| CTRI Number |
CTRI/2017/11/010546 [Registered on: 17/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
17/11/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Amount of desflurane used at three different flow rates |
|
Scientific Title of Study
|
Comparison of efficacy and evaluation of the optimal flow rate for desflurane anaesthesia at three different settings |
| 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. Lakhumal Hiranand Hiranandani Hospital |
| Address |
Department of Anaesthesia,
Hiranandani Gardens, Hillside Avenue, Powai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
meenoti@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenoti Potdar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Dr. Lakhumal Hiranand Hiranandani Hospital |
| Address |
Department of Anaesthesia,
Hiranandani Gardens, Hillside Avenue, Powai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
meenoti@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenoti Potdar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Dr. Lakhumal Hiranand Hiranandani Hospital |
| Address |
Department of Anaesthesia,
Hiranandani Gardens, Hillside Avenue, Powai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
meenoti@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr L H Hiranandani Hospital |
|
|
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 |
| Meenoti Potdar |
Operation theatre |
Dr L H Hiranandani Hospital 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 Grade I and 2, non pregnant patients, of both sexes, in the age group of 18 to 70 years, consenting for general anaesthesia for laprascopic surgery lasting for 30 minutes to 3 hours, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Desflurane at 0.5 litres of flow rate for maintenance of general anaesthesia |
General anaesthesia would be maintained by titrating desflurane at a flow rate of 0.5 litres to maintain an entropy value between 40-60. |
| Intervention |
Desflurane at 1 litres of flow rate for maintenance of general anaesthesia |
General anaesthesia would be maintained by titrating desflurane at a flow rate of 1 litres to maintain an entropy value between 40-60. |
| Comparator Agent |
Desflurane at 1.5 litres of flow rate for maintenance of general anaesthesia |
General anaesthesia would be maintained by titrating desflurane at a flow rate of 1.5 litres to maintain an entropy value between 40-60. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA 1 and 2 patients undergoing General anaesthesia for laprascopic abdominal and pelvic
surgeries
2. Surgeries lasting approximately 30 minutes to 180 minutes
3. Patients giving valid consent
4. Age:18 to 70 year
|
|
| ExclusionCriteria |
| Details |
•Patient refusal
•ASA grade >2
•Chronic alcoholics/ smokers, acute alcohol intoxication
•Pregnant women
•Patients with neuromuscular diseases
•Suspected Malignant hyperthermia
•Persons with epidural analgesia catheter
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of desflurane with respect to maintenance haemodynamic parameters and depth of anaesthesia |
At all time points intraoperatively after starting desflurane to switching off desflurane |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Safety of low flow rates assessed by oxygenation of the patient
2. Incidence of awareness under anaesthesia
3. Consumption of desflurane
4. Recovery parameters of the patient after stopping desflurane like time for extubation, time for response to oral commands and time taken for eye opening |
1. Throughout intraoperatively
2. Post operatively in the recovery room and after 24 hours
3. After stopping desflurane
4. After stopping desflurane |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/07/2015 |
| 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 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is conducted to evaluate the optimal flow rate for using desflurane at low flows, its efficay for maintenance of depth of anaesthesia and haemodynamic stability. We would like to evaluate that by decreasing the flow rates does the consumption of desflurane actually reduces. We would also like to highlight the safety of oxygenation with low flow rates and the recovery out come of the patient post stopping desflurane. |