To study the effectiveness of turmeric on prevention of sore throat due to passing of breathing tube into the wind pipe for genral anesthesia by taking turmeric chewable preparation orally and budesonide nebulisation before the operation.

Not yet recruiting

• Conditions: Encounter for prophylactic surgery, unspecified,

• Registration Number: CTRI/2020/06/025706
• Lead Sponsor: DEPARTMENT OF ANAESTHESIOLOGY

Brief Summary

Postoperative sore throat (POST) is the second most common problem found in the postoperative period following tracheal intubation, with literature reporting an incidence of 21-65%. POST occurs mainly by two mechanisms; airway instrumentation causing mucosal injury and irritating effects of a foreign object in the trachea as well as in the upper airway resulting in inflammation.

Budesonide nebulization thought to be effective as it acts on both the upper and lower airway. Though it has not reduced the incidence of POST, it reduces the severity.Lack of local effect on the upper airway may be the reason for this finding. Lozenges used for sore throat reduces the inflammation of the upper airway by acting locally. Magnesium, zinc, strepsils lozenges were found to reduce the incidence of POST.

Studies demonstrated that the turmeric has the following properties: antioxidant, anti-inflammatory, analgesic and anti-microbial, which can possibly reduce incidence of POST. Hence We designed this prospective study to evaluate the effect of preoperative administration of Turmeric lozenges in addition with budesonide nebulization in reducing the incidence and severity of POST in patients undergoing general anaesthesia with endotracheal intubation.

All patients undergoing elective surgical procedures under general anaesthesia with orotracheal intubation at MGMCRI during the study period will form the study population. 100 patients will be selected by continuous sampling after randomization and the lozenges will be kept in sealed envelope according to group allocation by anaesthesia consultant who will not take any further part in the study. In preoperative visit, patients satisfying study criteria will be allocated to one of the study groups (Group B or Group BT). The anaesthesiologist who conducts anaesthesia, blinded to the group allocation, will assess outcome measures in the postoperative period. Neither the outcome assessor nor the patients will know the content of the lozenges, and the code will not be broken until the completion of the study.

All patients will receive General anaesthesia with opioids, induction agents, inhalational anaesthetics, non-depolarizing muscles relaxants, reversal agents and analgesics according to the discretion of the attending anaesthesiologists. Intubation will be done using an Endotracheal tube with standard cuff, with cuff pressure kept at 25cm H2O throughout the surgery. Anaesthesiologists experience in years, CL grading and airway injuries during intubation will be noted. If more than one attempt required for intubation, that patient will be excluded from the study. After standard extubation criteria, patients will be extubated. The incidence of POST will be assessed by asking the presence or absence of soreness in the throat. The severity of POST will be graded on a 4-point scale . The findings will be recorded and analysed.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-05-27
• Study Start: 2020-06-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

2, Age 18-60 years, General anaesthesia with orotracheal intubation.

Exclusion Criteria

History of preoperative URTI or LRTI, History of reactive airway, Pregnant women, Anticipated difficult airway and more than one attempt at intubation, perioperative steroid use and surgeries on the airway including tonsilectomy, neurosurgery, emergency surgeries and surgery lasting more than 4 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Post Operative Sore Throat.	30min, 2, 6 and 24 hours post extubation.

Secondary Outcome Measures

Name	Time	Method
Severity of Post Operative Sore Throat – will be assessed using 4-point scale and Numeric rating scale	4-Point scale:

Trial Locations

Locations (1)

Mahatma Gandhi medical college and research institute; 🇮🇳 Pondicherry, PONDICHERRY, India

Mahatma Gandhi medical college and research institute

🇮🇳Pondicherry, PONDICHERRY, India

R ARUN KUMAR

Principal investigator

8015211292

arunavr6@gmail.com