Hemodynamic Instability Clinical Trial
— RELAX-LAPOfficial title:
The Impact of Neuromuscular Relaxation and Nociception Guided Anaesthesia on Hemodynamic Variables During Lower Abdominal Laparoscopic Surgery: a Strategy Trial.
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.
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). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center |
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 |
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 |
NCT01605279 -
Dobutamine Versus Placebo for Low Superior Vena Cava Flow in Newborns
|
Phase 2 | |
Completed |
NCT01559675 -
Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery
|
N/A | |
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 |
NCT05481047 -
Prevention or Treatment of Arterial Hypotension and Oxygen Cerebral Saturation During Major Abdominal Surgery
|
N/A | |
Completed |
NCT06158165 -
Evaluating The Cardiovascular Effects of Tourniquet Application
|
||
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 |