Sore throat after surgery

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/08/044924
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Though Post Operative Sore throat is aminor complication after General Anaesthesia, but it poses immense discomfortto the patient.It leads to cough which may cause strain at the suture siteeventually effects the healing. In this era of day care surgery and enhancedrecovery of the patients after the surgery, patient should be able to return tohis/her routine activity without any discomfort/limitation as early aspossible. Though considered as a minor complication by many clinicians,sorethroat/hoarseness/cough in the post operative period poses high risk of patientdiscomfort and dissatisfaction after the surgery. Total incidence of postoperative sore throat is around 68%.Various pharmacological and nonpharmacological methods were tried with variable success rate.The underlyingcause for POST might be trauma to the oropharynx, base of tongue, or posteriorpharyngeal wall or inflammationsecondary to trauma caused by airway deviceused. Trauma to epithelial layer or deeper layers of vocal cords may initiateinflammation leading to edema. Anti inflammatory drugs will be effective incountering the inflammation caused by the trauma to the airway/ mucosa. Steroidsare one such group of drugs which help in reducing the inflammation caused bythe initial insult/trauma. Hence usage of steroids in various formulations andvarious routes were tried to attenuate the initial inflammation caused due toendo tracheal intubation in the airway mucosa eventually hypothecating thatthere would be reduction in incidence of post operative sore throat.Steroidsreduce the production of inflammatory mediators, prostaglandins, and leukotrienes.The mechanism behind this is inhibition of phospholipase-A2 through productionof calcium-dependent phospholipid-binding proteins known as annex-ins and cyclo-oxygenase.Hence, the efficacy of two highly potent steroids betamethasone and dexamethasonegiven topical and nebulised forms respectively prior to intubationis comparedin reduction of incidence of POST.There is a limited literature available intesting the efficacy of highly potent topical betamethasone preparation when appliedto the Endotracheal tube. So, we attempted to study the efficacy of topicalBetamethasone gel when compared with nebulised dexamethasone in reducing theincidence of post operative sore throat.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-31
• Study Completion: 2023-08-31
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients with ages between 18-60 years ASA Physical Status of 1 & 2 Patients undergoing elective procedures under general anaesthesia with expected surgical duration below 6 hours.

Exclusion Criteria

Pre existing sore throat/ hoarseness on pre op assessment Recent lower respiratory tract infection Known hypersensitivity to steroids Procedure more than 6 hours Oral and neck surgeries Pregnant patients Patients with cognitive disabilities Patients requiring NG tube insertion Patients requiring Rapid Sequence Induction, Intubation Patients requiring use of Succinyl Choline for neuromuscular blockade Difficult intubation Use of additional gadgets such as bougie, stylets for aiding in intubation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sore throat	at 4 hours,8 hours , 12 hours,24 hours and 48 hours after extubation

Secondary Outcome Measures

Name	Time	Method
cough	at 4 hours, 8 hours,12 hours,24 hours,48 hours after extubation

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 Hyderabad, TELANGANA, India

All India Institute of Medical Sciences

🇮🇳Hyderabad, TELANGANA, India

CH RAMA KRISHNA PRASAD

Principal investigator

09885718133

ramakrishna.chikkala19@gmail.com