Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery
NCT Number: NCT06553066
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neuromuscular Blockade
Interventions: DRUG: Deep neuromascular blockage|DRUG: Moderate neuromascular blockage
Sponsor: University Hospital of Patras
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2026-08

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.

Primary Outcome Measures: 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, During surgery
Secondary Outcome Measures: 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, in the first six postoperative hours|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)., first postoperative day|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, intraoperative and in Postanesthesia care unit|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), intraoperative|duration of surgery (hr), from the incision to the last skin suture, intrapostoperative|The first flatus time (min), the first time that patient flatus postoperative, up to 5 days|duration of anesthesia time (min), time from anesthesia induction to Extubation, intraoperative|Postoperative nausea and vomiting (PONV), incidence of PONV, until first postoperative day|Hospitalization time ( days), FROM ADMISSION TO HOSPITAL TO DISCHARGE, up to 2 weeks|cumulative analgetid dose (mg), cumulative analgetid dose until 2 PM the next day of the surgery, until 2 PM the next day of the surgery|oxygen saturation (SpO2) %, 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, intraoperative and in Postanesthesia care unit|tidal volume (ml), 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), Intraoperative|Pplat cmH20 ( plateau 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), Intraoperative|dynamic compliance ml/cmH20,, 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), Intraoperative|DP cmH20( Driving 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), Intraoperative|Resistance cmH20/L/sec, 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), Intraoperative|PEEP cmH20, 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), Intraoperative