Pre-eclampsia AggravatedPhase 4NCT01972659
Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients
A Phase 4 study testing Magnesium Sulphate and sugammadex in people with Pre-eclampsia Aggravated, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Background: The aim of this prospective study was to evaluate the effect of magnesium on the reversal of rocuronium-induced neuromuscular block by sugammadex. Methods: Eighty patients, aged 18 to 60 years, American Society of Anesthesiologists I-II, undergoing elective gynecological surgery were enrolled. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pre-eclampsia Aggravated
- What is being tested?
- Magnesium Sulphate and sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2012to Dec 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female patients
- American Society of Anesthesiologists (ASA) physical status I or II
- 18-60 years of age who were undergoing elective gynecological surgery
- requiring endotracheal intubation were enrolled in this prospective study.
Who cannot join
- Patients who had body mass index > 35
- gastroesophageal reflux
- a history of allergy
- used medication known to interact with the drugs being used in this trial
- who experienced expected or unexpected difficulty during intubation or ventilation
- had neuromuscular disease
Show all 10Show fewer
- hepatic or renal insufficiency
- were pregnant
- had a family history of malignant hyperthermia
- detection if low or high control plasma magnesium levels
Trial locations and contacts
1 site in 1 country.
About this study
Background: The aim of this prospective study was to evaluate the effect of magnesium on the reversal of rocuronium-induced neuromuscular block by sugammadex.
Methods: Eighty patients, aged 18 to 60 years, American Society of Anesthesiologists I-II, undergoing elective gynecological surgery were enrolled. Anaesthesia was induced with propofol and fentanyl and was maintained with 60% nitrous oxide and Oxygen in sevoflurane. The magnesium group received 50 milligram/kilogram (mg/kg) Magnesium intravenous (iv) as a bolus and 15 mg/kg/hour by continuous infusion until the completion of surgery. The placebo group received the equivalent volume of isotonic saline. For intubation, 0.6 mg/kg rocuronium was administered and 0.1 mg/kg was added when Train of four (TOF) counts reached 1 or more during the procedure. At the end of the surgery at a TOF count of 1, 4 mg/kg sugammadex iv was administered. Patients were observed until a TOF ratio of 0.9 was achieved. Patient-controlled analgesia with intravenous morphine was used postoperatively.
Read the detailed description
Inclusion criteria:
- American Society of Anesthesiologists physical status I or II
- 18-60 years of age
- undergoing elective gynecological surgery
- requiring endotracheal intubation
Exclusion criteria:
- Patients who had body mass index > 35
- gastroesophageal reflux
- a history of allergy
- used medication known to interact with the drugs being used in this trial
- who experienced expected or unexpected difficulty during intubation or ventilation
- had neuromuscular disease
- hepatic or renal insufficiency
- pregnant
- were American Society of Anesthesiologists III or IV
- had a family history of malignant hyperthermia
- detection if low or high control plasma magnesium levels
- Conditions
- Pre-eclampsia Aggravated
- Being tested
- placebo, Magnesium Sulphate, sugammadex
- Keywords
- sugammadex, rocuronium, magnesium, female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Also called %0.9 NaCl, isotonic saline
Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion
Magnesium SulphateDrug
Also called magnesium
Experimental :
50 mg/kg bolus plus 15 mg/kg continuous infusion
sugammadexDrug
Also called bridion
4 mg/kg iv bolus at the end of the surgery
| Study group | Role | What they receive |
|---|---|---|
| sugammadex and placebo | Active comparator | sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery Receives: Drug: placebo; Drug: sugammadex |
| sugammadex and magnesium sulphate | Experimental | sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery Receives: Drug: Magnesium Sulphate; Drug: sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
TOF 0.9 Achieving Time
Measured: end of the surgery
Secondary outcomes (3)
Rocuronium Onset Time
Measured: during the surgery
Rocuronium Supplementation
Measured: during surgery
Postoperative Morphine Consumption
Measured: after 12 hour surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pre-eclampsia AggravatedStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Ipek ARSLAN, Kocaeli University
- Investigators
- Zehra I. ARSLAN, Asst. Prof., Principal investigator, Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972659
- Sponsor's protocol ID
- KOU 2012 KAEK 144
- Status last verified
- Jan 2014
- First submitted
- 11 Oct 2013
- Last updated
- 25 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients
- ClinicalTrials.gov ID
- NCT01972659
- Acronym / sponsor ID
- KOU 2012 KAEK 144
- Conditions
- Pre-eclampsia Aggravated
- Keywords
- sugammadex, rocuronium, magnesium, female
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Oct 2013 (estimated)
- Results
- Posted 25 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: The aim of this prospective study was to evaluate the effect of magnesium on the reversal of rocuronium-induced neuromuscular block by sugammadex.
