Post Spinal Anesthesia ShiveringNCT06999070
The Effect of Different Doses of Dexamethasone on Post Spinal Anesthesia Shivering
A study testing Dexamethasone 0.1mg/kg and Dexamethasone 0.3mg/kg in people with Post Spinal Anesthesia Shivering, run by Assiut University.
Trial summary
The precise etiology of post-spinal anesthesia shivering (PSAS) is not fully understood. The incidence ranges between 20 to 80%. Heat loss, reduced sympathetic tone and pyrogen release are termed as the main causes of intra/postoperative shivering. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Spinal Anesthesia Shivering
- What is being tested?
- Dexamethasone 0.1mg/kg and Dexamethasone 0.3mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA physical status I-II.
- Both sexes.
- Age: 21-55 years old.
- Scheduled for lower limb orthopedic surgery.
- BMI less than 35 kg/m2.
Who cannot join
- ASA physical status more than II.
- History of corticosteroid therapy or allergic reaction to any of the medication used in the study
- Patients with cognitive impairment.
- Pregnancy.
- Basal body temperatures of more than 38° or less than 36° C.
- BMI more than 35 kg/m2.
About this study
Official title: A Randomized, Comparative Study of Different Doses of Intravenous Dexamethasone for Management of Post Spinal Anesthesia Shivering in Lower Limb Orthopedic Surgeries
The precise etiology of post-spinal anesthesia shivering (PSAS) is not fully understood. The incidence ranges between 20 to 80%. Heat loss, reduced sympathetic tone and pyrogen release are termed as the main causes of intra/postoperative shivering.
The redistribution of heat from the core to the periphery of the body is facilitated by the vasodilatation associated with neuraxial anesthesia. Shivering causes tachycardia, lactic acidosis, hyperalgesia at the site of surgery, releases catecholamines, increases oxygen demand, and increases the risk of hypoxemia. [1][3] The most common causes of shivering include fever, shivering with spinal anesthesia movement disorders, post-anesthetic shivering, fear, excitement, stress, tremors, low blood sugar, anxiety, and shivering. Shivering with spinal anesthesia is an involuntary, oscillatory muscular activity that significantly increases metabolic heat production, potentially reaching up to 600% above the basal metabolic level.
Read more
Post-spinal shivering is one of the main sources of discomfort for patients recovering from surgery. Furthermore, it worsens wound pain and impedes electrocardiographic monitoring.
Prophylactic intravenous administration of dexamethasone has been currently used for controlling intra-operative and post spinal anesthesia shivering. Dexamethasone's anti-inflammatory effects may thereby lessen post-anesthesia shivering by reducing the gradient between skin and core body temperatures.
Read the detailed description
Preoperative preparation:
All patients will be assessed preoperatively by history, physical examination, basal laboratory investigations (complete blood picture and INR) and electrocardiography (ECG). The anesthetic procedure will be explained to the patients and written informed consent will be signed. Preoperative preparations included fasting for 68 h before the surgery. No premedication was given to the patients prior to the surgery. On arrival of the patient in the operating room, heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure (MAP), peripheral oxygen saturation (SpO2) and temperature will be recorded. A peripheral IV access will be obtained using an 18G venous cannula. IV fluids of normal room temperature will be given. No other warming device will be used. Lactated Ringers infused at 10 mL/kg/h over 30 min just before spinal anesthesia is administered. The infusion rate will be given as need till the end of surgery. Spinal anesthesia will be instituted at L34 or L 45 with patient in setting position with 2.5-4 mL (12.5-20 mg) of bupivacaine (heavy) 0.5% using a 25G Quinckes spinal needle. The level of sensory block will be assessed after intrathecal injection after 15 minutes.
Intraoperative management:
Standard (ASA) monitoring will be applied before anesthesia and monitored throughout the operation time Treatment of complications if occurred as: hypotension (defined as any decrease in mean arterial blood pressure (MAP) below 20% of the baseline or systolic pressure less than 90 mmHg) will be treated with a bolus of ephedrine (6-12 mg) I.V. Bradycardia (defined as decreased heart rate (HR) ≥ 20% compared to the baseline values) will be treated with 0.1 mg/kg IV atropine. Failed block or inadequate block (patient complains of pain in the intraoperative period), he/she will be given general anesthesia and will be excluded from the study.
The incidence and onset of PSAS were recorded, and Bedside Shivering Assessment Scale (BSAS) was used to grade the severity:
Grade 1 (zero points): No shivering Grade 2 (1 point): mild shivering that is limited to the neck and thorax may not be detected and may only be detected by palpation or as an artefact on ECG Grade 3 (2 points): Moderate: Intermittent upper extremity involvement plus/minus thorax Grade 4 (3 points): Severe: prolonged trembling of the upper or lower extremities or widespread shivering.
-The drug will be intravenously injected to the patients after the detection of shivering : Group A will take Dexamethasone 0.1 mg/kg Group B will take Dexamethasone 0.3 mg/kg. Monitoring the effect of the drug on shivering offset.
Postoperative Treatments:
At the end of the surgery, the patients will be transferred to the PACU. Patients will be kept in 45°C setting. Follow up the patient for 60 minutes (HR, SO2, BP and PSAS).
- Conditions
- Post Spinal Anesthesia Shivering
- Being tested
- Dexamethasone 0.1mg/kg, Dexamethasone 0.3mg/kg
- Keywords
- Dexamethasone, Post spinal anesthesia shivering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 0.1mg/kgDrug
On incidence of Shivering after spinal anaethesia
Dexamethasone 0.3mg/kgDrug
On incidence of Shivering after spinal anaethesia
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients will take 0.1 mg/kg dexamethasone iv on incidence of Shivering after spinal anaethesia Receives: Drug: Dexamethasone 0.1mg/kg |
| Group B | Active comparator | patients will take Dexamethasone 0.3 mg/kg intravenously injected to the patients after the detection of shivering Receives: Drug: Dexamethasone 0.3mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of PSAS
Bedside Shivering Assessment Scale (BSAS) was used to grade the severity:
Grade 1 (zero points): No shivering Grade 2 (1 point): mild shivering that is limited to the neck and thorax may not be detected and may only be detected by palpation or as an artefact on ECG Grade 3 (2 points): Moderate: Intermittent upper extremity involvement plus/minus thorax Grade 4 (3 points): Severe: prolonged trembling of the upper or lower extremities or widespread shivering.
Measured: 60 minutes after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study startMay 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Spinal Anesthesia ShiveringStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nader Ahmed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999070
- Sponsor's protocol ID
- Dexamethasone and shivering
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 31 May 2025
- 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 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Comparative Study of Different Doses of Intravenous Dexamethasone for Management of Post Spinal Anesthesia Shivering in Lower Limb Orthopedic Surgeries
- ClinicalTrials.gov ID
- NCT06999070
- Acronym / sponsor ID
- Dexamethasone and shivering
- Conditions
- Post Spinal Anesthesia Shivering
- Keywords
- Dexamethasone, Post spinal anesthesia shivering
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 31 May 2025 (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.
The precise etiology of post-spinal anesthesia shivering (PSAS) is not fully understood. The incidence ranges between 20 to 80%. Heat loss, reduced sympathetic tone and pyrogen release are termed as the main causes of intra/postoperative shivering.
The redistribution of heat from the core to the periphery of the body is facilitated by the vasodilatation associated with neuraxial anesthesia. Shivering causes tachycardia, lactic acidosis, hyperalgesia at the site of surgery, releases catecholamines, increases oxygen demand, and increases the risk of hypoxemia. [1][3] The most common causes of shivering include fever, shivering with spinal anesthesia movement disorders, post-anesthetic shivering, fear, excitement, stress, tremors, low blood sugar, anxiety, and shivering. Shivering with spinal anesthesia is an involuntary, oscillatory muscular activity that significantly increases metabolic heat production, potentially reaching up to 600% above the basal metabolic level.
Post-spinal shivering is one of the main sources of discomfort for patients recovering from surgery. Furthermore, it worsens wound pain and impedes electrocardiographic monitoring.
Prophylactic intravenous administration of dexamethasone has been currently used for controlling intra-operative and post spinal anesthesia shivering. Dexamethasone's anti-inflammatory effects may thereby lessen post-anesthesia shivering by reducing the gradient between skin and core body temperatures.
Detailed description
Preoperative preparation:
All patients will be assessed preoperatively by history, physical examination, basal laboratory investigations (complete blood picture and INR) and electrocardiography (ECG). The anesthetic procedure will be explained to the patients and written informed consent will be signed. Preoperative preparations included fasting for 68 h before the surgery. No premedication was given to the patients prior to the surgery. On arrival of the patient in the operating room, heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure (MAP), peripheral oxygen saturation (SpO2) and temperature will be recorded. A peripheral IV access will be obtained using an 18G venous cannula. IV fluids of normal room temperature will be given. No other warming device will be used. Lactated Ringers infused at 10 mL/kg/h over 30 min just before spinal anesthesia is administered. The infusion rate will be given as need till the end of surgery. Spinal anesthesia will be instituted at L34 or L 45 with patient in setting position with 2.5-4 mL (12.5-20 mg) of bupivacaine (heavy) 0.5% using a 25G Quinckes spinal needle. The level of sensory block will be assessed after intrathecal injection after 15 minutes.
