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临床试验/CTRI/2024/10/074972
CTRI/2024/10/074972招募中2/3 期

A Comparison between Dexmedetomidine and Remifentanil for rigid Bronchoscopic Pulmonary Procedures A Randomized Controlled Trial

AIIMS, NEW DELHI1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月21日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
The change in hemodynamic variables between

研究概览

简要总结

As a subspecialty of Pulmonary medicine, interventional bronchoscopy has been developing in recent years. Various bronchoscopic procedures include foreign body removal, rigid bronchoscopy, tracheal dilation, Endobronchial ultrasound (EBUS), biopsy of mass etc.

For lung neoplasms, it offers minimally invasive Palliative and therapeutic procedures. In lung cancer cases, the interventional bronchoscopy role has been elevated from “diagnosis priority” to “diagnosis and treatment developed together”. Palliative therapy with bronchoscopy for lung cancer eases dyspnea, relieves airway obstruction, prolongs the survival and improves the quality of life.

Bronchoscopy also plays an important part in the periop period. In the preoperative localization of peripheral pulmonary nodules, the management of tracheoesophageal fistula (TEF)/bronchoesophageal fistula (BEF), and postoperative bronchopleural fistula (BPF), which are complications of lung cancer, Bronchoscopy plays a role.

Rigid bronchoscopy requires some form of anesthesia and various drugs are used for anesthesia. In our study we aim to compare Dexmedetomidine vs remiferntanil with general anesthesia with respect to hemodynamic parameters, postoperative recovery, ponv, cough, and any complications in between the drugs.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Age between 18 to 80 years of age and American Society of Anesthesiologists (ASA) Physical Status Class I, II and III.
  • 2.Patients undergoing rigid bronchoscopic procedures.
  • 3.Patients giving consent for the procedure.

排除标准

  • Severe renal, hepatic or heart failure
  • heart blocks 4.severe obesity
  • allergy to any medications 6.refusal to give consent 7.pregnancy 8.Procedure that takes more than 2 hours.

结局指标

主要结局

The change in hemodynamic variables between

时间窗: Baseline, during rigid bronchoscopy, every 5minutes after that till bronchoscopy is complete. | 5, 10, 15, 30 minutes, 1hour, 2 hours, 4 hours, and 6 hours postop

the groups during rigid bronchoscopy.

时间窗: Baseline, during rigid bronchoscopy, every 5minutes after that till bronchoscopy is complete. | 5, 10, 15, 30 minutes, 1hour, 2 hours, 4 hours, and 6 hours postop

次要结局

  • The time needed for patients to meet(postanesthesia care unit discharge criteria)
  • nausea/vomiting(till 6hrs postop)
  • postop cough(till 6hrs postop)
  • time taken for BIS score to reach 80(till 6hrs postop)
  • Post-op Sore throat(till 6hrs postop)

研究者

发起方
AIIMS, NEW DELHI
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Muralidhara P

All India Institute Of Medical Sciences- New Delhi

研究点 (1)

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