Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Primary Endpoint
- impact of a deep neuromuscular blockade on surgical conditions
Study Overview
Brief Summary
The aim of this study is to investigate the effect of depth of neuromuscular blockade on the surgical field, patient postoperative pain, intestinal motility, the incidence of postoperative nausea and vomiting and the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography.This is a prospective, randomized, controlled clinical-controlled study in patients ≥18 years old scheduled to undergo elective bariatric surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Care Provider)
Masking Description
in the assessment of the surgical field quality surgeons are blind respect the level of neuromuscular block received by patients
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged ≥18 years ASA II-III who are to undergo planned laparoscopic bariatric surgery
Exclusion Criteria
- •ASA 4 patients
- •Maternal population
- •Patients who are not scheduled to receive general anesthesia, but some other type of anesthesia.
- •Contraindicated patients: administration of neuromuscular blockade, suppression of spontaneous respiration, and those with an indication for awake intubation or surgical airway.
- •Patients with neuromuscular diseases
- •Patients who refuse to participate in the study.
Arms & Interventions
Group DNMB ( Deep neuromascular blockage)
Deep Neuromuscular Block group Intervention: maintenance of a deep neuromuscular block with rocuronium, titrated to maintain a TOF count of 0, and a PTC between 1-2.
Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale(Leiden scale : 1 indicates extremely poor conditions, 2 poor conditions, 3 acceptable conditions, 4, good conditions and 5 optimal conditions)
Intervention: Deep neuromascular blockage (Drug)
Group DNMB ( Deep neuromascular blockage)
Deep Neuromuscular Block group Intervention: maintenance of a deep neuromuscular block with rocuronium, titrated to maintain a TOF count of 0, and a PTC between 1-2.
Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale(Leiden scale : 1 indicates extremely poor conditions, 2 poor conditions, 3 acceptable conditions, 4, good conditions and 5 optimal conditions)
Intervention: Moderate neuromascular blockage (Drug)
Group MNMB ( Moderate neuromascular blockage)
Moderate Neuromuscular Block group Intervention: maintenance of a moderate neuromuscular block with rocuronium, titrated to obtain a TOF count of 1-3.
Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale(Leiden scale : 1 indicates extremely poor conditions, 2 poor conditions, 3 acceptable conditions, 4, good conditions and 5 optimal conditions)
Intervention: Deep neuromascular blockage (Drug)
Group MNMB ( Moderate neuromascular blockage)
Moderate Neuromuscular Block group Intervention: maintenance of a moderate neuromuscular block with rocuronium, titrated to obtain a TOF count of 1-3.
Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale(Leiden scale : 1 indicates extremely poor conditions, 2 poor conditions, 3 acceptable conditions, 4, good conditions and 5 optimal conditions)
Intervention: Moderate neuromascular blockage (Drug)
Outcomes
Primary Outcomes
impact of a deep neuromuscular blockade on surgical conditions
Time Frame: During surgery
impact of a deep neuromuscular blockade (TOF count = 0 and posttetanic count \[PTC\] 1-2) and a moderate neuromuscular blockade (TOF count= 1 - 3) on intraoperative surgical conditions assessed by the surgeon as a 5 points scale
Secondary Outcomes
- Mean arterial pressure (mmHg)(intraoperative and in Postanesthesia care unit)
- Postoperative nausea and vomiting (PONV)(until first postoperative day)
- cumulative analgetid dose (mg)(until 2 PM the next day of the surgery)
- PIPcmH20 ( Peak inspiratory pressure)(intraoperative)
- the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography.(in the first six postoperative hours)
- Postoperative pain(first postoperative day)
- Hospitalization time ( days)(up to 2 weeks)
- PEEP cmH20(Intraoperative)
- duration of surgery (hr)(intrapostoperative)
- oxygen saturation (SpO2) %(intraoperative and in Postanesthesia care unit)
- DP cmH20( Driving pressure)(Intraoperative)
- The first flatus time (min)(up to 5 days)
- duration of anesthesia time (min)(intraoperative)
- Pplat cmH20 ( plateau pressure),(Intraoperative)
- tidal volume (ml)(Intraoperative)
- dynamic compliance ml/cmH20,(Intraoperative)
- Resistance cmH20/L/sec(Intraoperative)
Investigators
Nikolas Drakos
MD
University Hospital of Patras