The Impact of Ventilator Synchrony on Muscle Relaxant Consumption and Surgeon Satisfaction During Laparoscopic Cholecystectomy.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHitham Mohammed Aly Elsayed

About this trial

The goal of this clinical trial is to investigate the Impact of adding SIMV Synchronization to our standard PCV-VG mode of ventilation on muscle relaxant consumption, the frequency of relaxant top-ups and surgeon satisfaction during Laparoscopic Cholecystectomy surgeries in ASA I\&II. The main question it aims to answer is do Ventilator synchrony (PCV-VG+SIMV) reduces muscle relaxant consumption and improves surgeon satisfaction by minimizing the perception of inadequate paralysis?

Primary hypothesis: Ventilator synchrony (PCV-VG+SIMV) reduces muscle relaxant consumption and improves surgeon satisfaction by minimizing the perception of inadequate paralysis.

Primary outcome;

1. Compare total intraoperative rocuronium consumption (mg/kg) between PCV-VG and PCV-VG + SIMV 2. To determine the frequency of additional muscle relaxant requests

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-60 years undergoing elective laparoscopic cholecystectomy.

ASA (American Society of Anesthesiologists) physical status I-II

BMI 18-35 kg/m²

Disqualifiers

Severe COPD or restrictive lung disease

Neuromuscular disorders

Emergency surgery

Morbid obesity

Trial design

Design model

Parallel

Treatments tested in this trial

  • Non-Synchronized Group (Control)

    Other intervention

    Ventilation managed using PCV-VG mode of ventilation

  • Synchronized group

    Other intervention

    Ventilation managed using PCV-VG plus SIMV (a mixed mode that supports patient-ventilator synchrony)

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Non-Synchronized Group (Control)Active comparator 1 intervention
Group B: Synchronized GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total intraoperative muscle relaxant consumption

Time frame
during the surgery time 1 to 2 hours
2

Number of surgeon request to rocuronium top-up doses

Time frame
during time of surgery from 1 to two hours

Secondary outcomes

1

Train of four (TOF) ratio

Time frame
during time of surgery from 1 to two hours
2

Peak airway pressure

every 15 minutes

Time frame
during time of surgery from 1 to two hours
3

Compliance

every 15 minutes

Time frame
during time of surgery from 1 to two hours
4

Delivered tidal volume

every 15 minutes

Time frame
during time of surgery from 1 to two hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hitham Mohammed Aly Elsayed

Lead sponsor

Imam Abdulrahman Bin Faisal University

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: