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临床试验/NCT04211064
NCT04211064Unknown不适用

Comparison Of The Effects Of Deep And Moderate Neuromuscular Blockade On Optic Nerve Sheath Diameter İn Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Bezmialem Vakif University0 个研究点目标入组 60 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
主要终点
Optic nerve sheath diameter

研究概览

简要总结

Increased intracranial pressure (IICP) is a common problem in traumatic brain injuries and many medical diseases. Early recognition of IICP can save lives. Several invasive and non-invasive methods have been described for IICP diagnosis. In recent years, ultrasonographic measurement of optic nerve sheath diameter (ONSD) has become a popular method due to its high sensitivity and specificity for IICP estimation. Studies have shown that ONSD's ultrasonographic measurement correlates with the IICP and can detect intracranial hypertension. The ONSD measurement has advantages such as being easily applied by the clinician at the bedside, being non-invasive, providing immediate results, reproducibility and low cost. It is known that artificial carbon dioxide pneumoperitoneum created in laparoscopic surgeries increases intracranial pressure.However, it is not easy to estimate the degree of changes in ICP during laparoscopic surgery under general anesthesia. In the literature, there are many studies on the sonographic measurement of optic nerve sheath diameter to evaluate the effects of trendelenburg position on intracranial pressure with the use of different anesthetic drugs in laparoscopic surgeries. In addition, there are studies reporting that deep neuromuscular blockade in laparoscopic surgeries increases surgical vision and decreases analgesic requirement in postoperative period. The relationship between neuromuscular block level and intracranial pressure is not clear. From this point of view, the investigators would like to evaluate the effect of moderate and deep neuromuscular block level on intracranial pressure by sonographic measurement of optic nerve sheath diameter in laparoscopic cholecystectomy operations performed with standard pressure artificial carbon dioxide pneumoperitoneum.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Investigator)

盲法说明

The participants were blinded to group allocation, as the measurements were performed after induction of general anesthesia. The investigator measuring the optic nerve sheath diameter was blinded to the group assignment.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Between 18-65 years
  • •Patients undergoing elective laparoscopic cholecystectomy

排除标准

  • •Intracranial hypertension
  • •Chronic obstructive pulmonary disease
  • •Pseudotumor cerebri
  • •Cerebral venous sinus thrombosis
  • •İntraoperative hemodynamic instability
  • •Mean arterial blood pressure<65 mmHg
  • •Body mass index> 35
  • •Kidney or liver problems
  • •Crohn's disease or ulcerative colitis
  • •Previously had any gastrointestinal bleeding
  • •Hypertension
  • •Peripheral arterial disease
  • •Angina, heart attacks, or mild or moderate heart failure

研究组 & 干预措施

Moderate neuromuscular block

Active Comparator

Patients undergoing moderate neuromuscular blockade with rocuronium (TOF 1-3)

干预措施: Moderate neuromuscular block (Procedure)

Deep neuromuscular block

Other

Patients undergoing deep neuromuscular blockade with rocuronium (TOF -- PTC 1-5)

干预措施: Ultrasonographic measurement of optic nerve sheath diameter (Diagnostic Test)

Deep neuromuscular block

Other

Patients undergoing deep neuromuscular blockade with rocuronium (TOF -- PTC 1-5)

干预措施: Deep neuromuscular block (Procedure)

Moderate neuromuscular block

Active Comparator

Patients undergoing moderate neuromuscular blockade with rocuronium (TOF 1-3)

干预措施: Ultrasonographic measurement of optic nerve sheath diameter (Diagnostic Test)

结局指标

主要结局

Optic nerve sheath diameter

时间窗: During surgery

Sonographic optic nerve sheath measurements will be made 5 times, preoperatively, 5 minutes after endotracheal intubation, 5 minutes after pneumoperitoneum, 5 minutes after pneumoperitoneum is terminated and after extubation

次要结局

  • Headache(24 hours)
  • Postoperative nausea and vomiting score(24 hours)
  • Patient satisfaction score(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Serdar Yeşiltaş

Principle Investigator, Medical Doctor, Anesthesiology and Reanimation

Bezmialem Vakif University

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