Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery

NCT06553066 | Not Yet Recruiting

• 1 other identifier: Bariatric
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuromuscular Blockade

Outcome Measures

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

  During surgery

Secondary Outcomes (17)

• the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography.

  in the first six postoperative hours

• Postoperative pain

  first postoperative day

• Mean arterial pressure (mmHg)

  intraoperative and in Postanesthesia care unit

• PIPcmH20 ( Peak inspiratory pressure)

  intraoperative

• duration of surgery (hr)

  intrapostoperative

Study Arms (2)

Group DNMB ( Deep neuromascular blockage)

EXPERIMENTAL

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; Drug: Moderate neuromascular blockage

Group MNMB ( Moderate neuromascular blockage)

ACTIVE COMPARATOR

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; Drug: Moderate neuromascular blockage

Interventions

Deep neuromascular blockage DRUG

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)

Also known as: Rocuronium and Sugammadex

Group DNMB ( Deep neuromascular blockage); Group MNMB ( Moderate neuromascular blockage)

Moderate neuromascular blockage DRUG

maintenance of a moderate neuromuscular block with rocuronium, titrated to maintain a TOF count of 1-2

Also known as: Rocuronium and Sugammadex

Group DNMB ( Deep neuromascular blockage); Group MNMB ( Moderate neuromascular blockage)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 years ASA II-III who are to undergo planned laparoscopic bariatric surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Patras: lead

MeSH Terms

Interventions

Rocuronium; Sugammadex

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Central Study Contacts

Nikolas Drakos, MD

CONTACT

+306998429336; nikolasdrakos@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: in the assessment of the surgical field quality surgeons are blind respect the level of neuromuscular block received by patients
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: August 14, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share