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

Primary Purpose

Morbid Obesity, Hemodynamic Instability, Bariatric Surgery Candidate

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
hemodynamic parameters
arterial blood gase
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Morbid Obesity focused on measuring Morbidly obese patients, Bariatric surgery, Arterial blood analysis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sedat Akbas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

low-flow anesthesia

normal-flow anesthesia

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Heart rate
Heart rate is measured as beats/minute on the anesthesia monitor
Mean arterial pressure
Mean arterial pressure is measured as mmHg on the anesthesia monitor
Peripheral oxygen saturation
Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor

Full Information

First Posted
October 18, 2018
Last Updated
January 4, 2019
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT03721536
Brief Title
Effects of Low-Flow Anesthesia on Hemodynamic Parameters and Oxygenation in Morbidly Obese Patients
Acronym
Oxygenation
Official Title
Effects of Low-Flow Anesthesia on Hemodynamic Parameters and Oxygenation in Morbidly Obese Patients Undergoing Bariatric Surgery: A Prospective, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Hemodynamic Instability, Bariatric Surgery Candidate
Keywords
Morbidly obese patients, Bariatric surgery, Arterial blood analysis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low-flow anesthesia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
normal-flow anesthesia
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
hemodynamic parameters
Other Intervention Name(s)
heart rate, mean arterial pressure, peripheral oxygen saturation, End-tidal Carbon Dioxide
Intervention Description
vital signs on the monitor including heart rate, mean arterial pressure, peripheral oxygen saturation and End-tidal Carbon Dioxide
Intervention Type
Diagnostic Test
Intervention Name(s)
arterial blood gase
Other Intervention Name(s)
partial oxygen pressure, partial carbon dioxide pressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
The level of partial oxygen pressure
Description
The level of partial oxygen pressure is measured as mmHg in arterial blood gase analysis
Time Frame
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Secondary Outcome Measure Information:
Title
Heart rate
Description
Heart rate is measured as beats/minute on the anesthesia monitor
Time Frame
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Title
Mean arterial pressure
Description
Mean arterial pressure is measured as mmHg on the anesthesia monitor
Time Frame
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Title
Peripheral oxygen saturation
Description
Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor
Time Frame
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sedat Akbas, Asst Prof
Organizational Affiliation
Inonu University Medical Faculty
Official's Role
Study Director
Facility Information:
Facility Name
Sedat Akbas
City
Malatya
State/Province
Türkiye-Türkçe
ZIP/Postal Code
44090
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Nunn Geoffrey BA. Low-flow anaesthesia. Continuing Education in Anaesthesia Critical Care & Pain Volume 8, Issue 1, February 2008, Pages 1-4
Results Reference
background
Links:
URL
https://doi.org/10.1093/bjaceaccp/mkm052
Description
Low-flow anaesthesia

Learn more about this trial

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

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