Hemodynamic InstabilityRELAX-LAPNCT04076709
Cardiovascular Effects of Muscle Relaxation During Laparoscopic Surgery
A study testing goal directed anaesthesia in people with Hemodynamic Instability, run by Leiden University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- goal directed anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2020to 27 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-3;
- Scheduled for lower laparoscopic abdominal surgery;
- Ability to give oral and written consent;
Who cannot join
- 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;
Show all 14Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
- Conditions
- Hemodynamic Instability
- Being tested
- goal directed anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
goal directed anaesthesiaProcedure or surgery
Deep neuromuscular blockade (PTC 1-2) Nociception level index (NOL) target 10-25
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Not described |
| Goal directed anesthesia | Experimental | Deep neuromuscular blockade (post tetanic count 1-2 twitches) and nociception guided anaesthesia Receives: Procedure: goal directed anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Mean arterial pressure
Measured: 30 minutes after installation of pneumoperitoneum
Secondary outcomes (5)
Blood pressure
Mean arterial pressure
Measured: 5 minutes after installation of pneumoperitoneum
Blood pressure
Mean arterial pressure
Measured: 60 minutes after installation of pneumoperitoneum
Cardiac output
Cardiac output (l/min) as measured by non invasive arterial pulse contour anlysis
Measured: 5 minutes after installation of pneumoperitoneum
Cardiac output
Cardiac output (l/min) as measured by non invasive arterial pulse contour anlysis
Measured: 30 minutes after installation of pneumoperitoneum
Cardiac output
Cardiac output (l/min) as measured by non invasive arterial pulse contour anlysis
Measured: 60 minutes after installation of pneumoperitoneum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start1 Sep 2020
- Primary completion26 Mar 2025
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martijn Boon, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076709
- Sponsor's protocol ID
- P19.042
- Acronym
- RELAX-LAP
- Status last verified
- Mar 2025
- First submitted
- 21 Aug 2019
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Neuromuscular Relaxation and Nociception Guided Anaesthesia on Hemodynamic Variables During Lower Abdominal Laparoscopic Surgery: a Strategy Trial.
- ClinicalTrials.gov ID
- NCT04076709
- Acronym / sponsor ID
- RELAX-LAP / P19.042
- Conditions
- Hemodynamic Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | – |
| Goal directed anesthesia | Experimental | Procedure: goal directed anaesthesiaDeep neuromuscular blockade (post tetanic count 1-2 twitches) and nociception guided anaesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA 1-3;
- Scheduled for lower laparoscopic abdominal surgery;
- Ability to give oral and written consent;
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| goal directed anaesthesiaDeep neuromuscular blockade (PTC 1-2) Nociception level index (NOL) target 10-25 | Procedure or surgery | Goal directed anesthesia |
Primary outcome
Blood pressure
Time frame: 30 minutes after installation of pneumoperitoneum
Mean arterial pressure
5 secondary outcomes
Blood pressure
Time frame: 5 minutes after installation of pneumoperitoneum
Blood pressure
Time frame: 60 minutes after installation of pneumoperitoneum
Cardiac output
Time frame: 5 minutes after installation of pneumoperitoneum
Cardiac output
Time frame: 30 minutes after installation of pneumoperitoneum
Cardiac output
Time frame: 60 minutes after installation of pneumoperitoneum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
Related trials for Hemodynamic Instability
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing goal directed anaesthesia in people with Hemodynamic Instability, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 30 minutes after installation of pneumoperitoneum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.