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

NCT03721536 | Completed

• 1 other identifier: sedatakbas4
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Hemodynamic Instability; Bariatric Surgery Candidate

Keywords

Morbidly obese patients; Bariatric surgery; Arterial blood analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Heart rate

  From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

• Mean arterial pressure

  From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

• Peripheral oxygen saturation

  From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

Study Arms (2)

low-flow anesthesia

ACTIVE COMPARATOR

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.

Diagnostic Test: hemodynamic parameters; Diagnostic Test: arterial blood gase

normal-flow anesthesia

ACTIVE COMPARATOR

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.

Diagnostic Test: hemodynamic parameters; Diagnostic Test: arterial blood gase

Interventions

hemodynamic parameters DIAGNOSTIC_TEST

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

Also known as: heart rate, mean arterial pressure, peripheral oxygen saturation, End-tidal Carbon Dioxide

low-flow anesthesia; normal-flow anesthesia

arterial blood gase 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.

Also known as: partial oxygen pressure, partial carbon dioxide pressure

low-flow anesthesia; normal-flow anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Morbidly obese patients with American Society of Anesthesiology (ASA) scores of III-IV,
• Aged 18-65 years old,
• BMI\>40

You may not qualify if:

• Pregnant
• Uncontrolled diabetes mellitus,
• Cardiovascular disease,
• Pulmonary disease,
• Cerebrovascular disease,
• Drug and alcohol addiction.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Sedat Akbas

Malatya, Türkiye-Türkçe, 44090, Turkey (Türkiye)

Location

Related Publications (1)

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

  BACKGROUND

Related Links

• Low-flow anaesthesia

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Heart Rate; Arterial Pressure; Oxygen Saturation; Blood Gas Analysis; Blood Gas Monitoring, Transcutaneous

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Blood Pressure; Metabolism; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques; Oximetry; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Sedat Akbas, Asst Prof

  Inonu University Medical Faculty

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr. Sedat Akbas

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 26, 2018
• Study Start: October 18, 2018
• Primary Completion: October 30, 2018
• Study Completion: November 1, 2018
• Last Updated: January 7, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)