Neuromuscular BlockadePhase 4BENNNCT02410590
Rocuronium + Sugammadex vs. Succinylcholine + Cisatracurium + Neostigmine/Atropine in Obese Participants (MK-8616-104)
A Phase 4 study testing Rocuronium, Sugammadex and Cisatracurium in people with Neuromuscular Blockade, run by Merck Sharp & Dohme LLC.
Trial summary
The primary objective of this trial is to compare the preference between two strategies of neuromuscular blocking (NMB) / reversal in adult obese patients undergoing laparoscopic abdominal surgery: Rocuronium + Sugammadex versus Succinylcholine + Cisatracurium + Neostigmine/Atropine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Rocuronium, Sugammadex and Cisatracurium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Oct 2016
- Phase
- Phase 4
- 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
- must be obese, with a Body Mass Index ≥30.0 to ≤50.
- must be scheduled to undergo an elective abdominal laparoscopic surgery, under general anesthesia. (Participants are expected to remain in the hospital for at least 24 hours following surgical procedure.)
- must be categorized as American Society of Anesthesiologists (ASA) Class 1, 2, or 3.
- clinical laboratory tests within normal limits or clinically acceptable to the investigator/sponsor.
- sexually active females of child-bearing potential must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for the 30 days after stopping the medication. Medically accepted methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, inert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal ligation). Postmenopausal women are not required to use contraception. Postmenopausal is defined as at least 12 consecutive months without a spontaneous menstrual period. Each sexually active male subject with a female partner(s) of childbearing potential must also provide written informed consent to provide information regarding any pregnancy.
Who cannot join
- has anatomical malformations that may lead to difficult intubation.
- is known or suspected to have neuromuscular disorders that may affect NMB and/or trial assessments.
- history of previous abdominal laparoscopy procedures.
- must not currently (within past 6 months) meet DSM-IV-TR criteria for substance abuse or dependence (excluding nicotine).
- history of a chronic pain condition (requiring continuous/daily pain medication prior to surgery).
- females who have given birth to one or more children in the last 12 months, or are pregnant or intend to become pregnant between randomization and >Day 30 pregnancy follow-up contact [premenopausal female of childbearing potential].
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- evidence of acute cholecystitis.
- dialysis-dependency or suspected of having severe renal insufficiency (defined as estimated creatinine clearance of <30 mL/min).
- significant hepatic dysfunction that would prevent participation in the trial, based on the summary of product characteristics of the study drugs.
- history of or family history of malignant hyperthermia.
- known allergy to trial treatments (rocuronium, sugammadex, succinylcholine, cisatracurium, neostigmine, atropine) or their excipients, to opioids/opiates, or other medication used during general anesthesia.
- expected transfer to intensive care unit after surgery.
- must continue to receive toremifene or fusidic acid during the trial.
- has participated in another clinical trial within 30 days of signing the informed consent form of the current trial.
About this study
Official title: Randomized, Parallel Group, Controlled Trial to Compare Two Different "NMB + Reversal" Strategies in Adult Obese Patients Undergoing Laparoscopic Abdominal Surgery
The primary objective of this trial is to compare the preference between two strategies of neuromuscular blocking (NMB) / reversal in adult obese patients undergoing laparoscopic abdominal surgery: Rocuronium + Sugammadex versus Succinylcholine + Cisatracurium + Neostigmine/Atropine. This will be done evaluating the average verbal numerical scale (VNS) scores obtained from surgeons blinded to the drugs administered. The primary hypothesis is that the strategy "Rocuronium + Sugammadex" provides a better surgical visual field in obese participants undergoing laparoscopic abdominal surgery than the strategy "Succinylcholine + Cisatracurium + Neostigmine/Atropine" as measured by VNS scores.
- Conditions
- Neuromuscular Blockade
- Being tested
- Rocuronium, Sugammadex, Cisatracurium, Neostigmine/Atropine, Succinylcholine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
SugammadexDrug
CisatracuriumDrug
Neostigmine/AtropineDrug
SuccinylcholineDrug
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium + Sugammadex | Experimental | Participants will receive rocuronium administered at a dosage adequate to make intubation possible and provide deep NMB (defined as no response to train-of-four stimulation but at least one response to five post-tetanic count [PTC]) for the duration of surgery, until the end of the procedure. Sugammadex will be administered to participants once at a dosage of 4 mg/kg real body weight (RBW) IV at the end of surgical procedure. Sugammadex will be used as the only reversal drug in all participants who receive rocuronium as a neuromuscular blocker. Receives: Drug: Rocuronium; Drug: Sugammadex |
| Succinylcholine + Cisatracurium + Neostigmine/Atropine | Active comparator | After receiving succinylcholine 1.0 mg/kg RBW for intubation, participants will receive cisatracurium administered at dosage adequate to have a moderate NMB (defined as a target of TOF ratio = 10% with a range: 2-3 twitches to TOF ratio of 20%) for the duration of surgery, until the end of the procedure. Neostigmine/Atropine will be administered to participants once at respective dosage of 0.05 mg/kg RBW and 0.01 mg/kg RBW at least after the reappearance of T2 after surgery completion. The maximum allowed dosage for Neostigmine is 5 mg. Neostigmine will be used as only reversal drug in all participants who received Cisatracurium as neuromuscular blocker. Receives: Drug: Cisatracurium; Drug: Neostigmine/Atropine; Drug: Succinylcholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Surgeons who prefer Rocuronium + Sugammadex vs. Succinylcholine + Cisatracurium + Neostigmine/Atropine for neuromuscular blocking/reversal in obese participants undergoing laparoscopic abdominal surgery
Measured: Up to 1 hour after end of surgery
Secondary outcomes (2)
Time elapsed from end of surgery to extubation
Measured: Up to 1 hour after end of surgery
Time elapsed from start of reversal drug administration to train-of-four (TOF) ratio ≥0.9
Measured: Up to 1 hour after start of reversal drug treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (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.
