Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery

NCT ID: NCT06553066

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2026-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

Deep neuromascular blockage

Intervention Type: 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)

Moderate neuromascular blockage

Intervention Type: DRUG

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

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)

Group Type: ACTIVE_COMPARATOR

Deep neuromascular blockage

Intervention Type: 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)

Moderate neuromascular blockage

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: DRUG

Moderate neuromascular blockage

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

Intervention Type: DRUG

Other Intervention Names

Rocuronium and Sugammadex; Rocuronium and Sugammadex

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Patras

OTHER

Sponsor Role: lead

Responsible Party

Nikolas Drakos

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nikolas Drakos, MD

Role: CONTACT

nikolasdrakos@hotmail.com

+306998429336

Other Identifiers

Bariatric

Identifier Type: -

Identifier Source: org_study_id