Morbid ObesityNCT03913858
Low Flow Anesthesia in Morbid Obesity
A study testing Obesity Surgery with Low-Flow Anesthesia and Obesity Surgery with High-Flow Anesthesia in people with Morbid Obesity and Anesthesia Complication, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity, Anesthesia Complication, Anesthesia; Functional
- What is being tested?
- Obesity Surgery with Low-Flow Anesthesia and Obesity Surgery with High-Flow Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2019to 10 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- alcohol abuse
- drug abuse
- previous abdominal surgery.
- chronic obstructive pulmonary disease (COPD)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Dr. Sadi Konuk Trainig And Research Hospital
Istanbul
About this study
Official title: Does Low Flow Anesthesia Protect Lung Functions in Laparoscopic Sleeve Gastrectomy?
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.
Read the detailed description
Morbid obese patients undergoing sleeve gastrectomy due to morbid obesity after 01.01.2019 will be randomly divided into 2 groups with controls. To prevent selection bias in the study, numbers will be produced at random. The produced numbers will be determined as 0: control and 1: experiment groups and patients will be divided into groups as such. Random numbers will be generated by the MedCalc 18.2.1. program (MedCalc Statistical Software MedCalc Software bvba, Ostend, Belgium; http://www.medcalc.org; 2018). Group 1 is determined as patients to be administered high-flow anesthesia, while Group 2 will be administered low-flow anesthesia. After anesthesia induction, Group 1 will have 4 liters/minute (50% O2 50%) flow administered, while patients in Group 2 will have 1 liter/minute (50% O2, 50% air) flow administered. The study included adult patients who signed the voluntary consent form aged from 18-65 years, American Society of Anesthesiologists (ASA) III, and body mass index (BMI) >40. Inclusion criteria for the study are no alcohol or drug addiction or diagnosis of chronic obstructive pulmonary disease (COPD) during routine preoperative assessment by chest diseases, FEV1/FVC ratio, FEV1 and FVC values within normal limits and no previous abdominal surgery.
Those with stop-bang score below 4 will be included in the study. On the day of surgery, all patients had FEV1, FVC value and FEV1/FVC ratio examined by a single anesthesia technician using a manual RST device without the knowledge of the anesthesia expert.
Pressure tests and calibration of the anesthesia device is performed each morning for every surgery. After calibration the mechanical ventilator alarm limits for ins O2 are lower limit 40%, EtCO2 35-45 mmHg, min Vol (tidal volume in 1 min x frequency) according to the patient ± 0.5. After patient is placed on the operating table in ramp position, all patients are monitored with triple route ECG, pulse oximetry and pressure cuff. The clinical protocol for all patients undergoing sleeve gastrectomy includes BIS (bispectral index) and TOF (train of four) monitoring. 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. Patients were ventilated with 6 L/min 60% O2 for 2 minutes. Patients were endotracheally intubated with a Macintosh laryngoscope. In addition to assessment of respiratory sounds linked to obesity with auscultation, EtCO2 capnography was used to confirm the efficacy of intubation. 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. Sevoflurane percentage was changed to ensure MAC (minimum alveolar concentration of 0.6-1.1 for BIS score of 40-60 for maintenance. During ventilation in PRVC mode, Group 1 had 4 liter/minute (50% O2, 50% air) flow administered, while Group 2 had 3 L/min 4% for Sevoflurane the first 3 minutes as wash-in. Then flow was administered at 1 L/min (50% O2, 50% air). According to ideal weight, 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. In Group 1, sevoflurane percentage was set to correlate with BIS monitoring. In Group 2, after intubation the sevoflurane percentage was set to a higher percentage to reach the desired MAC value. Every 5 minutes during surgery, MAC, BIS, mean arterial pressure, peak heart rate, sPO2, etCO2, inSO2, frequency and PEEP values were recorded. In Group 2, 5 minutes before the end of surgery, flow was increased from 1 L to 4 L for wash-out. Both groups had remifentanil ended 10 minutes before the end of surgery. Later 1 g paracetamol and 100 mg tramadol IV were administered. Five minutes before the end of the operation patient-controlled SIMV+VE mode with trigger setting of 6 was organized. At the end of surgery, patients were administered 2 mg/kg sugammadex according to ideal weight. When the patients trigger setting reaches muscle power it was lowered to zero. When trigger is zero and there is sufficient tidal volume to reach TOF (train of four) value >90% and BIS score is 80-100, patients were extubated. They were sent to the recovery room. In recovery the ARISCAT risk index was calculated. Later when modified Aldrete scoring system is ≥9, patients were sent to the ward.
After surgery, mobilization and respiratory physiotherapy were provided in the 2nd hour. Vital signs including mean arterial pressure (MAP) were recorded in the postoperative period with 20 mg tenoxicam I.V. administered in the 1st hour. The PCA device was set with tramadol 300 mg/100 ml, bolus 10 mg, lock time 12 minutes without basal infusion. Patients with numeric rating scale (NRS) scores ≥4 had a rescue dose of 4 mg morphine I.V. administered. Each patient began oral intake (water) in the postoperative 24th hour, with early mobilization. A second dose of tenoxicam I.V. was administered in the postoperative 8th hour.
In the 24th hour postoperative, patients had analgesia to ensure VAS score is below 4, with RFT repeated by the same doctor who performed RFT preoperatively.
- Being tested
- Obesity Surgery with Low-Flow Anesthesia, Obesity Surgery with High-Flow Anesthesia
- Keywords
- Morbid Obesity, Sleeve Gastrectomy, Low Flow Anesthesia
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obesity Surgery with Low-Flow AnesthesiaProcedure or surgery
Also called Procedure/Anesthesia
Group 1 had 1 liter/minute (50% O2, 50% air) flow administered.
Obesity Surgery with High-Flow AnesthesiaProcedure or surgery
Also called Procedure/Anesthesia
Group 2 had 4 liter/minute (50% O2, 50% air) flow administered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Obesity Surgery with Low-Flow Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Preoperative 1st hour and postoperative 24th hours
Secondary outcomes (1)
Length of hospital stay
Length of hospital stay (days) of hundred morbid obese patients who will undergo laparoscopic sleeve gastrectomy under low flow and high flow anesthesia will be measured.
Measured: Up to 72th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start10 Jan 2019
- Primary completion10 Mar 2020
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Evrim Kucur Tulubas, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Evrim Kucur Tulubas, Dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913858
- Sponsor's protocol ID
- Obesity Surgery FEV1/FVC
- Other IDs
- Evrim Kucur Tulubas
- Status last verified
- Jul 2020
- First submitted
- 21 Feb 2019
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Low Flow Anesthesia Protect Lung Functions in Laparoscopic Sleeve Gastrectomy?
- ClinicalTrials.gov ID
- NCT03913858
- Acronym / sponsor ID
- Obesity Surgery FEV1/FVC
- Keywords
- Morbid Obesity, Sleeve Gastrectomy, Low Flow Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Morbid obese patients undergoing sleeve gastrectomy due to morbid obesity after 01.01.2019 will be randomly divided into 2 groups with controls. To prevent selection bias in the study, numbers will be produced at random. The produced numbers will be determined as 0: control and 1: experiment groups and patients will be divided into groups as such. Random numbers will be generated by the MedCalc 18.2.1. program (MedCalc Statistical Software MedCalc Software bvba, Ostend, Belgium; http://www.medcalc.org; 2018). Group 1 is determined as patients to be administered high-flow anesthesia, while Group 2 will be administered low-flow anesthesia. After anesthesia induction, Group 1 will have 4 liters/minute (50% O2 50%) flow administered, while patients in Group 2 will have 1 liter/minute (50% O2, 50% air) flow administered. The study included adult patients who signed the voluntary consent form aged from 18-65 years, American Society of Anesthesiologists (ASA) III, and body mass index (BMI) >40. Inclusion criteria for the study are no alcohol or drug addiction or diagnosis of chronic obstructive pulmonary disease (COPD) during routine preoperative assessment by chest diseases, FEV1/FVC ratio, FEV1 and FVC values within normal limits and no previous abdominal surgery.
Those with stop-bang score below 4 will be included in the study. On the day of surgery, all patients had FEV1, FVC value and FEV1/FVC ratio examined by a single anesthesia technician using a manual RST device without the knowledge of the anesthesia expert.
Pressure tests and calibration of the anesthesia device is performed each morning for every surgery. After calibration the mechanical ventilator alarm limits for ins O2 are lower limit 40%, EtCO2 35-45 mmHg, min Vol (tidal volume in 1 min x frequency) according to the patient ± 0.5. After patient is placed on the operating table in ramp position, all patients are monitored with triple route ECG, pulse oximetry and pressure cuff. The clinical protocol for all patients undergoing sleeve gastrectomy includes BIS (bispectral index) and TOF (train of four) monitoring. 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. Patients were ventilated with 6 L/min 60% O2 for 2 minutes. Patients were endotracheally intubated with a Macintosh laryngoscope. In addition to assessment of respiratory sounds linked to obesity with auscultation, EtCO2 capnography was used to confirm the efficacy of intubation. 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. Sevoflurane percentage was changed to ensure MAC (minimum alveolar concentration of 0.6-1.1 for BIS score of 40-60 for maintenance. During ventilation in PRVC mode, Group 1 had 4 liter/minute (50% O2, 50% air) flow administered, while Group 2 had 3 L/min 4% for Sevoflurane the first 3 minutes as wash-in. Then flow was administered at 1 L/min (50% O2, 50% air). According to ideal weight, 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. In Group 1, sevoflurane percentage was set to correlate with BIS monitoring. In Group 2, after intubation the sevoflurane percentage was set to a higher percentage to reach the desired MAC value. Every 5 minutes during surgery, MAC, BIS, mean arterial pressure, peak heart rate, sPO2, etCO2, inSO2, frequency and PEEP values were recorded. In Group 2, 5 minutes before the end of surgery, flow was increased from 1 L to 4 L for wash-out. Both groups had remifentanil ended 10 minutes before the end of surgery. Later 1 g paracetamol and 100 mg tramadol IV were administered. Five minutes before the end of the operation patient-controlled SIMV+VE mode with trigger setting of 6 was organized. At the end of surgery, patients were administered 2 mg/kg sugammadex according to ideal weight. When the patients trigger setting reaches muscle power it was lowered to zero. When trigger is zero and there is sufficient tidal volume to reach TOF (train of four) value >90% and BIS score is 80-100, patients were extubated. They were sent to the recovery room. In recovery the ARISCAT risk index was calculated. Later when modified Aldrete scoring system is ≥9, patients were sent to the ward.
After surgery, mobilization and respiratory physiotherapy were provided in the 2nd hour. Vital signs including mean arterial pressure (MAP) were recorded in the postoperative period with 20 mg tenoxicam I.V. administered in the 1st hour. The PCA device was set with tramadol 300 mg/100 ml, bolus 10 mg, lock time 12 minutes without basal infusion. Patients with numeric rating scale (NRS) scores ≥4 had a rescue dose of 4 mg morphine I.V. administered. Each patient began oral intake (water) in the postoperative 24th hour, with early mobilization. A second dose of tenoxicam I.V. was administered in the postoperative 8th hour.
In the 24th hour postoperative, patients had analgesia to ensure VAS score is below 4, with RFT repeated by the same doctor who performed RFT preoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-flow anesthesia | Other | Procedure: Obesity Surgery with High-Flow AnesthesiaBefore 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. |
| low-flow anesthesia | Other | Procedure: Obesity Surgery with Low-Flow AnesthesiaBefore 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- alcohol abuse
- drug abuse
- previous abdominal surgery.
- chronic obstructive pulmonary disease (COPD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obesity Surgery with Low-Flow AnesthesiaAlso: Procedure/AnesthesiaGroup 1 had 1 liter/minute (50% O2, 50% air) flow administered. | Procedure or surgery | low-flow anesthesia |
| Obesity Surgery with High-Flow AnesthesiaAlso: Procedure/AnesthesiaGroup 2 had 4 liter/minute (50% O2, 50% air) flow administered. | Procedure or surgery | high-flow anesthesia |
Primary outcome
Pulmonary Function Test Results
Time frame: Preoperative 1st hour and postoperative 24th hours
FEV1/FVC (%) ratio in hundred morbid obese patients who will undergo laparoscopic sleeve gastrectomy under low flow and high flow anesthesia will be measured
1 secondary outcome
Length of hospital stay
Time frame: Up to 72th hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evrim Kucur Tulubas, Dr principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obesity Surgery with Low-Flow Anesthesia and Obesity Surgery with High-Flow Anesthesia in people with Morbid Obesity and Anesthesia Complication, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function Test Results (time frame: Preoperative 1st hour and postoperative 24th hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.