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临床试验/CTRI/2025/09/094916
CTRI/2025/09/094916尚未招募1 期

Comparison of video laryngoscope with direct laryngoscope for the effect of laryngoscopy and intubation on optic nerve sheath diameter in adult patients undergoing laparoscopic cholecystectomy

Santhosh Kumar A1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
1. Optic nerve sheath diameter

研究概览

简要总结

To compare video laryngoscope with direct laryngoscope for the effect of laryngoscopy and intubation on optic nerve sheath diameter in adult patients undergoing laparoscopic cholecystectomy.

Primary objective: To compare C-MAC video laryngoscope with direct laryngoscope for the effect on Optic Nerve Sheath Diameter (ONSD) measured by trans ocular ultrasound at 1,3 and 5 minutes after laryngoscopy and intubation in adult patients undergoing laparoscopic cholecystectomy

Secondary objectives:

A. To compare C-MAC video laryngoscope with direct laryngoscope for the effect on Heart Rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP) & Mean arterial pressure (MAP) at 1,3 &5 minutes post laryngoscopy and intubation.

B. To measure optic nerve sheath diameter (ONSD) by trans ocular ultrasound, Heart Rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP) & Mean arterial pressure (MAP) at 1. 10 & 60 minutes after insufflation of pneumoperitoneum 2. 10 minutes after desufflation of pneumoperitoneum in supine position.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator 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

  • ASA 1 and ASA 2 patients undergoing laparoscopic cholecystectomy.

排除标准

  • Patients with anticipated difficult airway, neurological conditions, patients with history of eye infections and diabetic retinopathy, history of intracranial or intraocular surgery.

结局指标

主要结局

1. Optic nerve sheath diameter

时间窗: 1. At baseline | 2. 1,3 & 5 minutes after intubation | 3. 10 and 60 minutes after insufflation of pneumoperitoneum | 4.10 minutes after desufflation of pneumoperitoneum

次要结局

  • 1. Systolic Blood Pressure(2. Diastolic Blood Pressure)

研究者

发起方
Santhosh Kumar A
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Santhosh Kumar A

Vardhman Mahavir Medical College and Safdarjung Hospital

研究点 (1)

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