Prevention of Postspinal ShiveringPhase 4NCT04249804
the Use of Magnesium Sulfate for Prevention of Postspinal Shivering
A Phase 4 study testing Magnesium Sulfate 1000 MG in people with Prevention of Postspinal Shivering, run by Cairo University at 1 site in Egypt.
Trial summary
Shivering is an unpleasant experience after spinal anesthesia. Shivering is defined as an involuntary, repetitive activity of skeletal muscles. The mechanisms of shivering in patients undergoing surgery are mainly intraoperative heat loss, increased sympathetic tone, pain, and systemic release of pyrogens. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Postspinal Shivering
- What is being tested?
- Magnesium Sulfate 1000 MG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2020to 3 Jun 2020
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20-45 years old
- Both genders
- ASA I, II
Who cannot join
- Patients with hemodynamic instability
- cardiopulmonary
- renal , liver disease
- hypo or hyperthyroidism
- cerebrovascular insufficiency
- coagulation defects
Show all 14Show fewer
- those with psychiatric disorder
- patients receiving vasoactive drugs or beta blockers
- BMI > 35
- allergic to study drug
- height <160 cm or >190 cm
- basal body temperature >38°C or <36°C
- those who received blood transfusion or >2000 mL fluid intra-operatively
- surgery duration > 3 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Infusion Versus Intrathecal Injection of Magnesium Sulfate for Prevention of Postspinal Shivering During Lower Limb Fracture Surgery. A Randomized Comparative Study
Shivering is an unpleasant experience after spinal anesthesia. Shivering is defined as an involuntary, repetitive activity of skeletal muscles. The mechanisms of shivering in patients undergoing surgery are mainly intraoperative heat loss, increased sympathetic tone, pain, and systemic release of pyrogens. Spinal anesthesia significantly impairs the thermoregulation system by inhibiting tonic vasoconstriction, which plays a significant role in temperature regulation. Spinal anesthesia also causes redistribution of core heat from the trunk (below the block level) to the peripheral tissues. These two effects predispose patients to hypothermia and shivering. The median incidence of shivering related to regional anesthesia observed in a review of 21 studies is 64.4%. Shivering increases oxygen consumption, lactic acidosis, carbon dioxide production, and metabolic rate by up to 400%. Therefore, shivering may cause problems in patients with low cardiac and pulmonary reserves. The best way to avoid these intraoperative and postoperative shivering-induced increases in hemodynamic and metabolic demands is to prevent shivering in the first place. Although magnesium is among several pharmacological agents used for the treatment of shivering, its effects on prevention of shivering during central neuraxial blockade have not been evaluated to date. Henceforth, the aim of this study was to evaluate the effect of magnesiume on shivering during spinal anesthesia.
Aim:
to compare the efficacy of intravenous versus intrathecal magnesium sulphate for prevention of post spinal shivering in adult patients undergoing elective lower limb orthopedic surgeries.
- Conditions
- Prevention of Postspinal Shivering
- Being tested
- Magnesium Sulfate 1000 MG
- Keywords
- Magnesium Sulfate - postspinal shivering -intrathecal - infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate 1000 MGDrug
intrathecal versus IV infusion of Magnesium sulfate for prevention of postspinal shivering
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Mg group | Experimental | 45 patients will receive 50 mg intrathecal MgSo4 added to 0.5% hyperbaric bupivacaine Receives: Drug: Magnesium Sulfate 1000 MG |
| IV Mg infusion group | Experimental | 45 patients will receive IV magnesium sulfate 50 mg/kg in 100 mL isotonic saline over 20 min as a bolus then 2 mg/kg/h infusion using a separate infusion set after administering spinal anesthesia Receives: Drug: Magnesium Sulfate 1000 MG |
| control | No intervention | 0.5% heavy bupivacaine in the spinal with no additives |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postspinal shivering
the efficacy of the use of MgSo4 IV infusion versus intrathecal injection in decreasing the incidence of postspinal shivering using Crossley and Mahajan scale which is 0, no shivering; 1, piloerection or peripheral vasoconstriction (cyanosis) but no visible shivering; 2, muscular activity in only one muscle group; 3, muscular activity in more than one muscle group but not generalized shivering; and 4, shivering involving the whole body
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start15 Jan 2020
