NCT Number: NCT06553066
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Other names: Rocuronium and Sugammadex
maintenance of a moderate neuromuscular block with rocuronium, titrated to maintain a TOF count of 1-2
Other names: Rocuronium and Sugammadex
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
Time frame: in the first six postoperative hours
quantitatively using chest computed tomography and expressed as percentage to total lung tissue volume
Time frame: 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).
Time frame: 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
Time frame: 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)
Time frame: intrapostoperative
from the incision to the last skin suture
Time frame: up to 5 days
the first time that patient flatus postoperative
Time frame: intraoperative
time from anesthesia induction to Extubation
Time frame: until first postoperative day
incidence of PONV
Time frame: up to 2 weeks
FROM ADMISSION TO HOSPITAL TO DISCHARGE
Time frame: until 2 PM the next day of the surgery
cumulative analgetid dose until 2 PM the next day of the surgery
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Contact information is provided by the study sponsor or research team.
University Hospital of Patras
Other
Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery:
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