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

NCT07647770 | Not Yet Recruiting DMC

• 1 other identifier: IRB-2025-01-0913
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Muscle Relaxant Consumption; Mechanical Ventilation; Laparoscopic Cholecystectomy

Keywords

ventilator synchrony, muscle relaxant, laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (2)

• Total intraoperative muscle relaxant consumption

  during the surgery time 1 to 2 hours

• Number of surgeon request to rocuronium top-up doses

  during time of surgery from 1 to two hours

Secondary Outcomes (9)

• Train of four (TOF) ratio

  during time of surgery from 1 to two hours

• Peak airway pressure

  during time of surgery from 1 to two hours

• Compliance

  during time of surgery from 1 to two hours

• Delivered tidal volume

  during time of surgery from 1 to two hours

• Surgeon satisfaction scores (Likert scale: 1-5)

  during time of surgery from 1 to two hours

Study Arms (2)

Non-Synchronized Group (Control)

ACTIVE COMPARATOR

Ventilation managed using PCV-VG mode of ventilation

Other: Non-Synchronized Group (Control)

Synchronized Group

ACTIVE COMPARATOR

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

Other: Synchronized group

Interventions

Non-Synchronized Group (Control) OTHER

Ventilation managed using PCV-VG mode of ventilation

Non-Synchronized Group (Control)

Synchronized group OTHER

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

Synchronized Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-60 years undergoing elective laparoscopic cholecystectomy.
• ASA (American Society of Anesthesiologists) physical status I-II
• BMI 18-35 kg/m²

You may not qualify if:

• Severe COPD or restrictive lung disease
• Neuromuscular disorders
• Emergency surgery
• Morbid obesity

Sponsors & Collaborators

• Hitham Mohammed Aly Elsayed: lead

Study Sites (1)

King Fahd University Hospital

Khobar, Eastern Province, 34445, Saudi Arabia

Location

MeSH Terms

Conditions

Muscle Hypotonia

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Roshdi M Almetwalli, MD

CONTACT

009660138966666; rmetwalli@iau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Anesthesiologists will be divided into three groups; group one (the anesthesiologist who will perform anesthesia and respond to the surgical requests, group two (the anesthesiologist who will design the specific anesthetic plan, and ventilator sitting and the third group (the anesthesiologist who will collect the research data) both group one and three as well as the surgeon are blind to the study design and group assignment. The group two anesthesiologist will leave the room and will not attend the surgery.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: consultant of anesthesia

Model Details: Patients will be randomly allocated into two groups; Non-synchronized group which will be ventilated with pressure controlled volume guaranteed ventilation and Synchronized group which will be ventilated with pressure controlled volume guaranteed plus synchronized mode

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)