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Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery

U

University Hospital of Patras

Status

Not yet enrolling

Conditions

Neuromuscular Blockade

Treatments

Drug: Moderate neuromascular blockage
Drug: Deep neuromascular blockage

Study type

Interventional

Funder types

Other

Identifiers

NCT06553066
Bariatric

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Group DNMB ( Deep neuromascular blockage)
Experimental group
Description:
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)
Treatment:
Drug: Moderate neuromascular blockage
Drug: Deep neuromascular blockage
Group MNMB ( Moderate neuromascular blockage)
Active Comparator group
Description:
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)
Treatment:
Drug: Moderate neuromascular blockage
Drug: Deep neuromascular blockage

Trial contacts and locations

0

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Central trial contact

Nikolas Drakos, MD

Data sourced from clinicaltrials.gov

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