"Comparison of of Volume-Controlled Ventilation and Pressure-Controlled Ventilation Modes in Laparoscopic Cholecystectomy"

NCT07709039 | Active Not Recruiting

• 1 other identifier: 18717 / NMU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial compares volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. The study evaluates the effects of both ventilation modes on static lung compliance and end-tidal carbon dioxide (EtCO₂) at predefined intraoperative time points. The objective is to determine whether pressure-controlled ventilation provides improved respiratory mechanics and more effective ventilation compared with volume-controlled ventilation during laparoscopic surgery.

Conditions

Cholelithiases; Laparoscopic Cholecystectomy; General Anaesthesia

Keywords

Volume-Controlled Ventilation; Pressure-Controlled Ventilation; Mechanical Ventilation; Laparoscopic Cholecystectomy; Static Lung Compliance; End-Tidal Carbon Dioxide; Respiratory Mechanics; Pneumoperitoneum; General Anesthesia

Outcome Measures

Primary Outcomes (2)

• Static Lung Compliance

  Comparison of static lung compliance between the volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) groups during elective laparoscopic cholecystectomy under general anesthesia.

  Measured at three intraoperative time points: 5 minutes after induction of anesthesia, 15 minutes after carbon dioxide pneumoperitoneum in the reverse Trendelenburg position, and 10 minutes after carbon dioxide desufflation.

• End-Tidal Carbon Dioxide (EtCO₂)

  Comparison of end-tidal carbon dioxide (EtCO₂) levels between the VCV and PCV groups.

  Measured at three intraoperative time points: 5 minutes after induction of anesthesia, 15 minutes after carbon dioxide pneumoperitoneum in the reverse Trendelenburg position, and 10 minutes after carbon dioxide desufflation.

Secondary Outcomes (1)

• Peak Inspiratory Pressure

  Measured at three intraoperative time points: 5 minutes after induction of anesthesia, 15 minutes after carbon dioxide pneumoperitoneum in the reverse Trendelenburg position, and 10 minutes after carbon dioxide desufflation.

Study Arms (2)

Volume Controlled Ventilation

EXPERIMENTAL

Participants receive volume-controlled ventilation during elective laparoscopic cholecystectomy under general anesthesia.

Procedure: Volume-Controlled Ventilation

Pressure Controlled Ventilation

EXPERIMENTAL

Participants receive pressure-controlled ventilation during elective laparoscopic cholecystectomy under general anesthesia.

Procedure: Pressure Controlled Ventilation

Interventions

Volume-Controlled Ventilation PROCEDURE

Mechanical ventilation delivered using the volume-controlled ventilation mode during elective laparoscopic cholecystectomy under general anesthesia. Ventilation is provided with a tidal volume of 8 mL/kg, respiratory rate adjusted to maintain end-tidal carbon dioxide between 32 and 38 mmHg, PEEP of 5 cmH₂O, FiO₂ of 0.40, and an inspiratory-to-expiratory ratio of 1:2 throughout the surgical procedure.

Volume Controlled Ventilation

Pressure Controlled Ventilation PROCEDURE

Mechanical ventilation delivered using the pressure-controlled ventilation mode during elective laparoscopic cholecystectomy under general anesthesia. Inspiratory pressure is adjusted to achieve a tidal volume of 8 mL/kg while maintaining end-tidal carbon dioxide between 32 and 38 mmHg, with PEEP of 5 cmH₂O, FiO₂ of 0.40, and an inspiratory-to-expiratory ratio of 1:2 throughout the surgical procedure.

Pressure Controlled Ventilation

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aged 25-50 years.
• Either sex.
• ASA physical status I or II.
• Scheduled for elective laparoscopic cholecystectomy under general anaesthesia.
• Written informed consent obtained.

You may not qualify if:

• ASA physical status III or IV.
• Body mass index (BMI) greater than 35 kg/m².
• Significant pulmonary disease (e.g., COPD, asthma, restrictive lung disease).
• Significant cardiovascular disease.
• Pregnancy.
• Previous upper abdominal surgery.
• Conversion to open cholecystectomy.
• Refusal to participate.

Sponsors & Collaborators

• Mehreen Mirza: lead

Study Sites (1)

Nishtar Medical University and Hospital, Multan

Multan, Punjab Province, 00000, Pakistan

Location

MeSH Terms

Conditions

Cholelithiasis; Pneumoperitoneum

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Peritoneal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are unaware of the assigned ventilation mode. Outcome measurements are objective monitor-derived parameters recorded using the anesthesia workstation, minimizing measurement bias. Care providers are not blinded because of the nature of the intervention.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postgraduate Resident, Department of Anaesthesia & Intensive Care, Nishtar Medical University and Hospital, Multan

Model Details: Participants are randomly assigned in a 1:1 ratio to receive either volume-controlled ventilation (VCV) or pressure-controlled ventilation (PCV) during elective laparoscopic cholecystectomy. Respiratory mechanics and end-tidal carbon dioxide are compared between the two parallel groups.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 16, 2026
• Study Start: January 1, 2026
• Primary Completion: June 30, 2026
• Study Completion: July 20, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)