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

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ClinicalTrials.gov Identifier: NCT01930747
Recruitment Status : Completed
First Posted : August 29, 2013
Results First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Jan Mulier, AZ Sint-Jan AV

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).


Condition or disease Intervention/treatment Phase
Muscle Relaxation Drug: rocuronium Drug: Sevoflurane Drug: remifentanyl Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Deep Neuromuscular Block Versus Inhalation and Total Intravenous Anesthesia (TIVA) on Laparoscopic Surgical Workspace Defined as Insufflated Pneumoperitoneum Volume.
Study Start Date : April 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: deep neuromuscular block
deep neuromuscular block is given after first measurement of lap workspace one bolus dose of 1 mg/kg rocuronium is given
Drug: rocuronium
measure effect on laparoscopic workspace
Other Name: esmeron

Experimental: inhalation with 1 MAC Sevoflurane
1 MAC Sevoflurane inhalation is given after first measurement of lap workspace
Drug: Sevoflurane
1 MAC sevoflurane inhalation is given
Other Name: sevorane

Experimental: remifentanyl
remifentanyl infusion is given after first measurement of lap workspace
Drug: remifentanyl
remifentanyl is given in infusion
Other Name: ultiva




Primary Outcome Measures :
  1. Effect of Anesthetics on the Pressure at Zero Volume (PV0) Measured During Insufflation of the Abdomen [ Time Frame: 5 min after reaching 1 MAC or haven given the anesthetics intravenous ]
    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).

  2. Effect of Anesthetics on the Abdominal Elastance (E) Measured During Insufflation of the Abdomen by [ Time Frame: 5 min after reaching 1 MAC or haven given the anesthetics intravenous ]
    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).


Secondary Outcome Measures :
  1. Adverse Events Difference Between the Three Groups [ Time Frame: from zero till 24 hours after recovery of surgery. ]
    To compare the major adverse events among the patient groups who receive the different agents listed above in the "primary efficacy objective"



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930747


Locations
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Belgium
Azsintjan
Brugge, Belgium, 8000
Sponsors and Collaborators
AZ Sint-Jan AV
Investigators
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Principal Investigator: Jan P Mulier, PhD azsintjan
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Responsible Party: Jan Mulier, Jan Paul J Mulier MD PhD, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT01930747    
Other Study ID Numbers: 2013JPM2
First Posted: August 29, 2013    Key Record Dates
Results First Posted: May 29, 2019
Last Update Posted: May 29, 2019
Last Verified: May 2019
Keywords provided by Jan Mulier, AZ Sint-Jan AV:
pneumoperitoneum
laparoscopy
Additional relevant MeSH terms:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases
Remifentanil
Sevoflurane
Rocuronium
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents