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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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
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
1 MAC sevoflurane inhalation is given
Other Name: sevorane
remifentanyl infusion is given after first measurement of lap workspace
remifentanyl is given in infusion
Other Name: ultiva
- 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).
- 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).
- 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"
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
|Brugge, Belgium, 8000|
|Principal Investigator:||Jan P Mulier, PhD||azsintjan|