Recruitment Maneuver in General Anesthesia for Laparoscopic Cholecystectomy

NCT06256029 | Recruiting

• 1 other identifier: 00-39/2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective non-randomized clinical trial evaluating the effect of the recruitment maneuver on static compliance in patients undergoing general anesthesia for laparoscopic cholecystectomy

Conditions

Mechanical Ventilation Pressure High

Outcome Measures

Primary Outcomes (1)

• Static compliance

  Cstat = VT / (Pplat - PEEP)

  3 hours

Secondary Outcomes (2)

• Mean arterial pressure

  3 hours

• Arterial blood oxygen level

  3 hours

Study Arms (1)

Experimental group

EXPERIMENTAL

All participants will undergo the recruitment maneuver. The patients will be divided into non-obese patients (BMI 18.5-24.9 kg/m²) and patients with increased body mass (BMI 25-34.9 kg/m²).

Procedure: Recruitment maneuver

Interventions

Recruitment maneuver PROCEDURE

The recruitment maneuver will be performed by increasing the current peak pressure (Ppeak) by 5 cm H2O, changing the inspiratory/expiratory ratio from 1:2 to 1:1, with PEEP values of 5 and 7 cm H2O. The respiratory rate during the recruitment maneuver will be 10 breaths per minute, and the recruitment maneuver will last 30 seconds (5 breaths). The recruitment maneuver will be performed 3 times: the first time immediately after the formation of the pneumoperitoneum and the positioning of the patient in the reverse Trendelenburg position with a PEEP of 5 cm H2O, the second time with a PEEP of 7 cm H2O, during the duration of the operation. The third recruitment maneuver will be performed with a PEEP of 7 cm H2O at the end of the operative procedure, and immediately before the patient wakes up. After each increase, PEEP will be maintained at higher pressure values with a peak value of 7 cm H2O.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients over 18 years of age
• ASA score ≤ 3 (American Society of Anesthesiologists Physical Status)
• scheduled for laparoscopic cholecystectomy

You may not qualify if:

• patients under the age of 18
• pregnant women
• ASA status ˃ 3,
• BMI \< 18.5, and ≥ 35 kg/m2
• previous open abdominal surgery
• previous lung surgery
• obstructive and restrictive lung diseases
• neuromuscular diseases
• hemodynamic instability during recruitment maneuver (drop in systolic blood pressure by more than 20% compared to basal values or systolic blood pressure \< 90 mmHg)
• bradycardia (drop in heart rate by more than 20% or frequency \< 50/min)
• decrease in saturation (SpO2 ≤ 92% for more than 1 minute) during the recruitment maneuver

Sponsors & Collaborators

• University of Novi Sad: lead

Study Sites (1)

Clinical center of Vojvodina

Novi Sad, 21000, Serbia

RECRUITING

Central Study Contacts

Nada Andjelic, MD, PhD

CONTACT

+381214843484; nada.andjelic@mf.uns.ac.rs

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 13, 2024
• Study Start: February 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

SE (1)