A COMPARATIVE STUDY BETWEEN KETAMINE VERSUS DEXMEDETOMIDINE VERSUS DEXAMETHASONE SOAKED PHARYNGEAL PACKS IN REDUCING POSTOPERATIVE SORE THROAT AFTER HEAD, NECK AND FACE SURGERIES
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- INCIDENCE AND/OR SEVERITY OF POSTOPERATIVE SORE THROAT AMONG THREE DRUGS GROUPS NAMELY KETAMINE, DEXMEDETOMIDINE AND DEXAMETHESONE SOAKED PHARYNGEAL PACKS.
研究概览
简要总结
THIS PROSPECTIVE COMPARATIVE STUDY IS DESIGNED TO COMPARE THE EFFECTIVENESS OF PHARYNGEAL PACKS SOAKED WITH KETAMINE (1ML OF 50MG/ML + 19 ML NORMAL SALINE), DEXMEDETOMIDINE (75 MCG + 20 ML NORMAL SALINE) AND DEXAMETHASONE (8 MG IN 18 ML NORMAL SALINE) AFTER ENDOTRACHEAL INTUBATION AND KEPT THROUGHOUT SURGERY FOLLOWED BY REMOVAL OF PACK BEFORE EXTUBATION, IN REDUCING THE INTENSITY OF POSTOPERATIVE SORE THROAT IN PATIENTS UNDERGOING GENERAL ANESTHESIA.
A TOTAL OF 102 PATIENTS WITH ASA GRADE I OR II, AGED 18-60 YEARS AND MALLAMPATI SCORE 1 OR 2 WILL BE RANDOMLY ASSIGNED TO THREE GROUPS. INTENSITY OF POSTOPERATIVE SORE THROAT WILL BE ASSESSED IMMEDIATELY AFTER EXTUBATION AND THEN 2 HOURS, 4 HOURS, 8 HOURS, 12 HOURS AND 24 HOURS POST EXTUBATION USING STANDARDISED GRADING CRITERIA. HEMODYNAMIC VARIABLES SUCH AS HEART RATE, BLOOD PRESSURE AND ANY DRUG RELATED ADVERSE EVENT WILL ALSO BE MONITORED AND DOCUMENTED.
THIS STUDY IS ANTICIPATED TO DEMONSTRATE THAT ALL THE THREE DRUGS; KETAMINE, DEXMEDETOMIDINE AND DEXAMETHASONE ARE EFFECTIVE IN REDUCING POSTOPERATIVE SORE THROAT WITH EITHER SIMILIAR EFFICACY ORA STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE THREE AGENTS. THE FINDINGS MAY HELP DETERMINE A SAFE AND EFFECTIVE INTERVENTION FOR MINIMIZING POST INTUBATION AIRWAY RELATED 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
- •PATIENTS POSTED FOR HEAD, NECK AND FACE SURGERIES UNDER GENERAL ANESTHESIA WITH ENDOTRACHEAL INTUBATION.
- •PATIENTS WHO ARE CLASSIFIED WITH ASA GRADE I OR II.
- •PATINETS WHO ARE CLASSIFIED WITH MALLAMPATI SCORE 1 OR 2.
排除标准
- •PATIENTS WITH HISTORY OF RECENT AND/OR ACTIVE UPPER RESPIRATORY TRACT ILLNESS.
- •PATIENTS WHO ARE CHRONIC SMOKERS.
- •PATIENTS WITH ANTICIPATED DIFFICULT AIRWAY.
- •PATIENTS WITH HISTORY OF PREOPERATIVE SORE THROAT.
- •PATIENTS WITH KNOWN ALLERGY TO STUDY DRUG.
- •PREOPERATIVE USE OF ANALGESIC DRUGS, LIKE NSAIDS OR OPIOIDS OR STEROIDS.
结局指标
主要结局
INCIDENCE AND/OR SEVERITY OF POSTOPERATIVE SORE THROAT AMONG THREE DRUGS GROUPS NAMELY KETAMINE, DEXMEDETOMIDINE AND DEXAMETHESONE SOAKED PHARYNGEAL PACKS.
时间窗: BASELINE, AFTER INDUCTION, JUST BEFORE INTUBATION, AFTER PHARYNGEAL PACKING, POST EXTUBATION IMMEDIATELY, 2 HOURS, 4 HOURS, 8 HOURS, 12 HOURS, 24 HOURS.
次要结局
- ASSESSING THE PATIENTS FOR INTENSITY OF SORE THROAT, HEMODYNAMIC CHANGES (FOR EXAMPLE: HEART RATE, BLOOD PRESSURE)(BASELINE, AFTER INDUCTION, JUST BEFORE INTUBATION, AFTER PHARYNGEAL PACKING, POST EXTUBATION IMMEDIATELY, 2 HOURS, 4 HOURS, 8 HOURS, 12 HOURS, 24 HOURS.)
研究者
DIVYA SINGH
GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL