| CTRI Number |
CTRI/2020/05/024987 [Registered on: 04/05/2020] Trial Registered Prospectively |
| Last Modified On: |
20/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
A study aimed to evaluate and compare the effect of nebulisation with two different doses of fluticasone drug before starting anaesthesia, on the occurrence and severity of sore throat (throat pain) in patients undergoing general anaesthesia with endotracheal tube. |
|
Scientific Title of Study
|
Comparative evaluation of preoperative nebulisation with two doses of fluticasone for postoperative sore throat in patients undergoing general anaesthesia with endotracheal intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NARESH KUMAR GAUTAM |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL |
| Address |
B-2/34, BUDH VIHAR, PHASE-1, NEW DELHI
South
DELHI
110029
India |
| Phone |
08076370174 |
| Fax |
|
| Email |
doctornakul04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti Jain |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, VMMC and SJH, Delhi
South
DELHI
110029
India |
| Phone |
9212308441 |
| Fax |
|
| Email |
shruti.anaesth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Naresh Kumar Gautam |
| Designation |
Postgraduate Student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, VMMC and SJH, Delhi
South
DELHI
110029
India |
| Phone |
08076370174 |
| Fax |
|
| Email |
doctornakul04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Delhi |
|
|
Primary Sponsor
|
| Name |
Naresh Kumar Gautam |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Delhi |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Naresh Kumar Gautam |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Main OT block, Department of Anaesthesia
South
DELHI |
8076370174
doctornakul04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: N200||Calculus of kidney, (3) ICD-10 Condition: N731||Chronic parametritis and pelvic cellulitis, (4) ICD-10 Condition: N800||Endometriosis of uterus, (5) ICD-10 Condition: N972||Female infertility of uterine origin, (6) ICD-10 Condition: N132||Hydronephrosis with renal and ureteral calculous obstruction, (7) ICD-10 Condition: N839||Noninflammatory disorder of ovary,fallopian tube and broad ligament, unspecified, (8) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, (9) ICD-10 Condition: N838||Other noninflammatory disorders ofovary, fallopian tube and broad ligament, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison with Normal Saline group will be done. |
Control group patients will be nebulised with 5ml of Normal Saline Pre-operatively for 10 minutes with nebulisation mask connected to oxygen source and this group will be compared with the drug groups. |
| Intervention |
Nebulisation with Fluticasone drug in two different doses. |
Preoperative nebulisation with Fluticasone drug solution in three groups. One group will be nebulised with 250mcg diluted to 5ml, another group will be nebulised with 500mcg solution diluted to 5ml and and the last group with Normal Saline 5ml. The nebulisation will be done with nebulisation mask connected with oxygen source and will be for 10 minutes only. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) PHYSICAL STATUS 1 AND 2
UNDERGOING LAPAROSCOPIC SURGERIES |
|
| ExclusionCriteria |
| Details |
1. Patient with anticipated difficult airway.
2. Patients with history of preoperative sore throat, oral surgeries, asthma, COPD, diabetes, head and neck surgeries.
3.Patients with known allergies to study drugs and rescue drugs.
4. Patients consuming NSAIDS and
steroidal drugs.
5. Duration of surgery less than 1 or more than 4 hours. |
|
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Method of Generating Random Sequence
|
Stratified block randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Incidence and Severity of Post Operative Sore Throat.
|
0,2,6,12,24 hours after Extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence and severity of cough.
2. Incidence and severity of hoarseness of voice. |
0,2,6,12,24 Hours after extubation |
|
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/06/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Different studies have shown that preoperative
nebulization with budesonide in a dose of
400mcg per day is effective for attenuating POST.However, there is
only one study where preoperative nebulisation with fluticasone in a dose of 500mcg was found to be efficacious in
prevention of POST. As Fluticasone is twice as efficacious as Budesonide
[14], we hypothesise that pre-operative nebulization with
250mcg of Fluticasone will be equally effective in reducing the incidence and
severity of POST. In this study we aim to compare the efficacy of
pre-operative nebulisation of 250mcg of
fluticasone with 500mcg fluticasone and normal saline in reduction of
incidence and severity of POST in adult patients following endotracheal intubation under general
anaesthesia. These doses are shown to be not associated with
hypothalamo-pituitary-adrenal axis depression even if
taken for 10 days.
|