- Primary completion1 Jun 2020
- Study completion3 Jun 2020
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 Prevention of Postspinal ShiveringStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomly allocated to Groups (\[T\], Intrathecal MgSo4 and \[M\], IV infusion MgSo4 groups) on the basis of computer-generated random numbers. Patients belonging to Group T (n = 45) will receive 50 mg intrathecal MgSo4 added to 0.5% hyperbaric bupivacaine \[131\],while those belonging to Group M (group, n = 45) will receive IV magnesium sulfate 50 mg/kg in 100 mL isotonic saline over 20 min as a bolus then 2 mg/kg/h infusion using a separate infusion set after administering spinal anesthesia. Axillary temperature and grades of shivering will be noted every 10 min by the same anesthesiologist who performed the spinal anesthesia using Crossley and Mahajan scale,\[8\] If grade III, IV shivering persisted for \>10 min pethidine 25 mg IV will be administered as a rescue drug and number of patients required rescue drug will be recorded.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Abdullah Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249804
- Sponsor's protocol ID
- MS-261-2019
- Status last verified
- Aug 2020
- First submitted
- 28 Jan 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
1. Frank S.M., Higgins M.S., Breslow M.J., et al. The catecholamine, cortisol, and hemodynamic responses to mild perioperative hypothermia: a randomized clinical trial Anesthesiology,1995, 82:83-93. 2. Crowley LJ, Buggy DJ .Shivering and neuraxial anesthesia.Reg Anesth Pain Med. 2008 May-Jun;33(3):241-52. doi: 10.1016/j.rapm.2007.11.006. 3. Mizobe T., Nakajima Y., Sunaguchi M., et al.Clonidine produces a dose-dependant impairment of baroreflex-mediated thermoregulatory responses to positive end-expiratory pressure in anesthetized humans.BJA, 2005, 94:536-541 4. Witte J. De, Sessler D.I.Perioperative shivering: physiology and pharmacology.Anesthesiology, 2002,96:467-484 5. Eberhart LH, Döderlein F, Eisenhardt G, et al Independent risk factors for postoperative shivering. Anesth Analg,2005, 101:1849-1857. 6. Lyons B, Power C, Casey W.Postanaesthesia shivering in children. Anaesthesia 1996.51: 442-445. 7. Hull D, Smales . Heat production in the newborn. In: Sinclair JC (eds.) Temperature Regulation and Energy Metabolism in the Newborn. Grune& Stratton, New York.1978 46:129-156 8. Crossley AW, Mahajan RP. The intensity of postoperative shivering is unrelated to axillary temperature. Anaesthesia 1994,49:205-207 9. P. Kranke, L.H. Eberhart, N. Roewer, M.R. TramerSingle-dose parenteral pharmacological interventions for the prevention of postoperative shivering: a quantitative systematic review of randomized controlled trials Anesth Analg, 2004, 99 :718-727 10. T. Ikeda, T. Kazama, D.I. Sessler, et al.Induction of anesthesia with ketamine reduces the magnitude of redistribution hypothermia.Anesth Analg, 2001,93: 934-938 11. S. Kizilirmak, S.E. Karakas, O. Akca, et al.Magnesium sulfate stops postanesthetic shivering.Ann NY Acad Sci, 1997813: 799-806 12. R.M. Zweifler, M.E. Voorhees, M.A. Mahmood, M. Parnell.Magnesium sulfate increases the rate of hypothermia via surface cooling and improves comfort.Stroke, 2004,35:2331-2334 13. D.B. Cotton, M. Hallak, C. Janusz, S.M. Irtenkauf, R.F. BermanCentral anticonvulsant effects of magnesium sulfate on N-methyl-D-aspartate-induced seizures.Am J Obstet Gynecol, 1993,168:974-978 14. C. Lee, X. Zhang, W.F. Kwan.Electromyographic and mechanomyographic characteristics of neuromuscular block by magnesium sulphate in the pig.Br J Anaesth, 1996,76:278-283 15. V. Rukshin, P.K. Shah, B. Cercek, A. Finkelstein, V. Tsang, S. Kaul.Comparative antithrombotic effects of magnesium sulfate and the platelet glycoprotein IIb/IIIa inhibitors tirofiban and eptifibatide in a canine model of stent thrombosis.Circulation, 2002,105:1970-1975 16. Gozdemir M, Usta B, Demircioglu RI, Muslu B, Sert H, Karatas OF. Magnesium sulfate infusion prevents shivering during transurethral prostatectomy with spinal anesthesia: a randomized, double-blinded, controlled study. J Clin Anesth. 2010,22:184-189.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Infusion Versus Intrathecal Injection of Magnesium Sulfate for Prevention of Postspinal Shivering During Lower Limb Fracture Surgery. A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT04249804
- Acronym / sponsor ID
- MS-261-2019
- Conditions
- Prevention of Postspinal Shivering
- Keywords
- Magnesium Sulfate - postspinal shivering -intrathecal - infusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 31 Jan 2020 (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.
