Cardiovascular Effects of Muscle Relaxation During Laparoscopic Surgery

Hemodynamic Instability Clinical Trial

— RELAX-LAP  

Official title:

The Impact of Neuromuscular Relaxation and Nociception Guided Anaesthesia on Hemodynamic Variables During Lower Abdominal Laparoscopic Surgery: a Strategy Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04076709
• Other study ID #: P19.042
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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).

Related Conditions & MeSH terms

• Hemodynamic Instability

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