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

Morbid Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03721536
• Other study ID #: sedatakbas4
• Status: Completed
• Phase: N/A
• Start date: October 18, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: January 2019
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 1, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Hemodynamic Instability
• Morbid Obesity
• Obesity, Morbid

Intervention

Diagnostic Test:
• hemodynamic parameters
vital signs on the monitor including heart rate, mean arterial pressure, peripheral oxygen saturation and End-tidal Carbon Dioxide
• 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.

Locations

Country	Name	City	State
Turkey	Sedat Akbas	Malatya	Türkiye-Türkçe

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of partial oxygen pressure	The level of partial oxygen pressure is measured as mmHg in arterial blood gase analysis	From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Secondary	Heart rate	Heart rate is measured as beats/minute on the anesthesia monitor	From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Secondary	Mean arterial pressure	Mean arterial pressure is measured as mmHg on the anesthesia monitor	From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Secondary	Peripheral oxygen saturation	Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor	From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

External Links

•   Low-flow anaesthesia