| CTRI Number |
CTRI/2017/01/007699 [Registered on: 13/01/2017] Trial Registered Retrospectively |
| Last Modified On: |
18/06/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of general anaesthesia using Desflurane at low flow (1 L/min)and medium flow rates (2L/min) |
|
Scientific Title of Study
|
Comparison of low (1 L/min) with medium (2 L/min) flow anaesthesia using Desflurane:
effects on Oxygen concentration, Desflurane consumption and recovery profile |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Kundu |
| Designation |
Post graduate student |
| Affiliation |
PGIMER, Dr. Ram Manohar Lohia Hospital |
| Address |
Room No 415, Resident Doctors Hostel, Dr. Ram Manohar Lohia Hospital, New Delhi.
Baba Kharak Singh Marg, New Delhi- 110001.
Central
DELHI
110001
India |
| Phone |
7042068660 |
| Fax |
|
| Email |
anjali.kundu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neerja Banerjee |
| Designation |
Associate Professor |
| Affiliation |
PGIMER, Dr. Ram Manohar Lohia Hospital |
| Address |
40/203, First floor, Chittaranjan Park, New Delhi-19.
Baba Kharak Singh Marg, New Delhi- 110001
South
DELHI
110019
India |
| Phone |
9810517575 |
| Fax |
|
| Email |
neerja.banerjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neerja Banerjee |
| Designation |
Associate Professor |
| Affiliation |
PGIMER, Dr.Ram Manohar Lohia Hospital |
| Address |
40/203, First floor, Chittaranjan Park, New Delhi-19
Baba Kharak Singh Marg, New Delhi- 110001.
South
DELHI
110019
India |
| Phone |
9810517575 |
| Fax |
|
| Email |
neerja.banerjee@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER DR RAM MANOHAR LOHIA HOSPITAL |
| Address |
BABA KHARAK SINGH MARG, NEW DELHI- 110001 |
| 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 Anjali Kundu |
Dr.Ram Manohar Lohia Hospital |
Department of Anaesthesiology, Room no. 301, Academic Block, PGIMER, Dr. Ram Manohar Lohia Hospital, Baba Kharak Singh Marg, New Delhi-110001.
Central
DELHI |
7042068660
anjali.kundu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.Ram Manohar Lohia Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
American Society of Anesthesiologists status I and II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1 L/min |
Desflurane anaesthesia with fresh gas flow of 1 L/min |
| Comparator Agent |
2 L/min |
Desflurane anaesthesia with fresh gas flow of 2 L/min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA status I and II.
2.Age group 18 to 60 years.
3.Posted for elective surgery under general anaesthesia.
4.Duration of the anaesthesia 90 to
180 minutes approximately
|
|
| ExclusionCriteria |
| Details |
1.Laparoscopic surgery.
2.Pregnancy.
3.Obesity with BMI > 30. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the inspired and expired oxygen and desflurane concentrations in low flow(1 L/min) with medium flow (2 L/min) desflurane anaesthesia |
Baseline(pre operative)
10 mins
20 mins
30 mins
60 mins
90 mins
120 mins
150 mins
180 mins
ABG- Baseline
20 mins after switching to low flow
20 mins before reversal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the recovery profile and desflurane consumption of the patients of low flow (1 L/min) with medium flow (2 L/min) desflurane anaesthesia |
MODIFIED ALDRETE SCORE -
5 mins
15 mins
30 mins |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/03/2015 |
| 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="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Yet to be published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Low flow anaesthesia is defined as any technique where the fresh gas flow is less than the alveolar ventilation.Low solubility inhalational anaesthetic agents and high precision monitoring techniques have enabled modern day anaesthesiologists to employ low flow anaesthesia on a daily basis.Therefore we planned to conduct this study to determine the efficacy of low flow Desflurane anaesthesia by comparing the effects of low flow Desflurane anaesthesia (1 L/min) with those of medium flow anaesthesia (2L/min) on Oxygen and Desflurane concentration, Desflurane consumption and recovery profile.
After obtaining approval from the institutional ethics committee, a randomised controlled study with two groups of patients(30 in each) of Low flow (1L/min) and Medium flow(2L/min) anaesthesia was conducted, comparing inspired and expired Oxygen and Desflurane concentrations, recovery profile of patients and Desflurane consumption between the two.
The parameters monitored in both the groups were heart rate, blood pressure, mean arterial pressure, pulse oximetry,nasopharyngeal
temperature,capnography,inspired and expired concentrations of Oxygen, inspired and expired
concentrationsof Nitrous oxide, inspired
and expired concentrations of Desflurane,minimum alveolar concentration, bispectral index,arterial blood gas analysis. Modified Aldrete score was used for assessing recovery profile and total Desflurane consumption was calculated.
Based on the values of the above mentioned parameters the statistical analysis shall be formulated using the student’s t test and a p value of <0.05 will be considered statistically significant.
|