| CTRI Number |
CTRI/2017/10/010044 [Registered on: 09/10/2017] Trial Registered Prospectively |
| Last Modified On: |
06/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to evaluate the dose of propofol for general anaesthesia considering the weight of the patient |
Scientific Title of Study
Modification(s)
|
A prospective randomised comparative study to evaluate optimal induction and
maintenance dose of propofol according to total body weight,lean body weight and ideal body weight. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenoti Potdar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Dr L H Hiranandani Hospital |
| Address |
Dr L H Hiranandani Hospital
Department of Anaesthesia
Hillside Avenue, Hiranandani Gardens, Powai, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
meenoti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenoti Potdar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Dr L H Hiranandani Hospital |
| Address |
Dr L H Hiranandani Hospital,
Department of Anaesthesia
Hillside Avenue, Hiranandani Gardens, Powai, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
meenoti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Gaikwad |
| Designation |
DNB Aneasthesia Resident |
| Affiliation |
Dr L H Hiranandani Hospital |
| Address |
Dr L H Hiranandani Hospital
Department of Anaesthesia
Hillside Avenue, Hiranandani Gardens, Powai, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9168068441 |
| Fax |
|
| Email |
drmanishagaikwad111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr L H Hiranandani Hospital
Hillside Avenue
Hiranandani Gardens
Powai, Mumbai 400076 |
|
|
Primary Sponsor
|
| Name |
Dr L H Hiranandani Hospital |
| Address |
Dr L H Hiranandani Hospital, Hillside Avenue, Hiranandani Gardens, Powai, Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Meenoti Potdar |
Dr L H Hiranadani Hospital |
Opertion theatre, 2nd floor
Hillside Avenue
Hiranandani Gardens
Powai Mumbai-400076
Mumbai (Suburban)
MAHARASHTRA |
9920627839
meenoti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Dr L H Hiranandani Hospital Powai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA I & II patients, between age group18-60yrs with BMI (30-40kg/m2), undergoing elective laparoscopic surgery under general anaesthesia for atleast 30 minutes and maximum of 3 hours
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous propofol |
The dose of intravenous propofol calculated as per the Ideal Body weight as a bolus at induction and infusion for maintenance of general anaesthesia throughout the duration of surgery |
| Intervention |
Intravenous propofol |
The dose of intravenous propofol calculated as per the Lean Body weight as a bolus at induction and infusion for maintenance of general anaesthesia throughout the duration of surgery |
| Comparator Agent |
Intravenous Propofol |
The dose of propofol calculated as per the Total Body weight at induction and for maintenance of general anaesthesia throuhout the duration of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective laparoscopic surgery with BMI between 30 and 40, ASA 1and 2 under general anaesthesia for a minimum duration of 30 minutes to maximum of 3 hours
|
|
| ExclusionCriteria |
| Details |
1.History of significant cardiac pulmonary, liver or renal disease.
2. Patient scheduled for awake bronchoscopic intubation.
3. Previous history of cerebrovascular accident, other neurological disorders and those on long term drugs affecting CNS (chronic BZD’s/ opioids)
4. Allergy to propofol.
5. Patients with significant hemodynamic changes intraoperatively, fall of Mean arterial blood pressure by more than 20% of baseline,intraoperative entropy of more than 60 for more than 10 minutes and need to add inhalational agent will be excluded.
6) patients refusal to be included in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The ideal weight scalar for assessing the dose of propofol for induction and maintanence of total intravenous general anaesthesia in laprascopic surgery |
Industion dose- after one minute of injection of the bolus dose of intravenous propofol at induction of anaesthesia
maintenance dose- the average infusion dose for maintenance of anaesthesia with intravenous propofol throughout the duration of surgery, calculated at the end of the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Recovery parameters like
1 Sedation score post extubation
2 Time for extubation after stoping propofol infusion
3. Time for eye opening after stopping propofol infusion
4. Time for obeying oral commands after stopping propofol infusion
5. Time to achieve entropy values more than 90 after stopping propofol infusion |
After stopping propofol infusion
1. Sedation score - post extubation
2. Time for extubation - time required after stopping propofol infusion to the time of extubation
3. Time for eye opening after stopping propofol infusion to the time of extubation
4. Time for obeying oral commands after stopping propofol infusion to the time of extubation
5. Time taken to achieve entropy values more than 90 after stopping propofol infusion |
|
|
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 4 |
|
Date of First Enrollment (India)
|
20/10/2017 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective randomised comparative study to evaluate optimal induction and maintenance dose of propofol according to total body weight, lean body weight and ideal body weight under total intravenous general anaesthesia for laprascopic surgery. Many drugs behave differently in obese and non obese patients the reasons being both pharmacokinetics and pharmacodynamics properties of the drugs. Propofol is highly lipophilic agent and may have varied effects in the obese and the non obese patients. There is no common consensus or literature regarding correct weight scalar for dosing propofol. Presently propofol is administered by the total body weight which may be a very high dosage for obese patients. There is no proportionate linear relationship in the increment of total body weight, adipose tissue and the other body compartment like muscle, tissues etc. The volume of distribution also is different and thus the drug dosing differs in obese patients. Hence we would like to evaluate the best weight scalar for dosing propofol for induction and maintenance of total intravenous general anaesthesia. |