A Comparative Study Using Dexmedetomidine Continuous Infusion versus TCI-Propofol for Patients Undergoing DISE – A Single-Centre Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Comparision of sedation quality and hemodynamic stability between Dexmedetomidine infusion and TCI Propofol during Drug-Induced Sleep Endoscopy, assessed using BIS Score
研究概览
简要总结
Title:
A comparative study using Dexmedetomidine continuous infusion with TCI-Propofol for patients undergoing Drug-Induced Sleep Endoscopy (DISE) – A single centre prospective randomized controlled trial
Background:
Obstructive sleep apnea (OSA) is a common disorder causing upper airway collapse during sleep, leading to cardiovascular risks and reduced quality of life. DISE is a diagnostic procedure performed under sedation to mimic natural sleep and assess airway obstruction sites to guide surgical treatment.
Objective:
To compare the efficacy and safety of Dexmedetomidine infusion versus Target Controlled Infusion (TCI) with Propofol in obtaining optimal sedation for DISE.
Methods:
Adult patients (18-60 years) with OSA scheduled for DISE were randomized into two groups: Dexmedetomidine infusion and Propofol TCI. Sedation was titrated to a BIS score between 50-70. Primary outcomes included time to achieve sedation without apnea and recovery time. Secondary outcomes were incidences of acute airway collapse and hemodynamic instability.
Study Design:
Randomized, parallel group, active-controlled trial conducted at AIG Hospitals, Hyderabad. Allocation was concealed using sequentially numbered, sealed, opaque envelopes.
Ethical Considerations:
Informed consent was obtained from all participants. The study adhered to ethical principles ensuring patient safety, confidentiality, and rights.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- 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
- •Patients with OSA requiring evaluation of Upper Airway collapse during sleep.
排除标准
- •Patient refusal
- •Age <18yrs or >65yrs
- •ASA status > III
- •Severe Obesity BMI > 40kg/m2
- •Known Allergy to dexmedetomidine or propofol.
结局指标
主要结局
Comparision of sedation quality and hemodynamic stability between Dexmedetomidine infusion and TCI Propofol during Drug-Induced Sleep Endoscopy, assessed using BIS Score
时间窗: 1.Baseline (Pre-sedation) | 2.After achieving the target Sedation | 3.Every 5 minutes during the procedure | 4.Immediate post-procedure
次要结局
- Incidence of acute upper airway collapse requiring airway adjuncts & oxygen support(Observed till 30 minutes post-injection)
研究者
Habeeb Rizwan
AIG Hospitals