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

Not Applicable

Completed

• Conditions: Bariatric Surgery Candidate; Morbid Obesity; Hemodynamic Instability

• Registration Number: NCT03721536
• Lead Sponsor: Inonu University

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.

Study Timeline

• Study Start: 2018-10-18
• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-26
• Primary Completion: 2018-10-30
• Study Completion: 2018-11-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The level of partial oxygen pressure	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

Name	Time	Method
Heart rate	From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)	Heart rate is measured as beats/minute on the anesthesia monitor
Mean arterial pressure	From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)	Mean arterial pressure is measured as mmHg on the anesthesia monitor
Peripheral oxygen saturation	From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)	Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor

Trial Locations

Locations (1)

Sedat Akbas; 🇹🇷 Malatya, Türkiye-Türkçe, Turkey