Clinical trial NCT03721536: Effects of Low-Flow Anesthesia on Hemodynamic Parameters and Oxygenation in Morbidly Obese Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Hemodynamic Instability
Bariatric Surgery Candidate
Keywords: Morbidly obese patients
Bariatric surgery
Arterial blood analysis
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: The level of partial oxygen pressure
timeFrame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Secondary outcomes:
measure: Heart rate
timeFrame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
measure: Mean arterial pressure
timeFrame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
measure: Peripheral oxygen saturation
timeFrame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Sedat Akbas
state: Türkiye-Türkçe
Study officials:
affiliation: Inonu University Medical Faculty
name: Sedat Akbas, Asst Prof
role: STUDY_DIRECTOR
References:
citation: Nunn Geoffrey BA. Low-flow anaesthesia. Continuing Education in Anaesthesia Critical Care & Pain Volume 8, Issue 1, February 2008, Pages 1-4