| CTRI Number |
CTRI/2018/05/013885 [Registered on: 14/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the effect of dexmedetomidine for general anaesthesia considering the weight of the patient |
|
Scientific Title of Study
|
A prospective randomised comparative study to evaluate the effect of dexmedetomidine based on total 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
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
Hillside Avenue, Hiranandani Gardens, Powai
Mumbai
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
meenoti@gmail.com |
|
Details of Contact Person
Public 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
Hillside Avenue, Hiranandani Gardens, Powai
Mumbai
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
meenoti@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 |
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 Hiranandani Hospital |
Dr L H Hiranandani Hospital 2nd floor, Operation Theatre 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 of 30kg/m2 and above, undergoing elective laparoscopic surgery under general anaesthesia for atleast 30 minutes and maximum of 3 hours , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous dexmedetomidine |
Intravenous dexmedetomidine calculated as per the Ideal Body weight as a bolus dose of 1microgram/kg prior to induction of anaesthesia followed by infusion dose of 0.05 microgram/kg/hr for maintenance of general anaesthesia throughout the duration of surgery |
| Comparator Agent |
Intravenous dexmedetomidine |
Intravenous dexmedetomidine calculated as per the Total Body weight as a bolus dose of 1microgram/kg prior to induction of anaesthesia followed by infusion dose of 0.05 microgram/kg/hr for maintenance of general anaesthesia throughout the duration of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients undergoing elective laparoscopic surgery 2 With BMI between 30kg/m2 and above
3 ASA 1and 2 under general anaesthesia
4 Duration of 30 minutes to maximum of 3 hours
5 Informed consent |
|
| 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 dexmedetomidine .
5. Patients with significant hemodynamic changes intraoperatively, fall of Mean arterial blood pressure by more than 20% of baseline,
6. Intraoperative entropy of more than 60 for more than 10 minutes
|
|
|
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 dose of intravenous dexmedetomidine for the haemodynamic stability during general anaesthesia during the duration of laprascopic surgery |
Intraoperatively during surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Recovery parameters like
1 Sedation score post extubation
2 Time for extubation after stoping dexmedetomidine infusion
3. Time for eye opening after stopping dexmedetomidine infusion
4. Time for obeying oral commands after stopping dexmedetomidine infusion
5. Time to achieve entropy values more than 90 after stopping dexmedetomidine infusion
6. Consumption of sevoflurane at the end of surgery |
1. Sedation score - post extubation
2. Time for extubation - time required after stopping dexmedetomidine infusion to the time of extubation
3. Time for eye opening after stopping dexmedetomidine infusion to the time of extubation
4. Time for obeying oral commands after stopping dexmedetomidine infusion to the time of extubation
5. Time taken to achieve entropy values more than 90 after stopping dexmedetomidine infusion
6. Consumption of sevoflurane at the end of surgery |
|
|
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 4 |
|
Date of First Enrollment (India)
|
01/03/2016 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is prospective randomised comparative study to evaluate optimal intravenous dose of dexmedetomidine ( bolus and maintenance) based on total body weight and ideal body weight for laparoscopic surgeries. Many drugs behave differntly in obese and non obese patients, the reason being both pharmacokinetics and pharmacodynamics properties of drugs. Dexmedetomidine may have varied effects in obese and non obese patients. There is no common consensus or literature retgarding correct weight scalar for dosing dexmedetomidine. There is no proportionate linear relationship in the increament of total body weight , adipose tissue and other body compartments like muscle , tissues etc. The volume of distribution also different and thus the drug dosing differs in obese patients. Hence we would like to evaluate the best weight scalar for bolus and maintenance dose of dexmedetomidine. |