Anesthetics and Cerebral Oxygenation in LSG

NCT03946657 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-07-22

No results posted yet for this study

Summary

Obesity is a global health issue that affects different organ systems and may cause severe health issues. Patients with a BMI \> 40 kg/m2 or those with a BMI \> 35 kg/m2 with accompanying comorbidities are candidates for weight loss surgeries, which are generally referred to as bariatric surgeries. Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric surgery procedure gaining increased popularity in the surgical treatment of morbid obesity. However, LSG requires a reverse-Trendelenburg position and prolonged pneumoperitoneum. Carbon dioxide pneumoperitoneum increases intracranial pressure (ICP) by increasing intra-abdominal pressure and by causing dilation of cerebral vessels through carbon dioxide reabsorption. Also, the reverse-Trendelenburg position decreases cardiac output and mean arterial pressure (MAP) by reducing cardiac venous return. A Near-infrared spectroscopy (NIRS) is a non-invasive technique and provides continuous monitoring of regional cerebral tissue oxygen saturation (rSO2).

Sevoflurane and propofol are widely used for the maintenance of general anesthesia during bariatric surgery. Sevoflurane is an efficacious halogenated inhalational anesthetic for bariatric surgery because of its rapid and consistent recovery and because it does not cause hemodynamic instability because of its low blood solubility. Moreover, it increases global CBF through a direct intrinsic cerebral vasodilatory action and, in addition, it might improve cerebral oxygenation by decreasing the cerebral metabolic rate of oxygen (CMRO2) (luxury perfusion). Propofol can also be a suitable option for the maintenance of anesthesia in bariatric surgery. Propofol is a short-acting intravenous anesthetic agent with a very good recovery profile, and its elimination half-life and duration of action do not change in obese individuals. However, it has been reported that propofol may significantly decrease CBF by both suppressing CMRO2 and through a direct vasoconstrictive action. The impact of propofol on global CBF is more salient than that on CMRO2, resulting in a decrease in rSO2. The aim of the present study was to test the hypothesis that rSO2 is better preserved with sevoflurane than propofol in morbidly obese patients who have undergone LSG.

Conditions

  • Morbid Obesity
  • Bariatric Surgery Candidate
  • Anesthesia

Interventions

DRUG

Inhalational anesthetic

Oxygen/air (fraction of inspired oxygen (FiO2) of 0.40), inspiratory fresh gas flow of 2 L/min), sevoflurane (1 minimum alveolar concentration \[MAC\]) and remifentanil IV infusion (0.1-0.25 mcg/kg of LBW/min) were used.Neuromuscular blockade was performed during the operation by rocuronium infusion (0.3-0.7 mg/kg of LBW/h), ensuring that PTC was zero.

DRUG

Intravenous anesthetic

Propofol infusion (4-8 mg/kg of total body weight/h), oxygen/air (FiO2 of 0.40; inspiratory fresh gas flow of 2 L/min) and remifentanil IV infusion (0.1-0.25 μg/kg of LBW/min) were used.Neuromuscular blockade was performed during the operation by rocuronium infusion (0.3-0.7 mg/kg of LBW/h), ensuring that PTC was zero.

Sponsors & Collaborators

  • Ondokuz Mayıs University

    lead OTHER

Principal Investigators

  • CENGIZ KAYA, Assoc. Prof. · Ondokuz Mayis University, School of Medicine, Department of Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-20
Primary Completion
2019-06-01
Completion
2019-06-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03946657 on ClinicalTrials.gov