NCT03913858

Brief Summary

In this study to planned to research the efficacy of low-flow anesthesia on patients undergoing sleeve gastrectomy due to morbid obesity on respiratory functions after surgery by examining FEV1 and FVC values and FEV1/FVC ratio.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2020

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

1.2 years

First QC Date

February 21, 2019

Last Update Submit

July 10, 2020

Conditions

Morbid ObesityAnesthesia ComplicationAnesthesia; Functional

Keywords

Morbid ObesitySleeve GastrectomyLow Flow Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Pulmonary Function Test Results

    FEV1/FVC (%) ratio in hundred morbid obese patients who will undergo laparoscopic sleeve gastrectomy under low flow and high flow anesthesia will be measured

    Preoperative 1st hour and postoperative 24th hours

Secondary Outcomes (1)

  • Length of hospital stay

    Up to 72th hours

Study Arms (2)

high-flow anesthesia

OTHER

Before beginning induction, first 3 mg midazolam and fentanyl 150 mvq IV were administered. According to ideal weight and BIS score for 40-60, 2-5 mg propofol and 0.5 mg rocuronium according to true weight were administered. After intubation 50 mg ranitidine and 8 mg ondansetron were routinely administered. Fixing the remifentanil dose to 0.1 mcg/kg/min, infusion was administered. Group 1 had 4 liter/minute (50% O2, 50% air) flow administered. Mechanical ventilator settings were 6-10 ml tidal volume, frequency 12/min (increasing, if necessary, for etCO2 35-45 mmHg), PEEP 5-10 cm/H2O and inspirium/expirium ratio ½. Both groups had remifentanil ended 10 minutes before the end of surgery. Later 1 g paracetamol and 100 mg tramadol IV were administered.

Procedure: Obesity Surgery with High-Flow Anesthesia

low-flow anesthesia

OTHER

Before beginning induction, first 3 mg midazolam and fentanyl 150 mvq IV were administered. According to ideal weight and BIS score for 40-60, 2-5 mg propofol and 0.5 mg rocuronium according to true weight were administered. After intubation 50 mg ranitidine and 8 mg ondansetron were routinely administered. Fixing the remifentanil dose to 0.1 mcg/kg/min, infusion was administered. Group 2 had 1 liter/minute (50% O2, 50% air) flow administered. Mechanical ventilator settings were 6-10 ml tidal volume, frequency 12/min (increasing, if necessary, for etCO2 35-45 mmHg), PEEP 5-10 cm/H2O and inspirium/expirium ratio ½. Both groups had remifentanil ended 10 minutes before the end of surgery. Later 1 g paracetamol and 100 mg tramadol IV were administered.

Procedure: Obesity Surgery with Low-Flow Anesthesia

Interventions

Obesity Surgery with Low-Flow AnesthesiaPROCEDURE

Group 1 had 1 liter/minute (50% O2, 50% air) flow administered.

Also known as: Procedure/Anesthesia
low-flow anesthesia
Obesity Surgery with High-Flow AnesthesiaPROCEDURE

Group 2 had 4 liter/minute (50% O2, 50% air) flow administered.

Also known as: Procedure/Anesthesia
high-flow anesthesia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • american Society of Anesthesiologists (ASA) III
  • body mass index (BMI) \>40.
  • FEV1/FVC ratio within normal limits
  • FEV1 and FVC values within normal limits
  • those with stop-bang score below 4

You may not qualify if:

  • alcohol abuse
  • drug abuse
  • previous abdominal surgery.
  • chronic obstructive pulmonary disease (COPD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırköy Dr. Sadi Konuk Trainig And Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Evrim Kucur Tulubas, Dr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology and Critical Care Medicine Attending Anaesthesia

Study Record Dates

First Submitted

February 21, 2019

First Posted

April 12, 2019

Study Start

January 10, 2019

Primary Completion

March 10, 2020

Study Completion

April 10, 2020

Last Updated

July 13, 2020

Record last verified: 2020-07

Locations

TU(1)