Anesthesia RecoveryPhase 4NCT02375217
"Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"
A Phase 4 study testing Sugammadex, Neostigmine and glycopyrrolate in people with Anesthesia Recovery, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Prospective Randomized non inferiority Trial involving adult patients undergoing elective surgery under general anesthesia.56 Patients will be enrolled in 2 groups : full dose sugammadex vs half dose sugammadex for reversal of NMB. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Recovery
- What is being tested?
- Sugammadex, Neostigmine and glycopyrrolate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteLebanon
- Study dates
- Oct 2014to Oct 2015
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18-70
- ASA class I, II, and III
- undergoing surgery under balanced general anesthesia requiring the use of muscle relaxants throughout the surgery
Who cannot join
- patients undergoing emergency surgeries
- pregnant patients
- patients with end stage renal disease or chronic kidney disease(GFR less than 60)
- patients with allergy to sugammadex or who had previous complications or side effects from previous sugammadex administration
- patients' refusal
- patients with allergy to recuronium
Trial locations and contacts
1 site in 1 country.
About this study
Prospective Randomized non inferiority Trial involving adult patients undergoing elective surgery under general anesthesia.56 Patients will be enrolled in 2 groups : full dose sugammadex vs half dose sugammadex for reversal of NMB.
Read the detailed description
The investigators' aim is to prove that half dose sugammadex in combination with neostigmine 0.05 mg/kg is non-inferior to the recommended dose of sugammadex for the reversal of deep ( absence of Trian of Four response :TOF) or moderate ( TOF 1 or 2 twiches) muscle paralysis in patients undergoing surgery under general anesthesia.
- Conditions
- Anesthesia Recovery
- Being tested
- Sugammadex, Neostigmine, glycopyrrolate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
half dose
SugammadexDrug
full dose
NeostigmineDrug
IV = 50mcg/kg
glycopyrrolateDrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : (NS) | Active comparator | Group 1 Drug combination:
patients receive half of the recommended dose of sugammadex plus dose of neostigmine"
1. Sugammadex IV= -1 mg/kg( moderate NMB) or
* 2 mg/kg (deep NMB)
2. neostigmine IV = 50mcg/kg
3. glycopyrrolate 10 mcg/kg Receives: Drug: Sugammadex; Drug: Neostigmine; Drug: glycopyrrolate |
| Group 2 : (S) | Active comparator | patients receive Full recommended dose of sugammadex
Sugammadex IV= 2mg/kg (Moderate NMB) 4mg/kg ( Deep NMB) Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
TOF ratio of 0.9
Measured: within 5 minutes
Secondary outcomes (2)
the time to return of TOF ratio to 0.9 and the time till extubation
Measured: within 10 minutes
Residual neuro-muscular blockade
Post Anesthesia recovery unit
Measured: within 10 to 180 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia RecoveryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marie Awad, American University of Beirut Medical Center
- Investigators
- Marie Mn Aouad,, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375217
- Sponsor's protocol ID
- ANES.MA.14
- Status last verified
- Jun 2018
- First submitted
- 11 Feb 2015
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Aouad MT, Alfahel WS, Kaddoum RN, Siddik-Sayyid SM. Half dose sugammadex combined with neostigmine is non-inferior to full dose sugammadex for reversal of rocuronium-induced deep neuromuscular blockade: a cost-saving strategy. BMC Anesthesiol. 2017 Apr 11;17(1):57. doi: 10.1186/s12871-017-0348-9.
PubMed 28399799
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"
- ClinicalTrials.gov ID
- NCT02375217
- Acronym / sponsor ID
- ANES.MA.14
- Conditions
- Anesthesia Recovery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Mar 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.
Prospective Randomized non inferiority Trial involving adult patients undergoing elective surgery under general anesthesia.56 Patients will be enrolled in 2 groups : full dose sugammadex vs half dose sugammadex for reversal of NMB.
Detailed description
The investigators' aim is to prove that half dose sugammadex in combination with neostigmine 0.05 mg/kg is non-inferior to the recommended dose of sugammadex for the reversal of deep ( absence of Trian of Four response :TOF) or moderate ( TOF 1 or 2 twiches) muscle paralysis in patients undergoing surgery under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : (NS) | Active comparator | Drug: Sugammadex, Drug: Neostigmine, Drug: glycopyrrolateGroup 1 Drug combination: patients receive half of the recommended dose of sugammadex plus dose of neostigmine" 1. Sugammadex IV= -1 mg/kg( moderate NMB) or * 2 mg/kg (deep NMB) 2. neostigmine IV = 50mcg/kg 3. glycopyrrolate 10 mcg/kg |
| Group 2 : (S) | Active comparator | Drug: Sugammadexpatients receive Full recommended dose of sugammadex Sugammadex IV= 2mg/kg (Moderate NMB) 4mg/kg ( Deep NMB) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-70
- ASA class I, II, and III
- undergoing surgery under balanced general anesthesia requiring the use of muscle relaxants throughout the surgery
Key exclusion criteria (6 listed)
- patients undergoing emergency surgeries
- pregnant patients
- patients with end stage renal disease or chronic kidney disease(GFR less than 60)
- patients with allergy to sugammadex or who had previous complications or side effects from previous sugammadex administration
- patients' refusal
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 |
|---|---|---|
| Sugammadexhalf dose | Drug | Group 1 : (NS) |
| Sugammadexfull dose | Drug | Group 2 : (S) |
| NeostigmineIV = 50mcg/kg | Drug | Group 1 : (NS) |
| glycopyrrolate | Drug | Group 1 : (NS) |
Primary outcome
TOF ratio of 0.9
Time frame: within 5 minutes
2 secondary outcomes
the time to return of TOF ratio to 0.9 and the time till extubation
Time frame: within 10 minutes
Residual neuro-muscular blockade
Time frame: within 10 to 180 mins
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 27 Jun 2018.
- Derived from this study: PubMed 28399799Aouad MT, Alfahel WS, Kaddoum RN, Siddik-Sayyid SM. Half dose sugammadex combined with neostigmine is non-inferior to full dose sugammadex for reversal of rocuronium-induced deep neuromuscular blockade: a cost-saving strategy. BMC Anesthesiol. 2017 Apr 11;17(1):57. doi: 10.1186/s12871-017-0348-9.
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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.
Marie Mn Aouad,, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sugammadex, Neostigmine and glycopyrrolate in people with Anesthesia Recovery, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 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: finished, as of the sponsor's last update on 27 Jun 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 Lebanon. 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 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 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?
TOF ratio of 0.9 (time frame: within 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02375217, which also lists 1 linked publication.
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 27 Jun 2018.