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

NCT ID: NCT03721536

Last Updated: 2019-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-18

Study Completion Date

2018-11-01

Brief Summary

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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

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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.

Conditions

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Morbid Obesity Hemodynamic Instability Bariatric Surgery Candidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

hemodynamic parameters

Intervention Type DIAGNOSTIC_TEST

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

arterial blood gase

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

hemodynamic parameters

Intervention Type DIAGNOSTIC_TEST

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

arterial blood gase

Intervention Type 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.

Interventions

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hemodynamic parameters

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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heart rate mean arterial pressure peripheral oxygen saturation End-tidal Carbon Dioxide partial oxygen pressure partial carbon dioxide pressure

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Sedat AKBAS

Asst. Prof. Dr. Sedat Akbas

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sedat Akbas, Asst Prof

Role: STUDY_DIRECTOR

Inonu University Medical Faculty

Locations

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Sedat Akbas

Malatya, Türkiye-Türkçe, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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

Reference Type BACKGROUND

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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sedatakbas4

Identifier Type: -

Identifier Source: org_study_id

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