Effect of Deep Neuromuscular Block (NMB), Inhalation or TIVA on Pneumoperitoneum.

NCT01930747 | Completed Phase 4 Results

• 1 other identifier: 2013JPM2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the value of deep neuromuscular block (NMB) (using rocuronium) in laparoscopy versus high dose opioids (using remifentanil) or 1 minimum alveolar concentration (MAC) inhalation (using sevoflurane) for the surgeon. The study hypothesis is that laparoscopic workspace is larger when using rocuronium versus opioids or inhalation. Laparoscopic workspace is measured as the abdominal compliance and the pressure at volume zero (PV0) using the abdominal pressure volume relation. Three points allow to calculate the abdominal compliance and the pressure at zero volume (PV0).

Conditions

Muscle Relaxation

Keywords

pneumoperitoneum; laparoscopy

Outcome Measures

Primary Outcomes (2)

• Effect of Anesthetics on the Pressure at Zero Volume (PV0) Measured During Insufflation of the Abdomen

  the impact of the following agents on the pressure at zero volume (PV0): remifentanyl \> 0.50 µg/kg/min; sevoflurane 1 MAC and deep neuromuscular block (rocuronium given with PTC \< 4).

  5 min after reaching 1 MAC or haven given the anesthetics intravenous

• Effect of Anesthetics on the Abdominal Elastance (E) Measured During Insufflation of the Abdomen by

  the impact of the following agents on the abdominal elastance (E) : remifentanyl \> 0.50 µg/kg/min; sevoflurane 1 MAC and deep neuromuscular block (rocuronium given with PTC \< 4).

  5 min after reaching 1 MAC or haven given the anesthetics intravenous

Secondary Outcomes (1)

• Adverse Events Difference Between the Three Groups

  from zero till 24 hours after recovery of surgery.

Study Arms (3)

deep neuromuscular block

EXPERIMENTAL

deep neuromuscular block is given after first measurement of lap workspace one bolus dose of 1 mg/kg rocuronium is given

Drug: rocuronium

inhalation with 1 MAC Sevoflurane

EXPERIMENTAL

1 MAC Sevoflurane inhalation is given after first measurement of lap workspace

Drug: Sevoflurane

remifentanyl

EXPERIMENTAL

remifentanyl infusion is given after first measurement of lap workspace

Drug: remifentanyl

Interventions

rocuronium DRUG

measure effect on laparoscopic workspace

Also known as: esmeron

deep neuromuscular block

Sevoflurane DRUG

1 MAC sevoflurane inhalation is given

Also known as: sevorane

inhalation with 1 MAC Sevoflurane

remifentanyl DRUG

remifentanyl is given in infusion

Also known as: ultiva

remifentanyl

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Laparoscopic bariatric surgery in a patient older than 18 years of age without previous laparotomy. Examples of laparoscopic bariatric procedures are gastric band, sleeve gastrectomy, gastric bypass, gastric bypass after lap band, and revision of a gastric bypass

You may not qualify if:

• Allergies or contraindications to the use of one or more of the following drugs: propofol, rocuronium, sugammadex, remifentanyl, or sevoflurane
• History of a laparotomy
• Emergency laparoscopy

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

Azsintjan

Bruges, 8000, Belgium

Location

MeSH Terms

Conditions

Pneumoperitoneum

Interventions

Rocuronium; Sevoflurane; Remifentanil

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Patients with central obesity were not included in this study patients were it was not possible to measure the abdominal compliance without neuromuscular block were not included in this study

Results Point of Contact

• Title: jan mulier
• Organization: az sint jan brugge

jan.mulier@azsintjan.be

0032486729203

Study Officials

• Jan P Mulier, PhD

  azsintjan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jan Paul J Mulier MD PhD

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: August 29, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: May 29, 2019
• Results First Posted: May 29, 2019

Record last verified: 2019-05

Locations

BE (1)