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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03721536
Recruitment Status : Completed
First Posted : October 26, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Sedat AKBAS, Inonu University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Hemodynamic Instability Bariatric Surgery Candidate Diagnostic Test: hemodynamic parameters Diagnostic Test: arterial blood gase Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Effects of Low-Flow Anesthesia on Hemodynamic Parameters and Oxygenation in Morbidly Obese Patients Undergoing Bariatric Surgery: A Prospective, Randomized Clinical Trial
Actual Study Start Date : October 18, 2018
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: low-flow anesthesia
Patients in low-flow anesthesia receive a fresh gas flow of 4 L/min for the first 10 minutes and were then maintain with a fresh gas flow of 0.75 L/min. Patients will be monitored for hemodynamic parameters during the perioperative period. Arterial blood gase will be analyzed for the oxygenation.
 Diagnostic Test: hemodynamic parameters
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

Diagnostic Test: arterial blood gase
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
Active Comparator: normal-flow anesthesia
Patients in normal-flow anesthesia received a fresh gas flow of 4 L/min for the first 10 minutes and were then maintained with a fresh gas flow of 1.5 L/min. Patients will be monitored for hemodynamic parameters during the perioperative period. Arterial blood gase will be analyzed for the oxygenation.
 Diagnostic Test: hemodynamic parameters
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

Diagnostic Test: arterial blood gase
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721536


Locations
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Turkey
Sedat Akbas
Malatya, Türkiye-Türkçe, Turkey, 44090
Sponsors and Collaborators
Inonu University
Investigators
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Study Director: Sedat Akbas, Asst Prof Inonu University Medical Faculty
  Study Documents (Full-Text)

Documents provided by Sedat AKBAS, Inonu University:
Study Protocol and Statistical Analysis Plan  [PDF] January 18, 2018

More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:
Nunn Geoffrey BA. Low-flow anaesthesia. Continuing Education in Anaesthesia Critical Care & Pain Volume 8, Issue 1, February 2008, Pages 1-4

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Responsible Party: Sedat AKBAS, Asst. Prof. Dr. Sedat Akbas, Inonu University
ClinicalTrials.gov Identifier: NCT03721536    
Other Study ID Numbers: sedatakbas4
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sedat AKBAS, Inonu University:
Morbidly obese patients
Bariatric surgery
Arterial blood analysis
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight