Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery

Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery:

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 Overview

• Status: Not yet recruiting
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Drug: Deep neuromascular blockage; Drug: Moderate neuromascular blockage

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nikolas Drakos, MD; Phone Number: +306998429336; Email: nikolasdrakos@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: Deep neuromascular blockage; 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; Drug: Moderate neuromascular blockage; maintenance of a moderate neuromuscular block with rocuronium, titrated to maintain a TOF count of 1-2; Other Names: Rocuronium and Sugammadex
Active Comparator: 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)	Drug: Deep neuromascular blockage; 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; Drug: Moderate neuromascular blockage; maintenance of a moderate neuromuscular block with rocuronium, titrated to maintain a TOF count of 1-2; Other Names: Rocuronium and Sugammadex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital of Patras

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: August 10, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 10, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: Bariatric

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No