Effects of Depth of Neuromuscular Block on Surgical Operating Conditions in Gynecologic Laparoscopic Surgery

NCT03441828 | Completed

• 1 other identifier: Registro MISP n.54876
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of the 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 (Optimal= 5 points/ Good= 4 points / Adequate= 3 points / Poor = 2 points / Inadequate = 1 point) in patients undergoing laparosopy for benign gynecological pathologies.

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 (1)

• the time to discharge from post-anesthesia care unit

  first 12 h post op

Study Arms (2)

Group DNMB

EXPERIMENTAL

Deep Neuromuscular Block group Intervention: maintenance of a deep neuromuscular block by infusion of rocuronium at the starting dose of 0.3-0.6 mg / kg / h, 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 (Optimal= 5 points/ Good= 4 points / Adequate= 3 points / Poor = 2 points / Inadequate = 1 point)

Procedure: Quality of surgical field conditions; Drug: Deep Neuromuscular Block

Group MNMB

ACTIVE COMPARATOR

Moderate Neuromuscular Block group Intervention: maintenance of a moderate neuromuscular block. neuromuscular blockade will be maintained with intravenous bolus of rocuronium (0.15-0.25 mg/kg) titrated to obtain a TOF count of 1-3. Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale (Optimal= 5 points/ Good= 4 points / Adequate= 3 points / Poor = 2 points / Inadequate = 1 point)

Procedure: Quality of surgical field conditions; Drug: Moderate Neuromuscular Block

Interventions

Quality of surgical field conditions PROCEDURE

evaluation of the intraoperative surgical conditions assessed by the surgeon as a 5 points scale (Optimal= 5 points/ Good= 4 points / Adequate= 3 points / Poor = 2 points / Inadequate = 1 point) given by deep vs moderate neuromuscular block

Also known as: surgical field

Group DNMB; Group MNMB

Deep Neuromuscular Block DRUG

maintenance of a deep neuromuscular block by infusion of rocuronium

Also known as: deep relaxation

Group DNMB

Moderate Neuromuscular Block DRUG

maintenance of a moderate neuromuscular block.

Also known as: moderate relaxation

Group MNMB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who give written informed consent to the study
• Age: 18-60 years
• ASA risk class: I - II
• Elective gynecologic laparoscopic surgery lasting \<60 min (excision of ovarian cyst, endometriosis)

You may not qualify if:

• Lack of consent
• Body Mass Index (BMI)\> 30 Kg/m2
• Patients with renal and hepatic dysfunction
• Neuromuscular disorders
• Known hypersensitivity to study drugs
• Pregnant patients
• Conversion to laparotomy

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University Federico II - AOU

Napoli, 80131, Italy

Location

Related Publications (1)

• Coviello A, Ianniello M, Buonanno P, Di Falco N, Iacovazzo C, Maresca A, Vargas M, Marra A, Candice A, Saccone G, Zullo F, Servillo G. Effects of depth of neuromuscular block on surgical operating conditions in women undergoing gynecologic laparoscopic surgery: a randomized clinical trial. J Anesth Analg Crit Care. 2023 Jan 19;3(1):2. doi: 10.1186/s44158-023-00086-7.

  PMID: 37386582 DERIVED

Study Officials

• Edoardo De Robertis, PhD, Prof

  University Federico II

  PRINCIPAL INVESTIGATOR

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: Associate Professor

Model Details: After enrollment, patients will be randomized in the two study groups: Deep Neuromuscular Block group (group DNMB) Moderate Neuromuscular Block group (group MNMB)

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 22, 2018
• Study Start: February 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 31, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)