Methods: Eighty patients, aged 18 to 60 years, American Society of Anesthesiologists I-II, undergoing elective gynecological surgery were enrolled. Anaesthesia was induced with propofol and fentanyl and was maintained with 60% nitrous oxide and Oxygen in sevoflurane. The magnesium group received 50 milligram/kilogram (mg/kg) Magnesium intravenous (iv) as a bolus and 15 mg/kg/hour by continuous infusion until the completion of surgery. The placebo group received the equivalent volume of isotonic saline. For intubation, 0.6 mg/kg rocuronium was administered and 0.1 mg/kg was added when Train of four (TOF) counts reached 1 or more during the procedure. At the end of the surgery at a TOF count of 1, 4 mg/kg sugammadex iv was administered. Patients were observed until a TOF ratio of 0.9 was achieved. Patient-controlled analgesia with intravenous morphine was used postoperatively.
Detailed description
Inclusion criteria:
- American Society of Anesthesiologists physical status I or II
- 18-60 years of age
- undergoing elective gynecological surgery
- requiring endotracheal intubation
Exclusion criteria:
- Patients who had body mass index > 35
- gastroesophageal reflux
- a history of allergy
- used medication known to interact with the drugs being used in this trial
- who experienced expected or unexpected difficulty during intubation or ventilation
- had neuromuscular disease
- hepatic or renal insufficiency
- pregnant
- were American Society of Anesthesiologists III or IV
- had a family history of malignant hyperthermia
- detection if low or high control plasma magnesium levels
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugammadex and placebo | Active comparator | Drug: placebo, Drug: sugammadexsugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery |
| sugammadex and magnesium sulphate | Experimental | Drug: Magnesium Sulphate, Drug: sugammadexsugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- female patients
- American Society of Anesthesiologists (ASA) physical status I or II
- 18-60 years of age who were undergoing elective gynecological surgery
- requiring endotracheal intubation were enrolled in this prospective study.
Key exclusion criteria (10 listed)
- Patients who had body mass index > 35
- gastroesophageal reflux
- a history of allergy
- used medication known to interact with the drugs being used in this trial
- who experienced expected or unexpected difficulty during intubation or ventilation
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 |
|---|---|---|
| placeboAlso: %0.9 NaCl, isotonic salineActive comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion | Drug | sugammadex and placebo |
| Magnesium SulphateAlso: magnesiumExperimental : 50 mg/kg bolus plus 15 mg/kg continuous infusion | Drug | sugammadex and magnesium sulphate |
| sugammadexAlso: bridion4 mg/kg iv bolus at the end of the surgery | Drug | sugammadex and magnesium sulphate, sugammadex and placebo |
Primary outcome
TOF 0.9 Achieving Time
Time frame: end of the surgery
3 secondary outcomes
Rocuronium Onset Time
Time frame: during the surgery
Rocuronium Supplementation
Time frame: during surgery
Postoperative Morphine Consumption
Time frame: after 12 hour surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Zehra I. ARSLAN, Asst. Prof. principal investigator
Anesthesiology and Reanimation
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 Magnesium Sulphate and sugammadex in people with Pre-eclampsia Aggravated, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 4 inclusion and 10 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 25 Feb 2014. 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 Turkey (Türkiye). 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?
Yes. Results are posted in the registry (first posted 25 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 0.9 Achieving Time (time frame: end of the 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 25 Feb 2014.