Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT03653910 - Effect-site Concentration of Remifentanil for Double-lumen Tubes Intubation: Airtraq VS Macintosh Laryngoscope N/A
Completed NCT06000098 - Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy
Recruiting NCT02565251 - Volemic Resuscitation in Sepsis and Septic Shock N/A
Terminated NCT02365688 - Hemodynamic Response During Goal Directed Fluid Therapy in the OR N/A
Completed NCT01559675 - Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery N/A
Completed NCT01605279 - Dobutamine Versus Placebo for Low Superior Vena Cava Flow in Newborns Phase 2
Recruiting NCT04010058 - Postoperative Continuous Non-invasive Haemodynamic Monitoring on the Ward N/A
Completed NCT06268275 - Comparison of Effects of Scalp Block and Intravenous Esmolol on Hemodynamic Response Following the Skull Pins Application for Elective Supratentorial Craniotomy N/A
Recruiting NCT04926220 - Dynamic Estimation of Cardiac Output in the Operating Room
Not yet recruiting NCT05003011 - Correlation of Hemodynamics Via Pulmonary Artery Catherization and the Cardiospire
Completed NCT03599440 - Effect of Extended Infusion Lines on Pulse Contour-based Measurements
Completed NCT05035485 - Maternal Cardiac Output Response to Rescue Norepinephrine and Phenylephrine Boluses in Patients With Severe Preeclampsia N/A
Not yet recruiting NCT04227821 - Hemodynamic Optimalization in Pediatric Patients
Completed NCT06158165 - Evaluating The Cardiovascular Effects of Tourniquet Application
Completed NCT05481047 - Prevention or Treatment of Arterial Hypotension and Oxygen Cerebral Saturation During Major Abdominal Surgery N/A
Not yet recruiting NCT03828032 - Multi-parameters'Change Process During Dehydration Therapy on Brain Edema Patients. N/A
Completed NCT04089098 - VOLume and Vasopressor Therapy in Patients With Hemodynamic instAbility
Recruiting NCT05570682 - Manually Controlled Infusion vs Target Controlled Infusion for StrokeThrombectomy N/A
Completed NCT04574908 - A Pilot Trial of Continuous Portable Postoperative Hemodynamic And Saturation Monitoring On Hospital Wards N/A
Recruiting NCT06071026 - Hemodynamic Effects of Variations in Net Ultrafiltration Rate During Continuous Renal Replacement Therapy. N/A