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Clinical Trials/NCT04211064
NCT04211064
Unknown
Not Applicable

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 sites60 target enrollmentSeptember 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intracranial Hypertension
Sponsor
Bezmialem Vakif University
Enrollment
60
Primary Endpoint
Optic nerve sheath diameter
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2021
End Date
February 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Serdar Yeşiltaş

Principle Investigator, Medical Doctor, Anesthesiology and Reanimation

Bezmialem Vakif University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Optic nerve sheath diameter

Time Frame: 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

Secondary Outcomes

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

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