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临床试验/CTRI/2024/09/073464
CTRI/2024/09/073464尚未招募3 期

Effect of preoperative tramadol gargle on postoperative sore throat in middle ear surgeries under general anaesthesia with endotracheal intubation

NEHA R1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年9月20日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
To study the incidence and severity of sore throat up to 24 hours postoperatively

研究概览

简要总结

This study is designed to study the effect of preoperative Tramadol gargle on postoperative sore throat in patients scheduled for elective middle ear surgeries under general anaesthesia with oral endotracheal intubation. Post-operative sore throat (POAT) is rated to be the 8th most undesirable outcome in the postoperative periodwith an incidence ranging from 14.4-50% after tracheal intubation and 5.8-34% after laryngeal mask airway insertion. The etiology of sore throat is thought to involve mucosal dehydration, trauma from instrumentation and intubation, and mucosal erosion caused by endotracheal tube cuff. Potential risk reduction interventions for POST include smaller sized tube size, limiting intra-cuff pressure, video laryngoscopy, gentle airway instrumentation, extubation after full deflation of cuff, benzydamine hydrochloride, aspirin (NSAIDs), ketamine, magnesium sulphate (NMDA receptor antagonists) and tramadol. Tramadol is a centrally acting analgesic with μ receptor affinity, which inhibits norepinephrine and 5-hydroxytryptamine re-uptake with modulatory effects on voltage gated sodium ion channels, thus exerting a local anaesthetic effect. Tramadol is shown to reduce pain on peritonsillar injection, topical use over tonsillar fossa and to attenuate sore throat when used in gargle form.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient willing to provide informed written consent ASA 1 and 2 Patients undergoing elective middle ear surgery under general anaesthesia Duration of surgery less than 4 hours.

排除标准

  • Patients with history of preoperative sore-throat.
  • History or anticipated difficult intubation.
  • Patients requiring more than one attempt at intubation.
  • History of tramadol/opioid allergy or hypersensitivity.
  • History of asthma, chronic obstructive pulmonary disease.
  • Patient with history of smoking.
  • Patients on steroid therapy.
  • History of seizure disorder.
  • Patients on antidepressants.

结局指标

主要结局

To study the incidence and severity of sore throat up to 24 hours postoperatively

时间窗: To study the incidence and severity at 0, 2, 6, 12, 24 hours postoperatively

次要结局

  • To assess the following at 0, 2h, 6h, 12h and 24h postoperatively:(- Cough)

研究者

发起方
NEHA R
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Neha R

ESICMC AND PGIMSR RAJAJINAGAR BENGALURU

研究点 (1)

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