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Not yet recruiting NCT06553066

Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery

No phase Interventional Neuromuscular Blockade

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep neuromascular blockage, Moderate neuromascular blockage.
Who it may be relevant to
Registry conditions: Neuromuscular Blockade. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery:

Overview

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.

Interventions

  • 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)
  • Drug Moderate neuromascular blockage
    maintenance of a moderate neuromuscular block with rocuronium, titrated to maintain a TOF count of 1-2

Primary outcome measures

  • impact of a deep neuromuscular blockade on surgical conditions [Time frame: During surgery]
Secondary outcome measures (12)
  • the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography. [Time frame: in the first six postoperative hours]
  • Postoperative pain [Time frame: first postoperative day]
  • Mean arterial pressure (mmHg) [Time frame: intraoperative and in Postanesthesia care unit]
  • PIPcmH20 ( Peak inspiratory pressure) [Time frame: intraoperative]
  • duration of surgery (hr) [Time frame: intrapostoperative]
  • The first flatus time (min) [Time frame: up to 5 days]
  • duration of anesthesia time (min) [Time frame: intraoperative]
  • Postoperative nausea and vomiting (PONV) [Time frame: until first postoperative day]
  • Hospitalization time ( days) [Time frame: up to 2 weeks]
  • cumulative analgetid dose (mg) [Time frame: until 2 PM the next day of the surgery]
  • oxygen saturation (SpO2) % [Time frame: intraoperative and in Postanesthesia care unit]
  • tidal volume (ml) [Time frame: Intraoperative]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06553066 · Bariatric

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