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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04076709
Other study ID # P19.042
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date September 1, 2020
Est. completion date September 1, 2021

Study information

Verified date June 2020
Source Leiden University Medical Center
Contact Martijn Boon, MD PhD
Phone +31 71-5262301
Email m.boon@lumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Many surgical procedures are performed using the laparoscopic approach. However, insufflation of the abdomen (pneumoperitoneum) has detrimental hemodynamic effects. The investigators intend to investigate the effect of deep neuromuscular block and nociception guided anaesthesia on hemodynamic variables during pneumoperitoneum for lower abdominal laparoscopic surgery.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

ASA 1-3;

- Scheduled for lower laparoscopic abdominal surgery;

- Ability to give oral and written consent;

Exclusion Criteria:

- Known or suspected neuromuscular disorders impairing neuromuscular function;

- Allergies to muscle relaxants, anesthetics or narcotics;

- A (family) history of malignant hyperthermia;

- Women who are or may be pregnant;

- Preexisting cardiac disease (any);

- Untreated or uncontrolled hypertension;

- COPD gold 3 or higher

- Preexistent esophageal pathology (stricture, tumor, diverticulum)

- Any increased risk factor for upper gastro intestinal tract bleed:

- History of GI surgery;

- History of GI bleed;

- Esophageal varices;

- Gastric or esophageal inflammation;

- Severe thrombocytopenia (less than 50k) or severely elevated INR (>4).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
goal directed anaesthesia
Deep neuromuscular blockade (PTC 1-2) Nociception level index (NOL) target 10-25

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Leiden University Medical Center

Outcome

Type Measure Description Time frame Safety issue
Other Ejection fraction Left ventricular ejection fraction measured by TEE 5 minutes after installation of pneumoperitoneum
Other Ejection fraction Left ventricular ejection fraction measured by TEE 30 minutes after installation of pneumoperitoneum
Other Ejection fraction Left ventricular ejection fraction measured by TEE 60 minutes after installation of pneumoperitoneum
Primary Blood pressure Mean arterial pressure 30 minutes after installation of pneumoperitoneum
Secondary Blood pressure Mean arterial pressure 5 minutes after installation of pneumoperitoneum
Secondary Blood pressure Mean arterial pressure 60 minutes after installation of pneumoperitoneum
Secondary Cardiac output Cardiac output (l/min) as measured by non invasive arterial pulse contour anlysis 5 minutes after installation of pneumoperitoneum
Secondary Cardiac output Cardiac output (l/min) as measured by non invasive arterial pulse contour anlysis 30 minutes after installation of pneumoperitoneum
Secondary Cardiac output Cardiac output (l/min) as measured by non invasive arterial pulse contour anlysis 60 minutes after installation of pneumoperitoneum
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