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

Completed

Conditions: 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.

Registration Number: CTRI/2018/04/013426

Lead Sponsor: Dr Vijin Varghese

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)**

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 400

Inclusion Criteria

1. Women of age between 18-70 yrs.
1. American Society of Anaesthesiology Physical Status (ASAPS) grade I-II.
1. Elective surgeries in supine position.

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1): M S Ramaiah Medical College
🇮🇳
Bangalore, KARNATAKA, India
M S Ramaiah Medical College
🇮🇳Bangalore, KARNATAKA, India
Vijin Varghese
Principal investigator
9035977369
drvijin@gmail.com