Curarization, Postoperative ResidualPhase 2NCT03519724
Role of Curarization During Anesthesia for Gynecologic Surgical Laparotomy Procedures
A Phase 2 study testing Sugammadex and Neostigmine in people with Curarization, Postoperative Residual, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
The primary outcome of this study is to investigate whether deep NMB reversed with Sugammadex is superior to moderate NMB reversed with Neostigmine, in terms of overall pain in the first 48 hrs after laparoscopic gynecologic surgery, reversal time from NMB (TOF≥0.9) and direct and indirect costs. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Curarization, Postoperative Residual
- What is being tested?
- Sugammadex and Neostigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jul 2018to 30 Jan 2019
- Phase
- Phase 2
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years BMI between 16 and 40 Kg/m2 ECOG Performance Status tra 0 e 1 American Society Anesthesiologist (ASA) class 1 or 3 Able to provide informed consent to trial procedures
Who cannot join
- Age < 18 or > 75 years
- BMI <16 o > 40 Kg/m2
- ECOG Performance Status >1
- Pregnancy
- Active or recent pelvic inflammation
- Anticipated airway difficulty
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- Patients with history of allergy to rocuronium, neostigmine or sugammadex
- Allergy to NSAIDs
- Previous opioids consumption for chronic pain
- Patients receiving drugs for different medical conditions, that may prolong or shorten the duration of rocuronium effect (e.g aminoglycosides, magnesium)
- Hepatic or renal failure
- Persistent coagulopathy
- Neurological or cognitive disorders
- Conversion from laparoscopic to open surgery Onset of intraoperative complications
Trial locations and contacts
1 site in 1 country.
Italy1 site
Campus Bio-medico
Roma, RM, 00128
Corrado Terranova, 06225411203 ext. +39, c.terranova@unicampus.it
About this study
Official title: The Role of Curarization During Anesthesia for Gynecologic Laparotomy Surgical Procedures: a Double Blind Randomized Controlled Trial
The primary outcome of this study is to investigate whether deep NMB reversed with Sugammadex is superior to moderate NMB reversed with Neostigmine, in terms of overall pain in the first 48 hrs after laparoscopic gynecologic surgery, reversal time from NMB (TOF≥0.9) and direct and indirect costs. Additionally we will also assess: drugs consumption for pain and antiemetics (rescue dose), surgical conditions, hemodynamic and respiratory stability, operation time, anesthesia time, total amount and flow rate of CO2, insufflation time, resolution of post-operative ileus, dry mouth and PONV in the first 48 hours, patient satisfaction
- Conditions
- Curarization, Postoperative Residual
- Being tested
- Sugammadex, Neostigmine
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Reversal of deep NMB
NeostigmineDrug
Reversal of moderate NMB
| Study group | Role | What they receive |
|---|---|---|
| SUG | Experimental | Not described Receives: Drug: Sugammadex |
| NEO | Active comparator | Not described Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall pain in the first 48 hrs after gynecologic surgical procedures
0 - 10 NRS scale of the overall pain in the first 48 hrs after gynecologic surgical procedures
Measured: First 48 hrs after gynecologic surgical procedures
Recovery time (or Reversal time) from NMB (TOF≥0.9)
The recovery time (or Reversal time) will be measured in minutes from the administration of reversal agent to a TOF≥0.9
Measured: The recovery time (or Reversal time) will be measured in minutes after the administration of reversal agent at the end of the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start30 Jul 2018 (estimated)
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Curarization, Postoperative ResidualStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corrado Terranova, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519724
- Sponsor's protocol ID
- GYN LPTM-CUR 2018
- Status last verified
- Jul 2018
- First submitted
- 9 Mar 2018
- Last updated
- 10 Jul 2018
- Results posted
- 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 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Curarization During Anesthesia for Gynecologic Laparotomy Surgical Procedures: a Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03519724
- Acronym / sponsor ID
- GYN LPTM-CUR 2018
- Conditions
- Curarization, Postoperative Residual
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 30 Jul 2018 (estimated)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Jan 2019 (estimated)
- First posted
- 9 May 2018 (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 primary outcome of this study is to investigate whether deep NMB reversed with Sugammadex is superior to moderate NMB reversed with Neostigmine, in terms of overall pain in the first 48 hrs after laparoscopic gynecologic surgery, reversal time from NMB (TOF≥0.9) and direct and indirect costs. Additionally we will also assess: drugs consumption for pain and antiemetics (rescue dose), surgical conditions, hemodynamic and respiratory stability, operation time, anesthesia time, total amount and flow rate of CO2, insufflation time, resolution of post-operative ileus, dry mouth and PONV in the first 48 hours, patient satisfaction
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUG | Experimental | Drug: Sugammadex |
| NEO | Active comparator | Drug: Neostigmine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-75 years BMI between 16 and 40 Kg/m2 ECOG Performance Status tra 0 e 1 American Society Anesthesiologist (ASA) class 1 or 3 Able to provide informed consent to trial procedures
Key exclusion criteria (14 listed)
- Age < 18 or > 75 years
- BMI <16 o > 40 Kg/m2
- ECOG Performance Status >1
- Pregnancy
- Active or recent pelvic inflammation
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 |
|---|---|---|
| SugammadexReversal of deep NMB | Drug | SUG |
| NeostigmineReversal of moderate NMB | Drug | NEO |
Primary outcome
Overall pain in the first 48 hrs after gynecologic surgical procedures
Time frame: First 48 hrs after gynecologic surgical procedures
0 - 10 NRS scale of the overall pain in the first 48 hrs after gynecologic surgical procedures
Recovery time (or Reversal time) from NMB (TOF≥0.9)
Time frame: The recovery time (or Reversal time) will be measured in minutes after the administration of reversal agent at the end of the surgical procedure
The recovery time (or Reversal time) will be measured in minutes from the administration of reversal agent to a TOF≥0.9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sugammadex and Neostigmine in people with Curarization, Postoperative Residual, run by Campus Bio-Medico University at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 10 Jul 2018. 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 Italy. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall pain in the first 48 hrs after gynecologic surgical procedures (time frame: First 48 hrs after gynecologic surgical procedures). The study lists 2 primary outcomes in all. 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 10 Jul 2018.