Neuromuscular BlockadeNCT06553066
Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery
A study testing Deep neuromascular blockage and Moderate neuromascular blockage in people with Neuromuscular Blockade, run by University Hospital of Patras.
Trial summary
The aim of this study is to investigate the effect of depth of neuromuscular blockade on the surgical field, patient postoperative pain, intestinal motility, the incidence of postoperative nausea and vomiting and the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Deep neuromascular blockage and Moderate neuromascular blockage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Aug 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years ASA II-III who are to undergo planned laparoscopic bariatric surgery
Who cannot join
- ASA 4 patients
- Maternal population
- Patients who are not scheduled to receive general anesthesia, but some other type of anesthesia.
- Contraindicated patients: administration of neuromuscular blockade, suppression of spontaneous respiration, and those with an indication for awake intubation or surgical airway.
- Patients with neuromuscular diseases
- Patients who refuse to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery:
The aim of this study is to investigate the effect of depth of neuromuscular blockade on the surgical field, patient postoperative pain, intestinal motility, the incidence of postoperative nausea and vomiting and the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography.This is a prospective, randomized, controlled clinical-controlled study in patients ≥18 years old scheduled to undergo elective bariatric surgery.
- Conditions
- Neuromuscular Blockade
- Being tested
- Deep neuromascular blockage, Moderate neuromascular blockage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep neuromascular blockageDrug
Also called Rocuronium and Sugammadex
maintenance of a deep neuromuscular block with rocuronium, titrated to maintain a TOF count of 0, and a PTC between 1-2.
Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale(Leiden scale : 1 indicates extremely poor conditions, 2 poor conditions, 3 acceptable conditions, 4, good conditions and 5 optimal conditions)
Moderate neuromascular blockageDrug
Also called Rocuronium and Sugammadex
maintenance of a moderate neuromuscular block with rocuronium, titrated to maintain a TOF count of 1-2
| Study group | Role | What they receive |
|---|---|---|
| Group DNMB ( Deep neuromascular blockage) | Experimental | Deep Neuromuscular Block group Intervention: maintenance of a deep neuromuscular block with rocuronium, titrated to maintain a TOF count of 0, and a PTC between 1-2.
Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale(Leiden scale : 1 indicates extremely poor conditions, 2 poor conditions, 3 acceptable conditions, 4, good conditions and 5 optimal conditions) Receives: Drug: Deep neuromascular blockage; Drug: Moderate neuromascular blockage |
| Group MNMB ( Moderate neuromascular blockage) | Active comparator | Moderate Neuromuscular Block group Intervention: maintenance of a moderate neuromuscular block with rocuronium, titrated to obtain a TOF count of 1-3.
Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale(Leiden scale : 1 indicates extremely poor conditions, 2 poor conditions, 3 acceptable conditions, 4, good conditions and 5 optimal conditions) Receives: Drug: Deep neuromascular blockage; Drug: Moderate neuromascular blockage |
What is being measured
The primary outcome is the main question the study is designed to answer.
impact of a deep neuromuscular blockade on surgical conditions
impact of a deep neuromuscular blockade (TOF count = 0 and posttetanic count [PTC] 1-2) and a moderate neuromuscular blockade (TOF count= 1 - 3) on intraoperative surgical conditions assessed by the surgeon as a 5 points scale
Measured: During surgery
Secondary outcomes (17)
the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography.
quantitatively using chest computed tomography and expressed as percentage to total lung tissue volume
Measured: in the first six postoperative hours
Postoperative pain
Pain was measured four times in the PACU (at 15 min intervals starting upon arrival) and twice on the ward (8PM the day of surgery and 2 PM the next day).Pain was measured using an 11-point numerical rating scale (NRS), ranging from 0 (no pain) to 10 (most pain imaginable).
