Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery
ConditionNeuromuscular Blockade
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Hospital of Patras
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥18 years ASA II-III who are to undergo planned laparoscopic bariatric surgery
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Deep neuromascular blockage
Drugmaintenance 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)
Moderate neuromascular blockage
Drugmaintenance of a moderate neuromuscular block with rocuronium, titrated to maintain a TOF count of 1-2
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Group DNMB ( Deep neuromascular blockage)Experimental treatment 2 interventions
Group B: Group MNMB ( Moderate neuromascular blockage)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
impact of a deep neuromuscular blockade on surgical conditions
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
Time frame
During surgerySecondary outcomes
1
the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography.
quantitatively using chest computed tomography and expressed as percentage to total lung tissue volume
Time frame
in the first six postoperative hours2
Postoperative pain
Pain was measured four times in the PACU (at 15 min intervals starting upon arrival) and twice on the ward (8PM the day of surgery and 2 PM the next day).Pain was measured using an 11-point numerical rating scale (NRS), ranging from 0 (no pain) to 10 (most pain imaginable).
Time frame
first postoperative day3
Mean arterial pressure (mmHg)
measured before induction to general anesthesia, immediately after induction and every 15 min until the end of operation and immediately after awareness.at 15 min intervals starting upon arrival in the post anesthesia care unit
Time frame
intraoperative and in Postanesthesia care unit4
PIPcmH20 ( Peak inspiratory pressure)
Respiratory mechanical parameters were measured after intubation at suspine position, after insufflation of pneumoperitoneum , then the standard different positions of the patient ( Anti-Trendelenburg, supine, anti-trendelenburg and suspine position without premoperitoneum at the end of the procedure)
Time frame
intraoperativeLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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