Clinical trial NCT05268900: Ventilation Modes Effect on Intracranial Pressure During Laparoscopic Colectomy by Optic Nerve Sheath Diameter
Official title: Effect of Different Ventilation Modes on Intracranial Pressure During Laparoscopic Colectomy Guided by Optic Nerve Sheath Diameter Measurement.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Colectomy
Keywords: ventilation; intracranial pressure; laparoscopy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 78
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Patients who undergo laparoscopic surgery often experience increased intracranial pressure (ICP). In laparoscopic colectomy surgery, the duration always exceeds 2h with more liability to changes in arterial blood gases, hemodynamics, also the patient is in Trendelenburg position about 30° head down, Trendelenburg position is believed to create changes in hemodynamics, respiratory mechanics, metabolic response, and ICP as it affects vital organs especially if steep positioning. Various modes of mechanical ventilation have been experimented to achieve good intraoperative oxygenation which may cause changes in arterial blood gas values and hemodynamic parameters that might lead to changes in the ICP. In this study we will measure ONSD, basal, intraoperative, and in the PACU to evaluate the effect of different ventilation modes (both VCV mode and PCV-VG mode) on intracranial pressure.

Detailed description: The aim of the current study is to compare the effect of volume control ventilation (VCV) versus pressure control ventilation-volume guaranteed (PCV-VG) as modes of mechanical ventilation on ICP by US guided ONSD measurement during laparoscopic colectomy,

Eligibility criteria: Inclusion Criteria:

* Body mass index less than 30
* American Society of Anesthesiologist physical class I -III.

Exclusion Criteria:

* Patient refusal
* operative time \< 2 hour (h)
* Patients with preexisting eye disease.
* History of eye surgery
* Optic nerve disease.
* Causes of elevated ICP.

Primary outcomes:
measure: Changes in ONSD O(optic) N(nerve) S(sheath) D(diameter)
timeFrame: Changes from baseline, till 30 minutes after recovery from anaesthesia
Secondary outcomes:
measure: Heart rate
timeFrame: Changes from baseline, till 30 minutes after recovery from anaesthesia
measure: Mean arterial blood pressure
timeFrame: Changes from baseline, till 30 minutes after recovery from anaesthesia
measure: Peak airway pressure
timeFrame: intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).
measure: Plateau airway pressure
timeFrame: intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).
measure: mean airway pressure
timeFrame: intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).
measure: Dynamic Lung compliance
timeFrame: intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).
measure: Static Lung compliance
timeFrame: intra-operative changes from (post induction) just after induction of anesthesia and intubation, till the end of surgery (before extubation).
measure: pH
timeFrame: Changes from baseline, till 30 min after recovery from anesthesia.
measure: PaCO2 (carbon dioxide tension)
timeFrame: Changes from baseline, till 30 min after recovery from anesthesia.
measure: Headache
timeFrame: for 24 hour after surgery
measure: Postoperative nausea and vomiting
timeFrame: for 24 hour after surgery
measure: PaO2 (partial pressure of arterial oxygen)
timeFrame: Changes from baseline, till 30 min after recovery from anesthesia
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Assistant professor, MD anesthesia Department, Faculty of Medicine,
name: Hanaa M El Bendary
role: STUDY_DIRECTOR
affiliation: professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
name: Doaa G Diab
role: STUDY_CHAIR
References: