Multi-Strategy Intervention for Anesthesia Care of Obese Patients A Factorial Randomized Controlled Trial

NCT05016076 | Withdrawn

• 1 other identifier: JIRB-N202101039
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to investigate the optimal anesthesia for obese patients undergoing bariatric surgery in the strategies of positive pulmonary ventilation, tracheal intubation technique, hemodynamic monitoring, and postoperative nausea and vomiting (PONV) prophylaxis, as the followed:

1. 1.To evaluate the effectiveness and adverse effect of intravenous dexamethasone for PONV prophylaxis
2. 2.To determine the safe inspiratory pressure to prevent the occurrence of gastric insufflation during facemask ventilation using point-of-care ultrasonography of antrum
3. 3.To compare the effectiveness and safety between video intubating stylet and video laryngoscope in the placement of tracheal tubes
4. 4.To apply minimally invasive CO monitors in guiding goal-directed hemodynamic therapy and assess its impact on major complications and postoperative recovery

Conditions

Obesity; Bariatric Surgery Candidate; Tracheal Intubation Morbidity; Nausea and Vomiting, Postoperative; Hyperglycemia Drug Induced; Gastric Reflux

Outcome Measures

Primary Outcomes (4)

• Substudy 1: Number of participants developing postoperative nausea and vomiting

  Primary outcome is postoperative nausea and vomiting, which includes any nausea, emetic episodes (retching or vomiting), or both during the first 24 postoperative hour. At the 2nd and 24th postoperative hours, trained investigators who are blinded to the group allocation will record the number of emetic episodes, the time each one occurs, and self-reported worst nausea episode during the preceding duration on an 11-point scale (0: no nausea and 10: the most severe nausea).

  The first 24 postoperative hour

• Substudy 2: The threshold inspiratory pressure for gastric insufflation

  Primary outcome is the episode of gastric insufflation. The ultrasonographic diagnosis of gastric insufflation is defined as the presence of an acoustic shadow phenomenon and/or a comet-tail artifact into the antrum. A typical whoosh sound with gurgling while auscultating over the epigastrium defines the diagnosis of gastric insufflation by auscultation method.

  Within 2 min after induction of anesthesia

• Substudy 3: The best glottis visualization, graded according to Cormack and Lehane's classification

  Primary outcome is the best glottis visualization, graded according to Cormack and Lehane's classification with external laryngeal pressure applied. The minimum and maximum values of Cormack and Lehane's grade are I and IV, respectively. Glottic views graded as III or IV are regarded as difficult.

  From the induction of anesthesia to the 24th postoperative hours

• Substudy 4: Number of participants developing postoperative major complications

  Primary outcome is a composite of major complications according to the European Perioperative Clinical Outcome definitions within 30 days after surgery, including myocardial ischemia or infarction, arrhythmia, acute kidney injury, gastrointestinal bleeding, anastomotic breakdown, surgical site infection, and hospital-acquired pneumonia. Any events of the above complications will be determined and analyzed aggregately and separately.

  Within 30 days after surgery

Study Arms (11)

Dexamethasone

ACTIVE COMPARATOR

In the designated patients, 8 mg of dexamethasone or placebo will be given intravenously within 10 minutes after the induction of anesthesia. Anesthesia will be maintained with 2-3 vol% sevoflurane and 60% oxygen in nitrogen, whereas the fraction of inspired oxygen (FiO2) 0.8-1.0 will be used during pneumoperitoneum to ensure oxygen saturation higher than 92%.

Drug: Dexamethasone 8 mg

Placebo (0.9% sodium chloride)

PLACEBO COMPARATOR

In the designated patients, 8 mg of dexamethasone or placebo will be given intravenously within 10 minutes after the induction of anesthesia. Anesthesia will be maintained with 2-3 vol% sevoflurane and 60% oxygen in nitrogen, whereas the fraction of inspired oxygen (FiO2) 0.8-1.0 will be used during pneumoperitoneum to ensure oxygen saturation higher than 92%.

Drug: Placebo (0.9% sodium chloride)

Inspiratory pressure (10 cmH2O)

ACTIVE COMPARATOR

After the loss of eyelash reflex, a Guedel oropharyngeal airway (Biçakcilar, Istanbul, Turkey) will be placed into the oral cavity to assure adequate mouth opening. A facemask will be applied firmly to the patient's face to ensure an adequate seal. A two-handed head-tilt jaw-thrust maneuver will be performed to establish an open airway. Once apnea is determined by end-tidal capnography occurs, mechanical ventilation with the assigned peak inspiratory pressure will be initiated. The pressure-controlled mode will be used with an inspiratory-to-expiratory ratio of 1:2 and no positive end-expiratory pressure, at a frequency of 15 breath·min-1 and with 100% oxygen, by the ventilator.

Diagnostic Test: Applied inspiratory pressure (10, 15, 20, or 25 cmH2O)

Inspiratory pressure (15 cmH2O)

ACTIVE COMPARATOR

After the loss of eyelash reflex, a Guedel oropharyngeal airway (Biçakcilar, Istanbul, Turkey) will be placed into the oral cavity to assure adequate mouth opening. A facemask will be applied firmly to the patient's face to ensure an adequate seal. A two-handed head-tilt jaw-thrust maneuver will be performed to establish an open airway. Once apnea is determined by end-tidal capnography occurs, mechanical ventilation with the assigned peak inspiratory pressure will be initiated. The pressure-controlled mode will be used with an inspiratory-to-expiratory ratio of 1:2 and no positive end-expiratory pressure, at a frequency of 15 breath·min-1 and with 100% oxygen, by the ventilator.

Diagnostic Test: Applied inspiratory pressure (10, 15, 20, or 25 cmH2O)

Inspiratory pressure (20 cmH2O)

ACTIVE COMPARATOR

After the loss of eyelash reflex, a Guedel oropharyngeal airway (Biçakcilar, Istanbul, Turkey) will be placed into the oral cavity to assure adequate mouth opening. A facemask will be applied firmly to the patient's face to ensure an adequate seal. A two-handed head-tilt jaw-thrust maneuver will be performed to establish an open airway. Once apnea is determined by end-tidal capnography occurs, mechanical ventilation with the assigned peak inspiratory pressure will be initiated. The pressure-controlled mode will be used with an inspiratory-to-expiratory ratio of 1:2 and no positive end-expiratory pressure, at a frequency of 15 breath·min-1 and with 100% oxygen, by the ventilator.

Diagnostic Test: Applied inspiratory pressure (10, 15, 20, or 25 cmH2O)

Inspiratory pressure (25 cmH2O)

ACTIVE COMPARATOR

After the loss of eyelash reflex, a Guedel oropharyngeal airway (Biçakcilar, Istanbul, Turkey) will be placed into the oral cavity to assure adequate mouth opening. A facemask will be applied firmly to the patient's face to ensure an adequate seal. A two-handed head-tilt jaw-thrust maneuver will be performed to establish an open airway. Once apnea is determined by end-tidal capnography occurs, mechanical ventilation with the assigned peak inspiratory pressure will be initiated. The pressure-controlled mode will be used with an inspiratory-to-expiratory ratio of 1:2 and no positive end-expiratory pressure, at a frequency of 15 breath·min-1 and with 100% oxygen, by the ventilator.

Diagnostic Test: Applied inspiratory pressure (10, 15, 20, or 25 cmH2O)

Video intubating stylet

ACTIVE COMPARATOR

A tracheal tube (ConvaTec, Berkshire, England, UK) in appropriate sizes is preloaded over the Trachway® video intubating stylet (TVI-4050, Markstein Sichtec Medical Corp, Taichung, Taiwan), which is introduced into oral cavity to visualize the epiglottis and guided to glottis via a monitor after full neuromuscular blockade is achieved.

Device: Tracheal intubation using video intubating stylet, video laryngoscopy, or direct laryngoscopy

Video laryngoscopy

ACTIVE COMPARATOR

A tracheal tube is preloaded over a GlideRite® stylet, which is specifically designed to work with GlideScope® video laryngoscope (Verathon Medical, Bothell, WA, USA). GlideScope® blade size 3 (GS-3) or 4 (GS-4) is used in all patients.

Device: Tracheal intubation using video intubating stylet, video laryngoscopy, or direct laryngoscopy

Direct laryngoscopy

ACTIVE COMPARATOR

Tracheal tubes are prepared with a hockey stick-shaped stylet, and direct laryngoscopy is performed using a size-3 or -4 Macintosh blade (Rüsch Inc., Duluth, GA, USA).

Device: Tracheal intubation using video intubating stylet, video laryngoscopy, or direct laryngoscopy

Goal-directed hemodynamic therapy

ACTIVE COMPARATOR

Subjects of the GDHT group will be managed according to the ERAS algorithm utilizing ProAQT® parameters to maintain the cardiac index ≥ 2.5 l·min-1·m-2.61 In brief, if cardiac index \< 2.5 l·min-1·m-2, a bolus of 150 ml of crystalloid fluid will be given until the stroke volume variation is \< 10%. If cardiac index \< 2.5 l·min-1·m-2 despite the stroke volume variation of ≥ 10% following fluid challenge, continuous intravenous infusion of dopamine 5-10 μg·kg-1·min-1 will be administered. If mean arterial pressure is \< 70 mmHg despite cardiac index ≥ 2.5 l·min-1·m-2, intravenous infusion of norepinephrine 2-10 μg·min-1 will be used.

Device: Goal-directed hemodynamic therapy targeting cardiac index

Usual care (control)

NO INTERVENTION

Subjects allocated to the control group are hemodynamically managed as per anesthesiologist preference. Typically, isolated hypotension (20% decrease in mean arterial pressure below baseline or \< 60 mmHg) is treated by single or consecutive boluses of norepinephrine 5 or 10 μg. If hypotension persists, repeat boluses of ephedrine 4 mg will be administered until mean arterial pressure is above 60 mmHg. If hypotension is accompanied by signs of hypovolemia (urine output \< 0.5 ml·kg-1·hr-1 and/or an increase in heart rate \> 20% above baseline), crystalloid or colloid fluids will be given until urine output and/or heart rate are normalized. If hypotension persists despite volume challenge, norepinephrine will be used.

Interventions

Dexamethasone 8 mg DRUG

In the designated patients, 8 mg of dexamethasone or placebo will be given intravenously within 10 minutes after the induction of anesthesia.

Dexamethasone

Applied inspiratory pressure (10, 15, 20, or 25 cmH2O) DIAGNOSTIC_TEST

A two-handed head-tilt jaw-thrust maneuver will be performed to establish an open airway. Once apnea determined by end-tidal capnography occurs, a mechanical ventilation with the assigned peak inspiratory pressure will be initiated. The pressure-controlled mode will be used with an inspiratory-to-expiratory ratio of 1:2 and no positive end-expiratory pressure (PEEP), at a frequency of 15 breath·min-1 and with 100% oxygen, by the ventilator (Carestation 620, Datex-Ohmeda, Inc., Madison, WI, USA).

Inspiratory pressure (10 cmH2O); Inspiratory pressure (15 cmH2O); Inspiratory pressure (20 cmH2O); Inspiratory pressure (25 cmH2O)

Tracheal intubation using video intubating stylet, video laryngoscopy, or direct laryngoscopy DEVICE

In video intubating stylet group, a tracheal tube (ConvaTec, Berkshire, England, UK) in appropriate sizes is preloaded over the Trachway® video intubating stylet (TVI-4050, Markstein Sichtec Medical Corp, Taichung, Taiwan), which is introduced into oral cavity to visualize the epiglottis and guided to glottis via a monitor after full neuromuscular blockade is achieved. In video laryngoscopy group, a tracheal tube is preloaded over a GlideRite® stylet, which is specifically designed to work with GlideScope® video laryngoscope (Verathon Medical, Bothell, WA, USA). GlideScope® blade size 3 (GS-3) or 4 (GS-4) is used in all patients. In direct laryngoscopy group, tracheal tubes are prepared with a hockey stick-shaped stylet, and direct laryngoscopy is performed using a size-3 or -4 Macintosh blade (Rüsch Inc., Duluth, GA, USA).

Direct laryngoscopy; Video intubating stylet; Video laryngoscopy

Goal-directed hemodynamic therapy targeting cardiac index DEVICE

Subjects of the GDHT group will be managed according to the ERAS algorithm utilizing ProAQT® parameters to maintain the cardiac index ≥ 2.5 l·min-1·m-2. In brief, if cardiac index \< 2.5 l·min-1·m-2, a bolus of 150 ml of crystalloid fluid will be given until the stroke volume variation is \< 10%. If cardiac index \< 2.5 l·min-1·m-2 despite the stroke volume variation of ≥ 10% following fluid challenge, continuous intravenous infusion of dopamine 5-10 μg·kg-1·min-1 will be administered. If mean arterial pressure is \< 70 mmHg despite cardiac index ≥ 2.5 l·min-1·m-2, intravenous infusion of norepinephrine 2-10 μg·min-1 will be used.

Goal-directed hemodynamic therapy

Placebo (0.9% sodium chloride) DRUG

Placebo of 0.9% sodium chloride will be given intravenously within 10 minutes after the induction of anesthesia.

Placebo (0.9% sodium chloride)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 20 years
• Body mass index ≥ 30 kg·m-2
• Undergoing laparoscopic sleeve gastrectomy at Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan

You may not qualify if:

• Pregnant or lactating women
• Severe cardiopulmonary distress, including left ventricular ejection fraction \< 40%, double or triple vessel disease, New York Heart Association functional classification ≥ 3, peripheral oxygen saturation by pulse oximetry (SpO2) \< 90% in room air, and moderate to severe pulmonary hypertension.
• Previous esophageal, gastric, or duodenal surgery.
• Previous head and neck surgery or radiation therapy
• Previous cervical spine injury
• High-degree cardiac arrythmia, including atrial fibrillation and severe atrioventricular block
• Use of cardiac pacemaker or automated implantable cardioverter defibrillator
• Chronic kidney disease, stage ≥ 4 (estimated glomerular filtration rate \< 30 ml·min-1)
• Planned transferal to intensive care unit for mechanical ventilation
• QTc prolongation determined by a standard 12-lead electrocardiogram
• Patients using emetogenic or antiemetic drugs within 24 hours before surgery
• Patients requiring rapid sequence induction or fiberoptic awake intubation
• Patient refusal to participate

Sponsors & Collaborators

• YingHsuanTai: lead

Study Sites (1)

Shuang Ho Hospital, Taipei Medical University

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Obesity; Postoperative Nausea and Vomiting; Gastroesophageal Reflux

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ying-Hsuan Tai, M.D.

  Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2021
• First Posted: August 23, 2021
• Study Start: May 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)