Shivering is an unpleasant experience after spinal anesthesia. Shivering is defined as an involuntary, repetitive activity of skeletal muscles. The mechanisms of shivering in patients undergoing surgery are mainly intraoperative heat loss, increased sympathetic tone, pain, and systemic release of pyrogens. Spinal anesthesia significantly impairs the thermoregulation system by inhibiting tonic vasoconstriction, which plays a significant role in temperature regulation. Spinal anesthesia also causes redistribution of core heat from the trunk (below the block level) to the peripheral tissues. These two effects predispose patients to hypothermia and shivering. The median incidence of shivering related to regional anesthesia observed in a review of 21 studies is 64.4%. Shivering increases oxygen consumption, lactic acidosis, carbon dioxide production, and metabolic rate by up to 400%. Therefore, shivering may cause problems in patients with low cardiac and pulmonary reserves. The best way to avoid these intraoperative and postoperative shivering-induced increases in hemodynamic and metabolic demands is to prevent shivering in the first place. Although magnesium is among several pharmacological agents used for the treatment of shivering, its effects on prevention of shivering during central neuraxial blockade have not been evaluated to date. Henceforth, the aim of this study was to evaluate the effect of magnesiume on shivering during spinal anesthesia.
Aim:
to compare the efficacy of intravenous versus intrathecal magnesium sulphate for prevention of post spinal shivering in adult patients undergoing elective lower limb orthopedic surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The patients will be randomly allocated to Groups ([T], Intrathecal MgSo4 and [M], IV infusion MgSo4 groups) on the basis of computer-generated random numbers. Patients belonging to Group T (n = 45) will receive 50 mg intrathecal MgSo4 added to 0.5% hyperbaric bupivacaine [131],while those belonging to Group M (group, n = 45) will receive IV magnesium sulfate 50 mg/kg in 100 mL isotonic saline over 20 min as a bolus then 2 mg/kg/h infusion using a separate infusion set after administering spinal anesthesia. Axillary temperature and grades of shivering will be noted every 10 min by the same anesthesiologist who performed the spinal anesthesia using Crossley and Mahajan scale,[8] If grade III, IV shivering persisted for >10 min pethidine 25 mg IV will be administered as a rescue drug and number of patients required rescue drug will be recorded.
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Mg group | Experimental | Drug: Magnesium Sulfate 1000 MG45 patients will receive 50 mg intrathecal MgSo4 added to 0.5% hyperbaric bupivacaine |
| IV Mg infusion group | Experimental | Drug: Magnesium Sulfate 1000 MG45 patients will receive IV magnesium sulfate 50 mg/kg in 100 mL isotonic saline over 20 min as a bolus then 2 mg/kg/h infusion using a separate infusion set after administering spinal anesthesia |
| control | No intervention | –0.5% heavy bupivacaine in the spinal with no additives |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 20-45 years old
- Both genders
- ASA I, II
Key exclusion criteria (14 listed)
- Patients with hemodynamic instability
- cardiopulmonary
- renal , liver disease
- hypo or hyperthyroidism
- cerebrovascular insufficiency
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 Sulfate 1000 MGintrathecal versus IV infusion of Magnesium sulfate for prevention of postspinal shivering | Drug | IV Mg infusion group, Intrathecal Mg group |
Primary outcome
incidence of postspinal shivering
Time frame: up to 5 months
the efficacy of the use of MgSo4 IV infusion versus intrathecal injection in decreasing the incidence of postspinal shivering using Crossley and Mahajan scale which is 0, no shivering; 1, piloerection or peripheral vasoconstriction (cyanosis) but no visible shivering; 2, muscular activity in only one muscle group; 3, muscular activity in more than one muscle group but not generalized shivering; and 4, shivering involving the whole body
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 6 Aug 2020.
