Impact of Dexmedetomidine Versus Ketamine Soaked Pharyngeal Packing on Postoperative Sore Throat in Functional Endoscopic Sinus Surgery: a Randomized Double Blind Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Incidence of postoperative sore throat (POST)
研究概览
简要总结
The aim of this randomized clinical trial is to evaluate the impact of dexmedetomidine versus ketamine soaked pharyngeal packing on postoperative sore throat in functional endoscopic sinus surgery (FESS).
详细描述
A written informed consent was taken from the patients.patients will be randomly assigned to three groups of 40 subjects each; dexmedetomidine or ketamine or saline soaked pharyngeal packs were situated under direct vision. Throat packs made of gauze with a length of 20 cm and a width of 10 cm (folded transverse four times) and medications were diluted with 20 ml normal saline. The packings were placed by the surgeon blinded to the study groups.
1-Dexmedetomidine group: 75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the posterior pharyngeal wall after induction of anesthesia and & endotracheal tube (ETT).
2-Ketamine group: 50 mg ketamine soaked pharyngeal pack (Group K) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
3-Control group: 20 ml 0.9% saline soaked pharyngeal pack (Group C) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of both sex with American Society of Anesthesiologists (ASA) physical status I-II
- •Elective functional endoscopic sinus surgery (FESS) with endotracheal intubation.
排除标准
- •A history of preoperative sore throat.
- •Upper respiratory tract illness
- •Potentially difficult airway
- •Patients with history of neck, respiratory or digestive tract pathology
- •Chronic smokers
- •Using steroid within the last 48 hour
- •Pregnant women
研究组 & 干预措施
Dexmedetomidine
75 µg dexmedetomidine soaked pharyngeal pack
干预措施: Dexmedetomidine (Drug)
Ketamine
50 mg ketamine soaked pharyngeal pack
干预措施: Ketamine (Drug)
Saline placebo
20 ml 0.9% saline soaked pharyngeal pack
干预措施: saline 0.9% (Other)
结局指标
主要结局
Incidence of postoperative sore throat (POST)
时间窗: 24 hour after surgery
On arrival in the post anesthesia care unit, the patient was immediately evaluated for the presence of sore throat (time 0 hour) using a standardized scale. The severity of POST was graded on a 4-point scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort (complains only with questioning), 2 being moderate sore throat (complains on their own), and 3 being severe sore throat (change in voice, hoarseness, and throat pain). Evaluations occurred at 0, 1, 2, 4, 6, 12 and 24 hours postoperatively.
次要结局
- Postoperative nausea and vomiting (PONV) score(2 hours postoperative)
研究者
Omar Makram Soliman
Lecturer of anesthesia and ICU
Assiut University