A clinical trial to study the effects of a drug named dexamethasone in reducing postoperative sore throat after gall bladder removal surgery.

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/06/053773
• Lead Sponsor: DR M SHIVA TEJA

Brief Summary

Postoperative sore throat(POST) is common after endotracheal intubation making the  patients uncomfortable and anxious in post operative period. POST is a common complication after general anaesthesia. Though considered to be a minor complication by most of the clinicians it may be quite distressing for the patient.Post operative sore throat results in cough.Cough after any surgery causes strains at the suture site increasing pain at the  site of surgery and thus further adding to patients discomfort and dissatisfaction.It also adds to patients morbidity and making post operative period a bad memory for the patient. Hoarseness is also known to occur after endotracheal intubation. This change in voice may range from mild hoarseness noted by the patient to complete aphonia.

**PROCEDURE:** After hospital ethical committee approval patients who are satisfying the inclusion criteria will be selected after prior pre-anaesthetic check up.   Patients will be randomly assigned into two equal groups,i.e,GROUP N and GROUP I using computer generated random sequencing software and provided to an assistant in sealed opaque envelopes.

GROUP N: They will receive 2 ml(8 mg) DEXAMETHASONE  nebulisation and 2 ml 0.9 % saline intravenously.

GROUP I: They will receive 2 ml (8 MG) OF i.v DEXAMETHASONE  and nebulisation with 2 ml 0.9 % NACL

The drug volume in both the group will be the same ( nebulisation/intravenous).

Before 30 minutes of commencement of surgery , the patient in group N  will be nebulised with 2 ml of dexamethasone and 2 ml 0.9% NACL given intravenously and viceversa in group I by the assistant.

After the OT patient shifted to PACU where  PR BP RR SPO2  monitored for 24 hours where incidence of POST,PONV,HOARSENESS will be recorded at 1hr,6hr,12hr,24hr postoperatively.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-07
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• 1.ASA classification 1 & 2 2.All genders 3.Patients posted for elective laparoscopic cholecystectomy uder general anaesthesia with endotracheal intubation.
• 4.Duration of surgery less than 2 hours 5.Patients willing to give informed and written consent.

Exclusion Criteria

• 1.history of allergic reactions to DEXAMETHASONE.
• 2.Patients on steroids already.
• 4.Patients who would require manipulation or instrumentation of airway.
• 5.patients who need second attempt during ET tube insertion.
• 6.Patients with sore throat/URTI/hoarseness.
• 7.patients with Cormack Lehane grade 4.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the post operative sore throat (POST) incidence between two groups in first 24 hours	at 1hr,6hr,12hr,24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
1.To compare the incidence of hoarseness & grade of hoarseness between two groups	2.To compare the incidence of postoperative nausea & vomiting (PONV)between two groups

Trial Locations

Locations (1)

GAUHATI MEDICAL COLLEGE AND HOSPITAL,GUWAHATI; 🇮🇳 Kamrup, ASSAM, India

GAUHATI MEDICAL COLLEGE AND HOSPITAL,GUWAHATI

🇮🇳Kamrup, ASSAM, India

DR M SHIVA TEJA

Principal investigator

8374625546

shivateja508@gmail.com