Intraoperative management:
Standard (ASA) monitoring will be applied before anesthesia and monitored throughout the operation time Treatment of complications if occurred as: hypotension (defined as any decrease in mean arterial blood pressure (MAP) below 20% of the baseline or systolic pressure less than 90 mmHg) will be treated with a bolus of ephedrine (6-12 mg) I.V. Bradycardia (defined as decreased heart rate (HR) ≥ 20% compared to the baseline values) will be treated with 0.1 mg/kg IV atropine. Failed block or inadequate block (patient complains of pain in the intraoperative period), he/she will be given general anesthesia and will be excluded from the study.
The incidence and onset of PSAS were recorded, and Bedside Shivering Assessment Scale (BSAS) was used to grade the severity:
Grade 1 (zero points): No shivering Grade 2 (1 point): mild shivering that is limited to the neck and thorax may not be detected and may only be detected by palpation or as an artefact on ECG Grade 3 (2 points): Moderate: Intermittent upper extremity involvement plus/minus thorax Grade 4 (3 points): Severe: prolonged trembling of the upper or lower extremities or widespread shivering.
-The drug will be intravenously injected to the patients after the detection of shivering : Group A will take Dexamethasone 0.1 mg/kg Group B will take Dexamethasone 0.3 mg/kg. Monitoring the effect of the drug on shivering offset.
Postoperative Treatments:
At the end of the surgery, the patients will be transferred to the PACU. Patients will be kept in 45°C setting. Follow up the patient for 60 minutes (HR, SO2, BP and PSAS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Dexamethasone 0.1mg/kgPatients will take 0.1 mg/kg dexamethasone iv on incidence of Shivering after spinal anaethesia |
| Group B | Active comparator | Drug: Dexamethasone 0.3mg/kgpatients will take Dexamethasone 0.3 mg/kg intravenously injected to the patients after the detection of shivering |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ASA physical status I-II.
- Both sexes.
- Age: 21-55 years old.
- Scheduled for lower limb orthopedic surgery.
- BMI less than 35 kg/m2.
Key exclusion criteria (6 listed)
- ASA physical status more than II.
- History of corticosteroid therapy or allergic reaction to any of the medication used in the study
- Patients with cognitive impairment.
- Pregnancy.
- Basal body temperatures of more than 38° or less than 36° C.
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 |
|---|---|---|
| Dexamethasone 0.1mg/kgOn incidence of Shivering after spinal anaethesia | Drug | Group A |
| Dexamethasone 0.3mg/kgOn incidence of Shivering after spinal anaethesia | Drug | Group B |
Primary outcome
severity of PSAS
Time frame: 60 minutes after operation
Bedside Shivering Assessment Scale (BSAS) was used to grade the severity: Grade 1 (zero points): No shivering Grade 2 (1 point): mild shivering that is limited to the neck and thorax may not be detected and may only be detected by palpation or as an artefact on ECG Grade 3 (2 points): Moderate: Intermittent upper extremity involvement plus/minus thorax Grade 4 (3 points): Severe: prolonged trembling of the upper or lower extremities or widespread shivering.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Mohamed Medhat Moustafa Kamal Nouh, Galal Adel Mohamed Abd Elrehiem Elkadi, Eman Mohamed Kamal Aboseif, Fasil Said Abd El Hamid, Marwa Mostafa Mohamed Ali Mowafi. A randomized, comparative study of prophylactic intravenous acetaminophen, dexamethasone anLink provided by the sponsor.
- Adel Rizk Botros, Yasser M. Nasr, Wafaa Ibrahim Abd el Wahid Khalil. Comparative study between dexamethasone and ondansetron for prevention ofshivering during spinal anaethesia.Link provided by the sponsor.
- Hunde Amsalu, Abebayehu Zemedkun, Teshome Ragasa, Yayeh Adamu. Evidence-Based Guideline on Prevention and Management of Shivering After Spinal Anesthesia in Resource-Limited SeettingsLink provided by the sponsor.
Related trials for Post Spinal Anesthesia Shivering
Not yet recruitingPhase 4
Two Doses of IV Magnesium Sulfate for Prevention of Post-Spinal Shivering
Post Spinal Anesthesia Shivering
Not yet recruitingPhase 4
Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
Shivering, Postoperative Shivering
Not yet recruitingPhase 4
Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
Shivering, Hypothermia
Not yet recruitingPhase 4
Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean Section
Shivering, Post-Spinal Shivering
Not yet recruitingPhase 4
Efficacy of Intravenous Midazolam-Ketamine Combination Versus Placebo for Prevention of Post-Spinal Shivering in Elective Cesarean Section
Shivering, Post-Spinal Shivering
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone 0.1mg/kg and Dexamethasone 0.3mg/kg in people with Post Spinal Anesthesia Shivering, run by Assiut University.
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 5 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: opening soon, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
severity of PSAS (time frame: 60 minutes after operation). 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 31 May 2025.