Muscle RelaxationPhase 2NCT02669368
Magnesium Sulfate Effects on Onset and Duration of Low Dose Rocuronium in Patients Undergoing Laparoscopic Cholecystectomy
A Phase 2 study testing Magnesium Sulfate, Saline and Standard dose Rocuronium in people with Muscle Relaxation, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Muscle Relaxation
- What is being tested?
- Magnesium Sulfate, Saline and Standard dose Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to Mar 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status 1 or 2.
- BMI of 25-34.9 kg/m2.
- Patients scheduled for laparoscopic cholecystectomy.
Who cannot join
- Severe respiratory or cardiac disease.
- Hepatic or renal function impairment.
- Neuromuscular disease.
- Patients on medications affecting neuromuscular function.
- Patients with known allergy to the drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Magnesium Sulfate on Onset and Duration of Low Dose Rocuronium in Patients Undergoing Laparoscopic Cholecystectomy
This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition in patients undergoing laparoscopic cholecystectomy.
- Conditions
- Muscle Relaxation
- Being tested
- Magnesium Sulfate, Saline, Standard dose Rocuronium, Low dose Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Patients in each group receive Magnesium sulfate 30 mg/kg in 0.9% normal saline (total volume 100 ml) intravenously for 5 min before induction of anesthesia
SalineDrug
Patients in each group receive 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia
Standard dose RocuroniumDrug
0.6 mg/kg of Rocuronium given with induction of anesthesia
Low dose RocuroniumDrug
0.45 mg/kg of Rocuronium given with induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Standard dose Rocuronium | Active comparator | Pretreatment of saline 100ml then giving Rocuronium 0.6 mg/kg at induction of anesthesia. Receives: Drug: Saline; Drug: Standard dose Rocuronium |
| Low dose Rocuronium | Active comparator | Pretreatment of saline 100ml then giving Rocuronium 0.45 mg/kg at induction of anesthesia. Receives: Drug: Saline; Drug: Low dose Rocuronium |
| Low dose Rocuronium + Magnesium Sulfate | Active comparator | Pretreatment of Magnesium sulfate 30 mg/kg then giving Rocuronium 0.45 mg/kg at induction of anesthesia. Receives: Drug: Magnesium Sulfate; Drug: Low dose Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of onset the action of Rocuronium
by using the TOF watch nerve stimulator
Measured: Time from injection of Rocuronium till T1 suppression more than 95% up to 10 minutes.
The time at which Maximal suppression
by using the TOF watch nerve stimulator
Measured: Time from the injection of Rocuronium to T1 maximal suppression time (TOF=0) up to an hour.
Reversal of Rocuronium
by using the TOF watch nerve stimulator
Measured: Time from injection of Rocuronium till reversal of T1 (TOF=25%) around an hour after induction of anesthesia
Secondary outcomes (2)
Intubation condition
to score intubation condition on the basis of 6 items: Jaw relaxation, laryngoscopy, vocal cord position, moving of limbs, coughing \& change in heart rate.
Measured: Within 10 minutes after induction of anesthesia
Surgical condition
to score a surgical condition according to 7 point likert scale
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle RelaxationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hamada Hamed, Assiut University
- Investigators
- Nawal Abdelaziz Gadelrab, Professor, Study chair, Assiut UniversityOla Mahmoud Wahba, Lecturer, Study director, Assiut University HospitalsAhmed Hamada Hamed Amin, Resident, Principal investigator, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669368
- Sponsor's protocol ID
- 01MgRo
- Status last verified
- Jan 2016
- First submitted
- 25 Jan 2016
- Last updated
- 1 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnesium Sulfate on Onset and Duration of Low Dose Rocuronium in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT02669368
- Acronym / sponsor ID
- 01MgRo
- Conditions
- Muscle Relaxation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- First posted
- 1 Feb 2016 (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.
This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition in patients undergoing laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard dose Rocuronium | Active comparator | Drug: Saline, Drug: Standard dose RocuroniumPretreatment of saline 100ml then giving Rocuronium 0.6 mg/kg at induction of anesthesia. |
| Low dose Rocuronium | Active comparator | Drug: Saline, Drug: Low dose RocuroniumPretreatment of saline 100ml then giving Rocuronium 0.45 mg/kg at induction of anesthesia. |
| Low dose Rocuronium + Magnesium Sulfate | Active comparator | Drug: Magnesium Sulfate, Drug: Low dose RocuroniumPretreatment of Magnesium sulfate 30 mg/kg then giving Rocuronium 0.45 mg/kg at induction of anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status 1 or 2.
- BMI of 25-34.9 kg/m2.
- Patients scheduled for laparoscopic cholecystectomy.
Key exclusion criteria (5 listed)
- Severe respiratory or cardiac disease.
- Hepatic or renal function impairment.
- Neuromuscular disease.
- Patients on medications affecting neuromuscular function.
- Patients with known allergy to the drugs.
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 |
|---|---|---|
| Magnesium SulfatePatients in each group receive Magnesium sulfate 30 mg/kg in 0.9% normal saline (total volume 100 ml) intravenously for 5 min before induction of anesthesia | Drug | Low dose Rocuronium + Magnesium Sulfate |
| SalinePatients in each group receive 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia | Drug | Low dose Rocuronium, Standard dose Rocuronium |
| Standard dose Rocuronium0.6 mg/kg of Rocuronium given with induction of anesthesia | Drug | Standard dose Rocuronium |
| Low dose Rocuronium0.45 mg/kg of Rocuronium given with induction of anesthesia | Drug | Low dose Rocuronium, Low dose Rocuronium + Magnesium Sulfate |
Primary outcome
The time of onset the action of Rocuronium
Time frame: Time from injection of Rocuronium till T1 suppression more than 95% up to 10 minutes.
by using the TOF watch nerve stimulator
The time at which Maximal suppression
Time frame: Time from the injection of Rocuronium to T1 maximal suppression time (TOF=0) up to an hour.
by using the TOF watch nerve stimulator
Reversal of Rocuronium
Time frame: Time from injection of Rocuronium till reversal of T1 (TOF=25%) around an hour after induction of anesthesia
by using the TOF watch nerve stimulator
2 secondary outcomes
Intubation condition
Time frame: Within 10 minutes after induction of anesthesia
Surgical condition
Time frame: During surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
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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.
Nawal Abdelaziz Gadelrab, Professor study chair
Assiut University
Ola Mahmoud Wahba, Lecturer study director
Assiut University Hospitals
Ahmed Hamada Hamed Amin, Resident principal investigator
Assiut University Hospitals
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 Magnesium Sulfate, Saline and Standard dose Rocuronium in people with Muscle Relaxation, run by Assiut University at 1 site in Egypt.
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 5 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 1 Feb 2016. 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 Egypt. 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?
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?
The time of onset the action of Rocuronium (time frame: Time from injection of Rocuronium till T1 suppression more than 95% up to 10 minutes.). The study lists 3 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 1 Feb 2016.