Measured: first postoperative day
Mean arterial pressure (mmHg)
measured before induction to general anesthesia, immediately after induction and every 15 min until the end of operation and immediately after awareness.at 15 min intervals starting upon arrival in the post anesthesia care unit
Measured: intraoperative and in Postanesthesia care unit
PIPcmH20 ( Peak inspiratory pressure)
Respiratory mechanical parameters were measured after intubation at suspine position, after insufflation of pneumoperitoneum , then the standard different positions of the patient ( Anti-Trendelenburg, supine, anti-trendelenburg and suspine position without premoperitoneum at the end of the procedure)
Measured: intraoperative
duration of surgery (hr)
from the incision to the last skin suture
Measured: intrapostoperative
The first flatus time (min)
the first time that patient flatus postoperative
Measured: up to 5 days
duration of anesthesia time (min)
time from anesthesia induction to Extubation
Measured: intraoperative
Postoperative nausea and vomiting (PONV)
incidence of PONV
Measured: until first postoperative day
Hospitalization time ( days)
FROM ADMISSION TO HOSPITAL TO DISCHARGE
Measured: up to 2 weeks
cumulative analgetid dose (mg)
cumulative analgetid dose until 2 PM the next day of the surgery
Measured: until 2 PM the next day of the surgery
oxygen saturation (SpO2) %
measured before induction to general anesthesia, immediately after induction and every 15 min until the end of operation and immediately after awareness.at 15 min intervals starting upon arrival in the post anesthesia care unit
Measured: intraoperative and in Postanesthesia care unit
tidal volume (ml)
Respiratory mechanical parameters were measured after intubation at suspine position, after insufflation of pneumoperitoneum , then the standard different positions of the patient ( Anti-Trendelenburg, supine, anti-trendelenburg and suspine position without premoperitoneum at the end of the procedure)
Measured: Intraoperative
Pplat cmH20 ( plateau pressure),
Respiratory mechanical parameters were measured after intubation at suspine position, after insufflation of pneumoperitoneum , then the standard different positions of the patient ( Anti-Trendelenburg, supine, anti-trendelenburg and suspine position without premoperitoneum at the end of the procedure)
Measured: Intraoperative
dynamic compliance ml/cmH20,
Respiratory mechanical parameters were measured after intubation at suspine position, after insufflation of pneumoperitoneum , then the standard different positions of the patient ( Anti-Trendelenburg, supine, anti-trendelenburg and suspine position without premoperitoneum at the end of the procedure)
Measured: Intraoperative
DP cmH20( Driving pressure)
Respiratory mechanical parameters were measured after intubation at suspine position, after insufflation of pneumoperitoneum , then the standard different positions of the patient ( Anti-Trendelenburg, supine, anti-trendelenburg and suspine position without premoperitoneum at the end of the procedure)
Measured: Intraoperative
Resistance cmH20/L/sec
Respiratory mechanical parameters were measured after intubation at suspine position, after insufflation of pneumoperitoneum , then the standard different positions of the patient ( Anti-Trendelenburg, supine, anti-trendelenburg and suspine position without premoperitoneum at the end of the procedure)
Measured: Intraoperative
PEEP cmH20
Respiratory mechanical parameters were measured after intubation at suspine position, after insufflation of pneumoperitoneum , then the standard different positions of the patient ( Anti-Trendelenburg, supine, anti-trendelenburg and suspine position without premoperitoneum at the end of the procedure)
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolas Drakos, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553066
- Sponsor's protocol ID
- Bariatric
- Status last verified
- Aug 2024
- First submitted
- 4 Jul 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery:
- ClinicalTrials.gov ID
- NCT06553066
- Acronym / sponsor ID
- Bariatric
- Conditions
- Neuromuscular Blockade
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 14 Aug 2024 (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.
