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临床试验/NCT03079453
NCT03079453已完成4 期

Submucosal Dexamethasone After Tonsillectomy

Bezmialem Vakif University2 个研究点 分布在 2 个国家目标入组 74 人开始时间: 2018年7月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
74
试验地点
2
主要终点
Efficacy of local dexamethasone administration to reduce uvula edema after tonsillectomy evaluated by using the uvula edema scale

研究概览

简要总结

In this prospective controlled study, 74 adults undergoing elective bilateral tonsillectomy for recurrent tonsillitis were consecutively enrolled and sequentially assigned in a 1:1 ratio to receive either local submucosal dexamethasone (8 mg, 1 mL; n = 37) or an equal volume of normal saline (n = 37). The primary outcome was the change in postoperative uvula edema score between postoperative days 1 and 3. Secondary outcomes included postoperative uvula edema grades, pain, dysphagia, speech difficulty, and breathing discomfort assessed on postoperative days 1, 3, and 5.

详细描述

Study Design This study was designed as a prospective, controlled clinical trial conducted at a tertiary referral otorhinolaryngology center. The primary objective was to evaluate whether perioperative local dexamethasone administration accelerates the resolution of uvula edema following tonsillectomy. Secondary objectives included evaluating the relationship between uvula edema severity and patient-reported functional symptoms.

The study protocol was approved by the institutional ethics committee (No. 11/18), and written informed consent was obtained from all participants. The study was conducted in accordance with the Declaration of Helsinki.

Participants Adult patients aged 18-44 years who were scheduled for elective bilateral tonsillectomy due to recurrent tonsillitis were eligible for inclusion. Patients were excluded if they were younger than 18 years; had a diagnosis of obstructive sleep apnea; were scheduled for concomitant surgical procedures; had acute tonsillitis or a peritonsillar abscess at the time of surgery; had received perioperative systemic corticosteroids; or had an American Society of Anesthesiologists (ASA) physical status of III or higher.

Patient Enrollment, Intervention, and Blinding Eligible patients were consecutively enrolled and sequentially assigned in an alternating 1:1 ratio to the dexamethasone (DEX) or control group according to the predefined study protocol. Patients in the DEX group received 8 mg (1 mL) of dexamethasone administered via submucosal injection at three predefined sites around the base of the uvula and adjacent soft palate immediately before tonsillectomy (Figure 1). Patients in the control group received sham injections consisting of an equal volume of normal saline administered at the same anatomical sites. All tonsillectomy procedures were performed under general anesthesia using the bipolar cautery dissection technique by the same two surgeons. No patient received perioperative systemic corticosteroids. Owing to the nature of the intervention, the operating surgeons were aware of group allocation. However, patients and outcome assessors were blinded to treatment assignment. Postoperative assessments were performed independently by two otolaryngologists who were not involved in the surgical procedures.

Outcome Measures The primary outcome was the change in postoperative uvula edema score between postoperative days 1 and 3. This interval was selected to capture the peak inflammatory phase of postoperative uvula edema and to evaluate the early effect of dexamethasone on edema severity.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-44 years Scheduled for elective bilateral tonsillectomy Indication for surgery: recurrent tonsillitis

排除标准

  • Age <18 years Obstructive sleep apnea Concomitant surgical procedures Acute tonsillitis or peritonsillar abscess at the time of surgery Perioperative systemic corticosteroid use ASA physical status III or higher

研究组 & 干预措施

Saline Control

Sham Comparator

Patients in the control group received sham injections consisting of an equal volume of normal saline administered at the same anatomical sites.

干预措施: Normal Saline (Drug)

Submucosal Dexamethasone

Active Comparator

Patients in the DEX group received 8 mg (1 mL) of dexamethasone administered via submucosal injection at three predefined sites around the base of the uvula and adjacent soft palate immediately before tonsillectomy

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Efficacy of local dexamethasone administration to reduce uvula edema after tonsillectomy evaluated by using the uvula edema scale

时间窗: Postoperative first and fifth days

Uvula edema wase evaluated at the postoperative first and fifth days by using the uvula edema scale that the investigators developed.

Change in Uvula Edema Score from Postoperative Day 1 to Day 3

时间窗: Postoperative days 1 to 3

The primary outcome was the change in postoperative uvula edema score between postoperative days 1 and 3.

次要结局

  • Postoperative Uvula Edema Grade(Postoperative days 1, 3, and 5)
  • Postoperative Pain Score(postoperative days 1, 3, and 5.)
  • Postoperative Dysphagia Score(postoperative days 1, 3, and 5.)
  • Postoperative Speech Difficulty Score(postoperative days 1, 3, and 5.)
  • Postoperative Breathing Difficulty Score(postoperative days 1, 3, and 5.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nazan Degirmenci

MD

Bezmialem Vakif University

研究点 (2)

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