Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery
- Conditions
- Neuromuscular Blockade
- Interventions
- Drug: Deep neuromascular blockageDrug: Moderate neuromascular blockage
- Registration Number
- NCT06553066
- Lead Sponsor
- University Hospital of Patras
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Patients aged ≥18 years ASA II-III who are to undergo planned laparoscopic bariatric surgery
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group DNMB ( Deep neuromascular blockage) 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) Group DNMB ( Deep neuromascular blockage) Moderate 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) Group MNMB ( Moderate neuromascular blockage) Deep 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) Group MNMB ( Moderate neuromascular blockage) 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)
- Primary Outcome Measures
Name Time Method impact of a deep neuromuscular blockade on surgical conditions 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 Outcome Measures
Name Time Method Mean arterial pressure (mmHg) intraoperative and in Postanesthesia care unit 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
Postoperative nausea and vomiting (PONV) until first postoperative day incidence of PONV
cumulative analgetid dose (mg) until 2 PM the next day of the surgery cumulative analgetid dose until 2 PM the next day of the surgery
PIPcmH20 ( Peak inspiratory pressure) intraoperative 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)
the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography. in the first six postoperative hours quantitatively using chest computed tomography and expressed as percentage to total lung tissue volume
Postoperative pain first postoperative day 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).
Hospitalization time ( days) up to 2 weeks FROM ADMISSION TO HOSPITAL TO DISCHARGE
PEEP cmH20 Intraoperative 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)
duration of surgery (hr) intrapostoperative from the incision to the last skin suture
oxygen saturation (SpO2) % intraoperative and in Postanesthesia care unit 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
DP cmH20( Driving pressure) Intraoperative 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)
The first flatus time (min) up to 5 days the first time that patient flatus postoperative
duration of anesthesia time (min) intraoperative time from anesthesia induction to Extubation
Pplat cmH20 ( plateau pressure), Intraoperative 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)
tidal volume (ml) Intraoperative 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)
dynamic compliance ml/cmH20, Intraoperative 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)
Resistance cmH20/L/sec Intraoperative 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)