recorded at 15 min interval in recovery room. It was presumed to have some changes in parameters.
|
Side effects if any with the combinations. Change in vital parameters during procedures and in immediate post operative period were noted |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There was slight increase in pulse rate in both groups,insignificant change in Blood Pressure,time of drowsiness was more in Ketamine group,nausea and vomiting were comparable in both |
There was slight increase in pulse rate in both groups which persisted for brief period of 35 min.,insignificant change in Blood Pressure,time of drowsiness was more in Ketamine group in recovery period, nausea and vomiting were comparable in both |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
06/11/2017 |
| 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) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not sent for publication yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of study to compare efficacy,safety and stability of vitals of two drug combinations I.V. Propofol -Ketamine and Propofol- Dexmedetomedine in Total Intravenous anaesthesia. The study to compare induction characteristics, maintenance of anaesthesia, recovery characteristics with these combinations. Side effects if any. Total 100 patients between age 20 to 65 yrs belonging to ASA gr I & II of either sex undergoing short surgical procedure are being included for this study.They are divided into two groups of 50 patients each. Group I(PK) received Propofol-Ketamine combination and Group II(PD) received Propofol-Dexmedetomedine combination. Exclusion:-The patients with any drug allergy,allergy to egg or fat, on MAO inhibitors, with H/O liver disease, pregnant females and patients for long duration surgery not included. All patients receiving 20 mg Omeprazole and 0.25 mg of Alprozolam at 10.00 PM previous night of surgery. l Patients preloaded with I/V Ringer Lactate solution 15ml/kg body weight. Intraoperative fluid rescusitation by Ringer Lactate solution as formula of 4 ml/kg for first 10 kg body weight, 2 ml/kg for next 10 kg and 1ml/kg for remaining body weight.. 50% of this calculated fluid in first hour and remaining in second hour. Monitoring of all the patients for heart rate, SpO2, ECG and NIBP through out the procedure and in post operative period in recovery room. They are requested to inform any symptom in post operative period. In group I induction with Propofol 1.0 mg/KgBwt and Ketamine 1.0 mg /kgBwt and in group II with I/V Propofol 1.0 mg/KgBwt and Dexmedetomedine 1.0. mcg/kgBwt. The drugs loaded by separate person not involved in study, the observations are noted by separate person not involved in study. The maintenance of anesthesia done with I.V. Propofol 2.0 mg/kgBwt/hr and Ketamine 2.0mg/KgBwt/hr by infusion pump in group I and with I.V. Propofol 2.0mg/kgBwt/hr and Dexmetomedine 0.7 mcg/kgBwt/hr by infusion pump in group II. Vital parameters like heart rate, NIBP, SpO2,ECG monitored continuously during procedure. The observation for any symptoms if any during procedure. The recording of vitals during post operative period in recovery room. Patients are requested to inform any symptom arising in this period. The data obtained will be analyzed. |