The aim of this study is to investigate the effect of depth of neuromuscular blockade on the surgical field, patient postoperative pain, intestinal motility, the incidence of postoperative nausea and vomiting and the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography.This is a prospective, randomized, controlled clinical-controlled study in patients ≥18 years old scheduled to undergo elective bariatric surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group DNMB ( Deep neuromascular blockage) | Experimental | Drug: Deep neuromascular blockage, Drug: Moderate neuromascular blockageDeep Neuromuscular Block group Intervention: maintenance of a deep neuromuscular block with rocuronium, titrated to maintain a TOF count of 0, and a PTC between 1-2. Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale(Leiden scale : 1 indicates extremely poor conditions, 2 poor conditions, 3 acceptable conditions, 4, good conditions and 5 optimal conditions) |
| Group MNMB ( Moderate neuromascular blockage) | Active comparator | Drug: Deep neuromascular blockage, Drug: Moderate neuromascular blockageModerate Neuromuscular Block group Intervention: maintenance of a moderate neuromuscular block with rocuronium, titrated to obtain a TOF count of 1-3. Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale(Leiden scale : 1 indicates extremely poor conditions, 2 poor conditions, 3 acceptable conditions, 4, good conditions and 5 optimal conditions) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged ≥18 years ASA II-III who are to undergo planned laparoscopic bariatric surgery
Key exclusion criteria (6 listed)
- ASA 4 patients
- Maternal population
- Patients who are not scheduled to receive general anesthesia, but some other type of anesthesia.
- Contraindicated patients: administration of neuromuscular blockade, suppression of spontaneous respiration, and those with an indication for awake intubation or surgical airway.
- Patients with neuromuscular diseases
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 |
|---|---|---|
| Deep neuromascular blockageAlso: Rocuronium and Sugammadexmaintenance of a deep neuromuscular block with rocuronium, titrated to maintain a TOF count of 0, and a PTC between 1-2. Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale(Leiden scale : 1 indicates extremely poor conditions, 2 poor conditions, 3 acceptable conditions, 4, good conditions and 5 optimal conditions) | Drug | Group DNMB ( Deep neuromascular blockage), Group MNMB ( Moderate neuromascular blockage) |
| Moderate neuromascular blockageAlso: Rocuronium and Sugammadexmaintenance of a moderate neuromuscular block with rocuronium, titrated to maintain a TOF count of 1-2 | Drug | Group DNMB ( Deep neuromascular blockage), Group MNMB ( Moderate neuromascular blockage) |
Primary outcome
impact of a deep neuromuscular blockade on surgical conditions
Time frame: During surgery
impact of a deep neuromuscular blockade (TOF count = 0 and posttetanic count [PTC] 1-2) and a moderate neuromuscular blockade (TOF count= 1 - 3) on intraoperative surgical conditions assessed by the surgeon as a 5 points scale
17 secondary outcomes
the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography.
Time frame: in the first six postoperative hours
Postoperative pain
Time frame: first postoperative day
Mean arterial pressure (mmHg)
Time frame: intraoperative and in Postanesthesia care unit
PIPcmH20 ( Peak inspiratory pressure)
Time frame: intraoperative
duration of surgery (hr)
Time frame: intrapostoperative
The first flatus time (min)
Time frame: up to 5 days
duration of anesthesia time (min)
Time frame: intraoperative
Postoperative nausea and vomiting (PONV)
Time frame: until first postoperative day
Hospitalization time ( days)
Time frame: up to 2 weeks
cumulative analgetid dose (mg)
Time frame: until 2 PM the next day of the surgery
oxygen saturation (SpO2) %
Time frame: intraoperative and in Postanesthesia care unit
tidal volume (ml)
Time frame: Intraoperative
Pplat cmH20 ( plateau pressure),
Time frame: Intraoperative
dynamic compliance ml/cmH20,
Time frame: Intraoperative
DP cmH20( Driving pressure)
Time frame: Intraoperative
Resistance cmH20/L/sec
Time frame: Intraoperative
PEEP cmH20
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Deep neuromascular blockage and Moderate neuromascular blockage in people with Neuromuscular Blockade, run by University Hospital of Patras.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikolas Drakos, MD (+306998429336, nikolasdrakos@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impact of a deep neuromuscular blockade on surgical conditions (time frame: During surgery). 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 14 Aug 2024.