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临床试验/CTRI/2024/04/066215
CTRI/2024/04/066215尚未招募2/3 期

Comparison of Dexmedetomidine with Mannitol on Intraocular Pressure and Optic Nerve Sheath Diameter changes as a Surrogate Marker of Intracranial Pressure in Laparoscopic Trendelenburg Surgeries : A Randomised Double Blind Controlled Study

Sri Manakula Vinayagar Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年4月30日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
To Compare the Effect of Dexmedetomidine and Mannitol on Intraocular Pressure and Optic Nerve Sheath Diameter in Patients undergoing Laparoscopic Trendelenburg Surgeries

研究概览

简要总结

On the day of surgery patients will be shifted into the operation theatre large bore I.V line access will be secured and Standard ASA monitors will be attached with non-invasive blood pressure (NIBP), electrocardiogram (ECG), heart rate, pulse oximetry. Hemodynamic parameters will be recorded. Baseline values of Optic nerve sheath diameter will be recorded by ultrasonography (by an experienced radiologist) and intraocular pressure will be recorded in supine position using Perkins applanation tonometer (by an experienced ophthalmologist) before general anaesthesia.  Anaesthesia protocol was standardized for drugs used in this procedure, after baseline measurement and adequate preoxygenation with 100% O2 for 3 min, Inj Glycopyrrolate 0.005mg/kg I.V and Inj midazolam 2mg I.V and Inj Fentanyl (2-3mcg/kg) I.V will be administered. Induction with Inj Etomidate 0.2mg-0.3mg/kg I.V , after loss of consciousness patient will be started with Inj Dexmedetomidine 0.5µg/kg loading dose followed by administration of 0.4 µg/kg/hr (in dexmedetomidine group)/ Inj Mannitol 0.5g/kg(in mannitol group) (these two drugs are prepared and kept concealed). Following patient will be given muscle relaxation using Inj atracurium (0.4-0.5mg/kg) I.V and after adequate ventilation for 3 mins Endotracheal  intubation will be performed by an anaesthesiologist and patient will be ventilated in volume control mode with Isoflurane as inhalational agent. During laparoscopic surgery intraperitoneal insufflation of CO2 will be  maintained  around 15mm Hg, IOP & ONSD will be measured 5mins after insufflation CO2 then patient position will be changed into trendelenburg position(>20 degrees from horizontal- measured with IV stand ), IOP and ONSD will be measured 10mins after the patient position changed in TP and measurement of IOP & ONSD will be measured at a time interval of 30mins & 60mins after making the patient in Trendelenburg position, CO2 insufflation will be stopped and evacuated by manual compressions of abdomen by open trocars, patient position will be returned to supine position, IOP and ONSD will be measured before extubation, after discontinuing volatile anaesthetics and patients will be given reversal dose of  Inj Neostigmine 0.05mg-0.08mg/kg, after adequate suction and subsequent attempts of respiration patient will be extubated and patients will be taken up to post-operative ward.

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 75.00 Year(s)(—)
性别
All

入选标准

  • Age 18 to 75 years old American Society of Anaesthesiologists (ASA) physical status I to II Laparoscopic Surgeries in Trendelenburg Position Duration of the Surgery more than 1 hour.

排除标准

  • 未提供

结局指标

主要结局

To Compare the Effect of Dexmedetomidine and Mannitol on Intraocular Pressure and Optic Nerve Sheath Diameter in Patients undergoing Laparoscopic Trendelenburg Surgeries

时间窗: In Supine Position before induction of Anaesthesia (T0) | 10mins after insuffalation of Pneumoperitoneum (T1) | 10mins after making the patient in Trendelenburg position (T2) | 30mins after making the patient in Trendelenburg position (T3) | 1hr after making the patient in Trendelenburg position (T4) | In Supine Position | Before Extubation | (T5)

次要结局

  • 1. To Compare the Hemodynamic Changes in both the groups(2. To Compare the Side effect in both the group the groups)

研究者

发起方
Sri Manakula Vinayagar Medical College and Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Ashwin Kumar

Sri Manakula Vinayagar Medical College and Hospital

研究点 (1)

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