COMPARING THE EFFICACY OF INHALED BUDESONIDE SUSPENSION VERSUS INHALED FLUTICASONE PROPIONATE ADMINISTERED USING A METERED DOSE INHALER, ON POST- OPERATIVE SORE THROAT, HOARSENESS OF VOICE AND COUGH AN OBSERVATIONAL STUDY.”
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- TO COMPARE THE EFFECTIVENESS OF INHALED BUDESONIDE SUSPENSION VERSUS INHALED FLUTICASONE PROPIONATE (ADMINISTERED VIA METERED-DOSE INHALER) IN REDUCING THE INCIDENCE AND SEVERITY OF POST-OPERATIVE SORE THROAT (POST).
研究概览
简要总结
THIS PROSPECTIVE COMPARATIVE STUDY IS DESIGNED TO ASSESS AND COMPARE THE EFFICACY OF INHALED BUDESONIDE SUSPENSION (200 MCG) AND INHALED FLUTICASONE PROPIONATE (150 MCG) DELIVERED VIA A METERED-DOSE INHALER 10 MINUTES PRIOR TO ENDOTRACHEAL INTUBATION, IN REDUCING THE INCIDENCE AND SEVERITY OF POST-OPERATIVE SORE THROAT, COUGH, AND HOARSENESS OF VOICE IN PATIENTS UNDERGOING GENERAL ANAESTHESIA.
A TOTAL OF 104 PATIENTS WITH ASA PHYSICAL STATUS I–II, AGED 18–60 YEARS, WILL BE RANDOMLY ASSIGNED TO TWO GROUPS. POST-OPERATIVE SORE THROAT, COUGH, AND HOARSENESS WILL BE EVALUATED AT 2, 4, 6, 12, AND 24 HOURS FOLLOWING SURGERY USING STANDARDIZED GRADING CRITERIA. HEMODYNAMIC VARIABLES AND ANY DRUG-RELATED ADVERSE EFFECTS WILL ALSO BE MONITORED AND DOCUMENTED.
THE STUDY IS ANTICIPATED TO DEMONSTRATE THAT BOTH INHALED CORTICOSTEROIDS ARE EFFECTIVE IN REDUCING AIRWAY-RELATED POST-OPERATIVE COMPLICATIONS, WITH EITHER SIMILAR EFFICACY OR A STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE TWO AGENTS. THE FINDINGS MAY HELP DETERMINE A SAFE AND EFFECTIVE PROPHYLACTIC INTERVENTION FOR MINIMIZING POST-INTUBATION AIRWAY MORBIDITY.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade I (healthy patients) and II (mild to moderate systemic disease but medically well controlled).
- •Patients posted for elective surgeries in Operation theater.
- •Patients who are MPC 1(complete visualization of uvula)) or 2 (uvula partly visible) as assessed by a senior anesthetist.
排除标准
- •Patients with known allergy to corticosteroid.
- •Patients who are not willing to participate in this study.
- •Patients with pre-existing cardiovascular, renal and hepatic disorders.
- •Patients who have difficult airways as assessed by a senior anesthetist (obese (BMI MORE THAN 30 kg/meter sq), distorted airways.
- •Patients who are anticipated difficult intubation.
- •Patients already on analgesic or steroids (systemic or inhaled).
- •Patients with pre-operative sore throat.
结局指标
主要结局
TO COMPARE THE EFFECTIVENESS OF INHALED BUDESONIDE SUSPENSION VERSUS INHALED FLUTICASONE PROPIONATE (ADMINISTERED VIA METERED-DOSE INHALER) IN REDUCING THE INCIDENCE AND SEVERITY OF POST-OPERATIVE SORE THROAT (POST).
时间窗: ASSESSED AT BASELINE (POST EXTUBATION), 2HOURS, 4 HOURS, 6 HOURS, 12HOURS, AND AT 24 HOURS
次要结局
- TO EVALUATE THE EFFECT OF INHALED BUDESONIDE AND INHALED FLUTICASONE PROPIONATE ON THE HEMODYNAMIC CHANGES(ASSESSED AT BASELINE AFTER INDUCTION, POST INDUCTION, 15 MINUTES, 30 MINUTES, 45 MINUTES, 60 MINUTES, 90 MINUTES,120 MINUTES, BEFORE EXTUBATION, IMMEDIATELY POST EXTUBATION.)
研究者
Rinka Pal
Grant Government Medical college and Sir J J Hospital.