- Background1. Frank S.M., Higgins M.S., Breslow M.J., et al. The catecholamine, cortisol, and hemodynamic responses to mild perioperative hypothermia: a randomized clinical trial Anesthesiology,1995, 82:83-93. 2. Crowley LJ, Buggy DJ .Shivering and neuraxial anesthesia.Reg Anesth Pain Med. 2008 May-Jun;33(3):241-52. doi: 10.1016/j.rapm.2007.11.006. 3. Mizobe T., Nakajima Y., Sunaguchi M., et al.Clonidine produces a dose-dependant impairment of baroreflex-mediated thermoregulatory responses to positive end-expiratory pressure in anesthetized humans.BJA, 2005, 94:536-541 4. Witte J. De, Sessler D.I.Perioperative shivering: physiology and pharmacology.Anesthesiology, 2002,96:467-484 5. Eberhart LH, Döderlein F, Eisenhardt G, et al Independent risk factors for postoperative shivering. Anesth Analg,2005, 101:1849-1857. 6. Lyons B, Power C, Casey W.Postanaesthesia shivering in children. Anaesthesia 1996.51: 442-445. 7. Hull D, Smales . Heat production in the newborn. In: Sinclair JC (eds.) Temperature Regulation and Energy Metabolism in the Newborn. Grune& Stratton, New York.1978 46:129-156 8. Crossley AW, Mahajan RP. The intensity of postoperative shivering is unrelated to axillary temperature. Anaesthesia 1994,49:205-207 9. P. Kranke, L.H. Eberhart, N. Roewer, M.R. TramerSingle-dose parenteral pharmacological interventions for the prevention of postoperative shivering: a quantitative systematic review of randomized controlled trials Anesth Analg, 2004, 99 :718-727 10. T. Ikeda, T. Kazama, D.I. Sessler, et al.Induction of anesthesia with ketamine reduces the magnitude of redistribution hypothermia.Anesth Analg, 2001,93: 934-938 11. S. Kizilirmak, S.E. Karakas, O. Akca, et al.Magnesium sulfate stops postanesthetic shivering.Ann NY Acad Sci, 1997813: 799-806 12. R.M. Zweifler, M.E. Voorhees, M.A. Mahmood, M. Parnell.Magnesium sulfate increases the rate of hypothermia via surface cooling and improves comfort.Stroke, 2004,35:2331-2334 13. D.B. Cotton, M. Hallak, C. Janusz, S.M. Irtenkauf, R.F. BermanCentral anticonvulsant effects of magnesium sulfate on N-methyl-D-aspartate-induced seizures.Am J Obstet Gynecol, 1993,168:974-978 14. C. Lee, X. Zhang, W.F. Kwan.Electromyographic and mechanomyographic characteristics of neuromuscular block by magnesium sulphate in the pig.Br J Anaesth, 1996,76:278-283 15. V. Rukshin, P.K. Shah, B. Cercek, A. Finkelstein, V. Tsang, S. Kaul.Comparative antithrombotic effects of magnesium sulfate and the platelet glycoprotein IIb/IIIa inhibitors tirofiban and eptifibatide in a canine model of stent thrombosis.Circulation, 2002,105:1970-1975 16. Gozdemir M, Usta B, Demircioglu RI, Muslu B, Sert H, Karatas OF. Magnesium sulfate infusion prevents shivering during transurethral prostatectomy with spinal anesthesia: a randomized, double-blinded, controlled study. J Clin Anesth. 2010,22:184-189.
- Individual participant dataSharing planned: Yes
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 4 study testing Magnesium Sulfate 1000 MG in people with Prevention of Postspinal Shivering, run by Cairo 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 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: finished, as of the sponsor's last update on 6 Aug 2020. 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 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?
incidence of postspinal shivering (time frame: up to 5 months). 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 NCT04249804, 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 6 Aug 2020.