Effect of supraglottic and subglottic addition of dexamethasone or dexmedetomidine for postoperative sore throat after general anaesthesia

Phase 2/3

Not yet recruiting

• Conditions: Other specified diseases of stomach and duodenum,

• Registration Number: CTRI/2023/03/050517
• Lead Sponsor: SANJAY KUMAR

Brief Summary

After enrolment in the study with the consent of thepatients, they will be assessed preoperatively. All patients will be NPO 8 hrsbefore operation. All thesubjects will be divided into two groups, Group A and Group B in the ratio of1:1 according to random number table. All Patients and anaesthetists will beblinded to group assignments. On bringing the patient to operating room, baseline recording of ECG, SBP, DBP, MBP, HR, RR will be measured using themonitor. The vein channel is to be established during a 18G indwelling needle.A simple face mask will be used for Oxygen for 3 minutes. Then anaesthesia willbe induced through intravenous injection of 2ug/kg Fentanyl, 2mg/kg Propofoland 0.5mg/kg Atracurium/injVecuronium(0.1mg/kg). Afterthree minutes of IPPV, intubation will be performed bydirect laryngoscopy using appropriate size endotracheal tube. A single use highvolume low pressure cuffed ETtube (Tuoren) containing supra & subglotticport for drug instillation will be used for intubation which will be fixed andinflated by 3-5ml of air.After securing ETtube a total volume of 5ml drug (8mgdexamethasone diluted in 3ml normal saline or 100mcg dexmeditomidine diluted in3ml normal sline) will be given in supra & subglottic area through  supra & subglottic port of ET tube(Tuoren).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-03
• Study Start: 2023-10-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

VALID CONSENT , ASA 1 AND 2 , MALLAMPATTI CLASS 1 & 2 , POSTED FOR SURGERY UNDER GENERAL ANAESTHESIA.

Exclusion Criteria

REFUSAL , ASA 3 OR MORE , AGE LESS THAN 18 YRS AND MORE THAN 65 YRS , HISTORY OF UPPER RESPIRATORY TRACT SENSITIVITY AND SORE THROAT , PREGNANCY , MORBID OBESITY , ICU TRANSFERRED PATIENTS WITH E.T TUBE IN SITU.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of supraglottic and subglottic Instillation of dexamethasone verses dexmedetomidine in decreasing the incidence and severity of post operative sore throat (POST) after general anaesthesia.	0, 2 hr, 4 hr, 6 hr, 12 hr, 24 hr

Secondary Outcome Measures

Name	Time	Method
To assess the post operative hemodynamic stability, Pain on deglutition, Hoarseness, Cough or any other adverse effects.	0 , 2 hr , 4 hr , 6 hr , 12 hr , 24 hr

Trial Locations

Locations (1)

IGIMS PATNA; 🇮🇳 Patna, BIHAR, India

IGIMS PATNA

🇮🇳Patna, BIHAR, India

SANJAY KUMAR

Principal investigator

8804709874

sanjay4ujnv@gmail.com