CTRI/2025/05/086221尚未招募不适用
Comparison of clinical performance of LMA BlockBuster and Ambu AuraGain Supraglottic Airways in Laparoscopic Cholecystectomy: A Randomised Controlled Trial
AIIMS Guwahati1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年6月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure.
研究概览
简要总结
This randomized controlled trial compares the clinical performance of LMA BlockBuster® and Ambu® AuraGain™ in patients undergoing laparoscopic cholecystectomy. The primary outcome is oropharyngeal leak pressure (OLP), with secondary outcomes including insertion success, time, fiber-optic view, and postoperative complications. The hypothesis is that BlockBuster® provides a better laryngeal seal and alignment. 160 patients were randomized under standardized general anesthesia.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA physical status I-II
- •Scheduled for elective laparoscopic cholecystectomy.
排除标准
- •BMI more than 35 kg/m²
- •Severe gastroesophageal reflux disease
- •Pregnancy
- •History of upper respiratory tract pathology/surgeries.
结局指标
主要结局
Oropharyngeal leak pressure.
时间窗: N1-0,5,15 MIN | N2-0,5,15,30,45,60,75,90 MIN
次要结局
- Insertion success rate on the first attempt(At SGA insertion time)
- Insertion time(at SGA insertion)
- Device insertion attempts(at SGA Insertion)
- Fiberoptic grade of laryngeal alignment(at SGA Insertion time)
- Hemodynamic changes: HR and MAP(at baseline , immediately after SGA insertion)
- Ventilation parameters (Peak airway pressure, leak fraction)(at 1 min After SGA insertion (T1),5 min Before Carboperitoneum (T2),5 min After Carboperitoneum (T3),5 min Before Removal of Carboperitoneum (T4),5 min After Removal of Carboperitoneum (T5))
- Incidence of postoperative complications(1. Post-operative sore throat (POST))
研究者
Aspari Mahammad Azeez
All India Institute of Medical Sciences,Guwahati
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Phase II Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumour[Substudy 04]NCT07390383Nanjing Leads Biolabs Co.,Ltd110
招募中
2 期
A Phase II Clinical Study of LBL-024 Combination Therapy in Patients With Advanced Solid Tumour[Substudy 03(ESCC)]NCT07331155Nanjing Leads Biolabs Co.,Ltd110
招募中
3 期
LM-108 in Combination With Toripalimab Versus Paclitaxel Injection for the Treatment of Subjects With CCR8-Positive Gastric and Gastroesophageal Junction AdenocarcinomaNCT07362186LaNova Medicines Limited400
尚未招募
不适用
A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in AdultsHearing LossNCT07338864Cochlear66
尚未招募
3 期
Efficacy and Safety of TT-00420 (Tinengotinib) Tablets Versus Chemotherapy in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or MutationsNCT07328919TransThera Sciences (Nanjing), Inc.138