CTRI

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CTRI Number

CTRI/2018/04/013426 [Registered on: 23/04/2018] Trial Registered Retrospectively

Last Modified On:

21/04/2018

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Surgical/Anesthesia

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A Study On The Effect Of Smaller Endotracheal Tube Combined With Intravenous Lignocaine On Post-Operative Sore Throat

Scientific Title of Study

Effect Of Smaller Endotracheal Tube Combined With Intravenous Lignocaine On Post-Operative Sore Throat- A Randomised Controlled Trial.

Trial Acronym

POST (POST OPERATIVE SORE THROAT)

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Vijin Varghese
Designation	Junior resident
Affiliation	M S Ramaiah medical college
Address	Department of Anaesthesiology M S Ramaiah medical college Bangalore Bangalore KARNATAKA 560054 India
Phone	9035977369
Fax
Email	drvijin@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Geetha CR
Designation	Professor
Affiliation	MS Ramaiah medical college
Address	Dept of Anesthesiology M S Ramaiah Medical College MSRIT Post Bangalore Bangalore KARNATAKA 560054 India
Phone	9900482828
Fax
Email	jageedha@yahoo.com

Details of Contact Person
Public Query

Name	Dr Geetha CR
Designation	Professor
Affiliation	MS Ramaiah medical college
Address	Dept of Anesthesiology M S Ramaiah Medical College MSRIT Post Bangalore Bangalore KARNATAKA 560054 India
Phone	9900482828
Fax
Email	jageedha@yahoo.com

Source of Monetary or Material Support

M S Ramaiah Medical College MSRIT Post Bangalore PIN:560054

Primary Sponsor

Name	Dr Vijin Varghese
Address	Senior Resident Dept of Anaesthesiology MOSC MM Medical college Kolenchery Ernakulam District Kerala PIN:682311
Type of Sponsor	Other [self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Vijin Varghese	M S Ramaiah Medical College	Department of Anaesthesiology Bangalore KARNATAKA	9035977369 drvijin@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
M S Ramaiah Medical College And Hospitals Ethical Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	Patients are either free of any medical illness ( American Society Of Anesthesiologists Physical Status i.e ASA PS 1 ) or their systemic diseases well under control (ASA PS 2)prior to the study.,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Endotracheal tube	Comaprison of 7.0 mm and 6.00 mm ETT
Intervention	we are using 2 interventions in 4 groups.The interventions are : 1.Preservative free lignocaine vs saline 2.Size 6.0 mm vs size 7.0 mm cuffed endo-tracheal tube	Patients will be randomly allocated into four groups. The grouping will be as follows: Group A: cuffed ETT size 7.0 with i.v saline. Group B: cuffed ETT size 7.0 with i.v lignocaine. Group C: cuffed ETT size 6.0 with i.v saline. Group D: cuffed ETT size 6.0 with i.v lignocaine. Patients in group B and D will receive 1.5 mg/kg lignocaine intravenously that will be filled in syringe upto10 ml; whereas patients in Group A and C shall receive equal volume of 10ml saline.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Female
Details	1) Women of age between 18-70 yrs. 2) American Society of Anaesthesiology Physical Status (ASAPS) grade I-II. 3) Elective surgeries in supine position

ExclusionCriteria

Details

1) Patients who required more than 2 attempts of intubation.
2) History of pre-operative sore throat or upper respiratory tract infection.
3) Anticipated difficult intubation.
4) Patients with known allergy to lignocaine.
5) Maxillofacial, intra oral and neck surgeries.
6) Surgeries requiring nasogastric tube insertion.
7) American Society of Anaesthesiology Physical Status (ASA PS) grade III and above.
8) Use of succinylcholine during intubation.
9) Smokers.
10) Body mass index (BMI) >30
11) Duration of surgery >5 hours.
12.Patients allergic to diclofenac.

Method of Generating Random Sequence

Random Number Table

Method of Concealment

Pre-numbered or coded identical Containers

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
The overall occurrence and severity of post operative sore throat (POST) at various intervals of time.	The subjects were observed at 1 hour,6 hours and 24 hours after extubation and assessed for the occurrence and severity of post op sore throat.

Secondary Outcome

Outcome	TimePoints
Correlation of age, Mallampati class, intubation attempts, duration of surgery with the occurrence of post operative sore throat.	Final assessment of the secondary outcome will be done 24 hour after observing for post op sore throat.

Target Sample Size

Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "400"
Final Enrollment numbers achieved (India)="400"

Phase of Trial

N/A

Date of First Enrollment (India)

10/11/2014

Date of Study Completion (India)

15/08/2016

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="9"
Days="5"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

Not yet published.

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

Background and Objective: Post operative sore throat (POST) is one of the common complications of general anaesthesia (GA) with endotracheal tube, which may cause patient dissatisfaction after the surgery. Various methods to reduce POST have been tried, both pharmacological and non-pharmacological, with varying results.

The study aims to compare the effectiveness of a combination of intravenous (i.v) lignocaine and smaller endotracheal tube (ETT) on the occurrence and severity of POST.

Methodology: Four hundred women between 18-70 years undergoing elective surgeries under GA with endotracheal tube satisfying the inclusion criteria were allotted into 4 groups:

Group A: cuffed ETT size 7.0 with i.v saline.

Group B: cuffed ETT size 7.0 with i.v lignocaine.

Group C: cuffed ETT size 6.0 with i.v saline.

Group D: cuffed ETT size 6.0 with i.v lignocaine.

After extubation, the patients were assessed for occurrence and severity of sore throat at 1, 6 and 24 hours after surgery.

Results: The incidence and severity of POST were statistically different among the 4 groups.(p<0.001 for overall incidence;p=0.001,p<0.001,p=0.002 for incidence at 1,6,and 24 hours;p=0.027,p=0.030,p=0.622 for different grades of POST at 1 hr,p=0.004,p=0.044 at 6 hrs ,and p=0.008,p=0.622 at 24 hrs respectively.Inter group comparison showed statistical differences in incidence and severity between groups A and C;groups B and D;groups A and D.There was no significant difference in incidence as well as severity of POST when groups A,B and groups C,D were compared.

Conclusion: The use of smaller ETT for GA reduces the incidence as well as severity of POST.Intravenous lignocaine has little effect in preventing the occurrence of POST,but the combination of smaller ETT and i.v lignocaine appears to reduce POST more than when they are used individually.

(P.S: The ethical committee certificate uploaded unfortunately does not contain the title of the thesis as it was provided like that for all the post graduates by the college and it cannot be corrected now.Kindly excuse for the same)