| CTRI Number |
CTRI/2017/12/010910 [Registered on: 18/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
30/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Changes in lung function after total injectable anaesthesia and balanced
anaesthesia with desflurane |
|
Scientific Title of Study
|
A prospective randomized study to evaluate and compare changes in lung function parameters after total intravenous anaesthesia and balanced
anaesthesia with desflurane |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
saurabh sharma |
| Designation |
Resident in Anesthesiology |
| Affiliation |
Maulana Azad Medical College and associated LN Hospital |
| Address |
Room no 312, BL Taneja block, Department of Anesthesiology Maulana Azad Medical College and associated Lok Nayak Hospital, bsz marg, new delhi 02
110002
Dr Raktima Anand, BL Taneja block, Department of Anesthesiology Maulana Azad Medical College and associated Lok Nayak Hospital, bsz marg, new delhi 02
110002
raktima.anand@gmail.com
New Delhi
DELHI
110002
India |
| Phone |
8921816041 |
| Fax |
|
| Email |
ssharmambbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAKTIMA ANAND |
| Designation |
Resident in Anesthesiology |
| Affiliation |
Maulana Azad Medical College and associated LN Hospital |
| Address |
Dr Raktima Anand, BL Taneja block, Department of Anesthesiology Maulana Azad Medical College and associated Lok Nayak Hospital, bsz marg, new delhi 02
110002
raktima.anand@gmail.com
New Delhi
DELHI
110002
India |
| Phone |
8921816041 |
| Fax |
|
| Email |
raktima.anand@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAURABH SHARMA |
| Designation |
Resident in Anesthesiology |
| Affiliation |
Maulana Azad Medical College and associated LN Hospital |
| Address |
Room no 312, BL Taneja block, Department of Anesthesiology Maulana Azad Medical College and associated Lok Nayak Hospital, bsz marg, new delhi 02
110002
email:ssharmambbs@gmail.com
New Delhi
DELHI
110002
India |
| Phone |
8921816041 |
| Fax |
|
| Email |
ssharmambbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Intensive Care,
Maulana Azad Medical College, BSZ marg, New Delhi, PIN 110002 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology and Intensive Care Maulana Azad Medical College |
| Address |
BSZ marg, new delhi 02
110002 |
| 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 |
| Saurabh Sharma |
Lok Nayak Hospital |
Department of Anesthesiology and Intensive Care, Maulana Azad Medical College, BSZ marg, new delhi 110002
New Delhi
DELHI |
8281805880
8921816041
ssharmambbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| maulana azad medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ï‚· ASA physical status I and II.
ï‚· Patients in the age-group 18-60 years undergoing mastoid surgery., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
effect of balanced anaesthesia with desflurane on postoperative pulmonary function test |
A preoperative pulse-oximetry and spirometry was done in thirty patients undergoing mastoid
surgery. And they were allocated into group B (balanced anesthesia
with desflurane). In this group, anaesthesia was induced with
propofol, rocuronium and fentanyl. Maintenance of anesthesia was done with
desflurane ,nitrous oxide in oxygen.
Postoperatively pulse-oximetry and spirometry was done at 1, 3 and 24 hour after extubation. |
| Intervention |
total intravenous anaesthesia |
A preoperative pulse-oximetry and spirometry was done in thirty patients undergoing mastoid
surgery. And they were allocated into group T (TIVA). In this group, anaesthesia was induced with
propofol, rocuronium and fentanyl. Maintenance of anesthesia in group T with propofol and fentanyl infusion.
Postoperatively pulse-oximetry and spirometry was done at 1, 3 and 24 hour after extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status I and II.
2. Patients in the age-group 18-60 years undergoing mastoid surgery. |
|
| ExclusionCriteria |
| Details |
1. BMI > 30 kg/m2
2. History of smoking
3. Cardiopulmonary disease
4. Obstructive sleep apnoea syndrome
5. Pregnancy
6. Kypho-scoliosis
7. Neuromuscular disorder.
8. Patients who were uncooperative, unable to perform spirometry or mentally retarded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
change in forced expiratory volume in first second
(FEV1) |
1, 3 and 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome measures were changes in peak expiratory flow rate (PEFR), forced
vital capacity (FVC), mid expiratory flow rate at 25 to 75% of vital capacity manoeuvre
(MEF 25-75) and peripheral oxygen saturation (SpO2) |
1, 3 and 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2013 |
| Date of Study Completion (India) |
28/02/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet sent for publication. waiting for CTRI registration number |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A decrease in respiratory parameters in the immediate postoperative period has
been found both after general and regional anaesthesia.Propofol decreases upper airway tone
unlike the volatile anaesthetics and there is a lesser incidence of coughing in patients
receiving total intravenous anesthesia (TIVA) with propofol as compared to balanced
anesthesia withdesflurane. Since coughing is similar to a vital capacity manoeuvre and may
be effective in reducing atelectasis postoperatively.
Material and Method The study was a prospective, randomised, controlled trial to
investigate whether balanced anaesthesia using desflurane and total intravenous anesthesia
(TIVA) withpropofol, have different effects on the postoperative impairment of respiratory
function after general anesthesia in patients for up to twenty four hours after a peripheral
surgery.
A preoperative pulse-oximetry and spirometry was done in sixty patients undergoing mastoid
surgery. And they were allocated into 2 groups of thirty each: Group B (balanced anesthesia
with desflurane) and Group T (TIVA). In both the groups, anaesthesia was induced with
propofol, rocuronium and fentanyl. Maintenance of anesthesia in group B was done with
desflurane ,nitrous oxide in oxygen; and in group T with propofol and fentanyl infusion.
Postoperatively pulse-oximetry and spirometry was done at 1, 3 and 24 hour after extubation.
Results There was a definite and similar decrease in lung function parameters (FEV1, FVC,
MEFR, PEFR andSpO2) after both balanced anesthesia with desflurane and TIVA. However
FEV1/FVC was not altered after both the modalities of general anesthesia.FEV1and SpO2
remained depressed for upto twenty four hours followed up. FVC recovered to near
preoperative value after twenty four hours of TIVA with propofol, but continued to remain
depressed after twenty four hours (followed up) of balanced anesthesia with desflurane.
MEFR recovered to near preoperative values after 3 hours of balanced anesthesia with
desfluraneand after 24 hours of TIVA with propofol. PEFR recovered to near preoperative
value after twenty four hours of TIVA with propofol, but continued to remain depressed after
twenty four hours (followed up) of balanced anesthesia with desflurane.
Conclusion TIVA with propofol is not associated with greater reduction in pulmonary
function parameters as compared with balanced anesthesia with desflurane in ASA I & II
patients without coexisting cardiopulmonary disease,obesity or pregnancyafter a peripheral
surgery not involving airway, thorax or abdomen.
|