Shivering ControlPhase 3NCT04695613
Shivering Control After Percutaneous Nephrolithotomy
A Phase 3 study testing Aminoacid and Magnesium sulfate in people with Shivering Control, run by Assiut University at 1 site in Egypt.
Trial summary
Aim of the study is comparing the effect of amino acid versus magnesium sulfate infusion on postoperative shivering in patients undergoing elective percutaneous nephrolithotomy surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shivering Control
- What is being tested?
- Aminoacid and Magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2021to 10 Apr 2021
- Phase
- Phase 3
- 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
- ASA I-II who were listed for elective percutaneous nephrolithotomy PCNL surgery under general anesthesia.
Who cannot join
- Hepatic inefficiency
- Renal inefficiency
- Spinal anesthesia because of a different mechanism of hypothermia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Amino Acids Versus Magnesium Sulphate Infusion in Controlling Postoperative Shivering
Aim of the study is comparing the effect of amino acid versus magnesium sulfate infusion on postoperative shivering in patients undergoing elective percutaneous nephrolithotomy surgery under general anesthesia.
Read the detailed description
A written informed consent was taken from the patients. Patients were assigned randomly to two groups (40 subjects each) to be anesthetized and infused with either an iv amino acid starting just before and during anesthesia (group A) or an iv magnesium sulphate starting just before and during anesthesia (group M) in the perioperative period.
- Conditions
- Shivering Control
- Being tested
- Aminoacid, Magnesium sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AminoacidDrug
amino acid infusion 150 ml/kg/hr starting preoperative
Magnesium sulfateDrug
magnesium sulphate bolus and infusion 60 mg/kg starting preoperative
| Study group | Role | What they receive |
|---|---|---|
| aminoacid group | Active comparator | patients received an IV amino acid infusion 150 ml/kg/hr starting just before and during anesthesia Receives: Drug: Aminoacid |
| magnesium sulfate group | Active comparator | patients received an IV magnesium sulphate bolus and infusion 40 mg/kg starting just before and during anesthesia Receives: Drug: Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative shivering grade
"grading of shivering," in which shivering degree was assessed as 1 of 5 levels (0, 1, 2, 3, and 4), grade 0 lack of shivering, grade 1 slight shivering (inconsiderable yet apparent peripheral vasoconstriction), grade 2 medium level shivering (muscular activity in one muscle group only) grade 3 severe shivering (muscular activity in more than one muscle group without generalized shivering) and grade 4 generalized shivering.
Measured: 2 hours postoperative
Secondary outcomes (2)
Shivering frequency
Number of shivering episodes in postoperative period
Measured: 2 hours postoperative
Blood loss volume
Assessing blood loss in surgical drains postoperative
Measured: 2 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start3 Jan 2021
- Primary completion25 Mar 2021
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shivering ControlStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Makram Soliman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695613
- Sponsor's protocol ID
- 17300539
- Status last verified
- May 2021
- First submitted
- 3 Jan 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amino Acids Versus Magnesium Sulphate Infusion in Controlling Postoperative Shivering
- ClinicalTrials.gov ID
- NCT04695613
- Acronym / sponsor ID
- 17300539
- Conditions
- Shivering Control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 5 Jan 2021 (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.
Aim of the study is comparing the effect of amino acid versus magnesium sulfate infusion on postoperative shivering in patients undergoing elective percutaneous nephrolithotomy surgery under general anesthesia.
Detailed description
A written informed consent was taken from the patients. Patients were assigned randomly to two groups (40 subjects each) to be anesthetized and infused with either an iv amino acid starting just before and during anesthesia (group A) or an iv magnesium sulphate starting just before and during anesthesia (group M) in the perioperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aminoacid group | Active comparator | Drug: Aminoacidpatients received an IV amino acid infusion 150 ml/kg/hr starting just before and during anesthesia |
| magnesium sulfate group | Active comparator | Drug: Magnesium sulfatepatients received an IV magnesium sulphate bolus and infusion 40 mg/kg starting just before and during anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-II who were listed for elective percutaneous nephrolithotomy PCNL surgery under general anesthesia.
Key exclusion criteria (3 listed)
- Hepatic inefficiency
- Renal inefficiency
- Spinal anesthesia because of a different mechanism of hypothermia
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 |
|---|---|---|
| Aminoacidamino acid infusion 150 ml/kg/hr starting preoperative | Drug | aminoacid group |
| Magnesium sulfatemagnesium sulphate bolus and infusion 60 mg/kg starting preoperative | Drug | magnesium sulfate group |
Primary outcome
Postoperative shivering grade
Time frame: 2 hours postoperative
"grading of shivering," in which shivering degree was assessed as 1 of 5 levels (0, 1, 2, 3, and 4), grade 0 lack of shivering, grade 1 slight shivering (inconsiderable yet apparent peripheral vasoconstriction), grade 2 medium level shivering (muscular activity in one muscle group only) grade 3 severe shivering (muscular activity in more than one muscle group without generalized shivering) and grade 4 generalized shivering.
2 secondary outcomes
Shivering frequency
Time frame: 2 hours postoperative
Blood loss volume
Time frame: 2 hours postoperative
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 1 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aminoacid and Magnesium sulfate in people with Shivering Control, 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 1 inclusion and 3 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 1 Jun 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Postoperative shivering grade (time frame: 2 hours postoperative). 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 Jun 2021.