- More trials run by Merck Sharp & Dohme LLCThe 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410590
- Sponsor's protocol ID
- 8616-104
- Other IDs
- 2013-004423-36
- Acronym
- BENN
- Status last verified
- Jul 2015
- First submitted
- 2 Apr 2015
- Last updated
- 13 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Parallel Group, Controlled Trial to Compare Two Different "NMB + Reversal" Strategies in Adult Obese Patients Undergoing Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02410590
- Acronym / sponsor ID
- BENN / 8616-104
- Conditions
- Neuromuscular Blockade
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 7 Apr 2015 (estimated)
- 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 objective of this trial is to compare the preference between two strategies of neuromuscular blocking (NMB) / reversal in adult obese patients undergoing laparoscopic abdominal surgery: Rocuronium + Sugammadex versus Succinylcholine + Cisatracurium + Neostigmine/Atropine. This will be done evaluating the average verbal numerical scale (VNS) scores obtained from surgeons blinded to the drugs administered. The primary hypothesis is that the strategy "Rocuronium + Sugammadex" provides a better surgical visual field in obese participants undergoing laparoscopic abdominal surgery than the strategy "Succinylcholine + Cisatracurium + Neostigmine/Atropine" as measured by VNS scores.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocuronium + Sugammadex | Experimental | Drug: Rocuronium, Drug: SugammadexParticipants will receive rocuronium administered at a dosage adequate to make intubation possible and provide deep NMB (defined as no response to train-of-four stimulation but at least one response to five post-tetanic count [PTC]) for the duration of surgery, until the end of the procedure. Sugammadex will be administered to participants once at a dosage of 4 mg/kg real body weight (RBW) IV at the end of surgical procedure. Sugammadex will be used as the only reversal drug in all participants who receive rocuronium as a neuromuscular blocker. |
| Succinylcholine + Cisatracurium + Neostigmine/Atropine | Active comparator | Drug: Cisatracurium, Drug: Neostigmine/Atropine, Drug: SuccinylcholineAfter receiving succinylcholine 1.0 mg/kg RBW for intubation, participants will receive cisatracurium administered at dosage adequate to have a moderate NMB (defined as a target of TOF ratio = 10% with a range: 2-3 twitches to TOF ratio of 20%) for the duration of surgery, until the end of the procedure. Neostigmine/Atropine will be administered to participants once at respective dosage of 0.05 mg/kg RBW and 0.01 mg/kg RBW at least after the reappearance of T2 after surgery completion. The maximum allowed dosage for Neostigmine is 5 mg. Neostigmine will be used as only reversal drug in all participants who received Cisatracurium as neuromuscular blocker. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- must be obese, with a Body Mass Index ≥30.0 to ≤50.
- must be scheduled to undergo an elective abdominal laparoscopic surgery, under general anesthesia. (Participants are expected to remain in the hospital for at least 24 hours following surgical procedure.)
- must be categorized as American Society of Anesthesiologists (ASA) Class 1, 2, or 3.
- clinical laboratory tests within normal limits or clinically acceptable to the investigator/sponsor.
- sexually active females of child-bearing potential must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for the 30 days after stopping the medication. Medically accepted methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, inert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal ligation). Postmenopausal women are not required to use contraception. Postmenopausal is defined as at least 12 consecutive months without a spontaneous menstrual period. Each sexually active male subject with a female partner(s) of childbearing potential must also provide written informed consent to provide information regarding any pregnancy.
Key exclusion criteria (14 listed)
- has anatomical malformations that may lead to difficult intubation.
- is known or suspected to have neuromuscular disorders that may affect NMB and/or trial assessments.
- history of previous abdominal laparoscopy procedures.
- must not currently (within past 6 months) meet DSM-IV-TR criteria for substance abuse or dependence (excluding nicotine).
- history of a chronic pain condition (requiring continuous/daily pain medication prior to surgery).
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 |
|---|---|---|
| Rocuronium | Drug | Rocuronium + Sugammadex |
| Sugammadex | Drug | Rocuronium + Sugammadex |
| Cisatracurium | Drug | Succinylcholine + Cisatracurium + Neostigmine/Atropine |
| Neostigmine/Atropine | Drug | Succinylcholine + Cisatracurium + Neostigmine/Atropine |
| Succinylcholine | Drug | Succinylcholine + Cisatracurium + Neostigmine/Atropine |
Primary outcome
Number of Surgeons who prefer Rocuronium + Sugammadex vs. Succinylcholine + Cisatracurium + Neostigmine/Atropine for neuromuscular blocking/reversal in obese participants undergoing laparoscopic abdominal surgery
Time frame: Up to 1 hour after end of surgery
2 secondary outcomes
Time elapsed from end of surgery to extubation
Time frame: Up to 1 hour after end of surgery
Time elapsed from start of reversal drug administration to train-of-four (TOF) ratio ≥0.9
Time frame: Up to 1 hour after start of reversal drug treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocuronium, Sugammadex and Cisatracurium in people with Neuromuscular Blockade, run by Merck Sharp & Dohme LLC.
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 5 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: withdrawn, as of the sponsor's last update on 13 Jul 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of Surgeons who prefer Rocuronium + Sugammadex vs. Succinylcholine + Cisatracurium + Neostigmine/Atropine for neuromuscular blocking/reversal in obese participants undergoing laparoscopic abdominal surgery (time frame: Up to 1 hour after end of 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 13 Jul 2015.