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NCT Number: NCT03721536

Effects of Low-Flow Anesthesia on Hemodynamic Parameters and Oxygenation in Morbidly Obese Patients

Low-flow anesthesia has been used for years with positive results, but its effects on hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese patients who are prone to pulmonary dysfunction related to the obesity. Therefore, this prospective randomized study aimed to compare the effects of low-flow (0.75 L/min) and normal-flow (1.5 L/min) anesthesia on hemodynamic parameters and oxygenation in morbidly obese patients undergoing laparoscopic bariatric surgery.

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Key information

Conditions

Morbid Obesity Bariatric Surgery Candidate Body Weight Hemodynamic Instability Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sedat Akbas

Malatya, Türkiye-Türkçe, 44090, Turkey (Türkiye)

About this study

Low-flow anesthesia has several potential benefits. It improves the flow dynamics of the inhaled air, increase mucociliary clearance, maintain body temperature, reduce fluid loss, result in savings of up to 75% and reduce greenhouse gas emissions and reduce treatment costs (10 - 13). However, it is necessary to examine whether the reduction of fresh gas flow affects the quality and safety of anesthesia management, especially during high-risk operations such as laparoscopic bariatric surgery.

Low-flow anesthesia has been used for years with positive results, but its effects on hemodynamic parameters and oxygenation are not clearly known in high-risk morbidly obese patients who are prone to pulmonary dysfunction related to the obesity. Therefore, this prospective randomized study aimed to compare the effects of low-flow (0.75 L/min) and normal-flow (1.5 L/min) anesthesia on hemodynamic parameters and oxygenation in morbidly obese patients undergoing laparoscopic bariatric surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Morbidly obese patients with American Society of Anesthesiology (ASA) scores of III-IV,
  • Aged 18-65 years old,
  • BMI>40

Exclusion criteria

  • Pregnant
  • Uncontrolled diabetes mellitus,
  • Cardiovascular disease,
  • Pulmonary disease,
  • Cerebrovascular disease,
  • Drug and alcohol addiction.

Treatment and study plan

Hemodynamic parameters

Diagnostic Test

vital signs on the monitor including heart rate, mean arterial pressure, peripheral oxygen saturation and End-tidal Carbon Dioxide

Other names: heart rate, mean arterial pressure, peripheral oxygen saturation, End-tidal Carbon Dioxide

arterial blood gase

Diagnostic Test

Arterial blood gas including partial oxygen pressure and partial carbon dioxide pressure is an important routine investigation to monitor the acid-base balance of patients, effectiveness of gas exchange, and the state of their voluntary respiratory control.

Other names: partial oxygen pressure, partial carbon dioxide pressure

Primary outcomes

  1. The level of partial oxygen pressure

    Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

    The level of partial oxygen pressure is measured as mmHg in arterial blood gase analysis

Secondary outcomes

  1. Heart rate

    Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

    Heart rate is measured as beats/minute on the anesthesia monitor

  2. Mean arterial pressure

    Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

    Mean arterial pressure is measured as mmHg on the anesthesia monitor

  3. Peripheral oxygen saturation

    Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

    Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

Effects of Low-Flow Anesthesia on Hemodynamic Parameters and Oxygenation in Morbidly Obese Patients Undergoing Bariatric Surgery: A Prospective, Randomized Clinical Trial

Acronym: Oxygenation

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 26, 2018
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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