Comparative study to see the effects of drug on incidence and severity of post operative sore throat

Not yet recruiting

Conditions: fit and healthy individuals

Registration Number: CTRI/2020/02/023647

Lead Sponsor: Department of anaesthesiology AIIMS Rishikesh

Brief Summary: This study is aimedat assessment of reduction in post-extubation sore throat after administration of study drugs in the cuff of endotracheal tube(ETT) in patients requiring intubation for various surgeries. Dexamethasone in two different doses of 0.1mg/kg,0.2 mg/kg respectively and normal saline will be used as study drugs forinflation of ETT cuff. We will also assess any other complications likehoarseness, dysphonia and airway dysphoria. Other beneficial effects inaddition to reducing airway complications will too be evaluated. The resultscan help us in finding the effectivity of dexamethasone for alleviating POSTand the optimal dose for same. It can further pave way for anaesthetists toconduct studies in patients predisposed to increased airway morbidity likeobese, paediatric, head and neck surgeries, surgeries in prone position etc.

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|**Assessment of POST:**

The assessment of sore throat and hoarseness will be done at one hour, 6 hr and 24 hrs post extubation. Scoring system will be as follows:

POST

0        - no sore throat

1        - Minimal sore throat

2        - Moderate sore throat

3        - Severe sore throat

HOARSENESS

0-      No complaint of hoarseness

1-      Minimal change in quality of speech (minimal hoarseness)

2-      Moderate change in quality of speech (moderate hoarseness)

3-      Gross change in the quality of speech (severe hoarseness)

**Analysis:** Continuous variables will be presented as a mean Â±standard deviation. If the values are unevenly distributed, categoricalvariables will be expressed as frequencies (%). Categorical variables will becompared between the groups using the Chiâ€‘squaretest with the Fisherâ€™s exact test where applicable. Continuous variables willbe compared between the groups using analysis of variance. Postâ€‘hoc analysiswould be performed using the Bonferroni test. Value of p < 0.05 would be considered statistically significant. Theanalysis will be done using Statistical Package for the Social Sciencessoftware, Version 21.0 (IBM Corp., Armonk, NY, USA).

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 75

Inclusion Criteria

1.The population between age group of 18 year to 65 years, weighing 40-80 kg.
2.Patients belonging to ASA I or II.
3.Patients receiving general anaesthesia with endotracheal intubation for elective surgery.

Exclusion Criteria

The study will exclude: 1.Patients with history of recent respiratory tract infection or sore throat.
2.History of neuromuscular disease.
3.Duration of tracheal intubation of < 60 min or > 240 min and requiring more than one attempt for tracheal intubation.
Preoperative use of analgesics or steroids.
History of laryngeal or tracheal surgery or pathology 6.Any patients with diabetes mellitus and obesity will also be excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2- Moderate sore throat	1 h, 6 h, 24 h
Assessment of POST:	1 h, 6 h, 24 h
The assessment of sore throat and hoarseness will be done at one hour, 6 hr and 24 hrs post extubation. Scoring system will be as follows:	1 h, 6 h, 24 h
POST	1 h, 6 h, 24 h
1- Minimal sore throat	1 h, 6 h, 24 h
0- no sore throat	1 h, 6 h, 24 h
3- Severe sore throat	1 h, 6 h, 24 h

Secondary Outcome Measures

Name	Time	Method
HOARSENESS	0-No complaint of hoarseness

Trial Locations

Locations (1): AIIMS
🇮🇳
Garhwal, UTTARANCHAL, India
AIIMS
🇮🇳Garhwal, UTTARANCHAL, India
Bhavna Gupta
Principal investigator
8527686660
bhavna.kakkar@gmail.com