The Effect of Different Doses of Dexamethasone on Post Spinal Anesthesia Shivering

NCT06999070 | Not Yet Recruiting DMC

• 1 other identifier: Dexamethasone and shivering
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Post Spinal Anesthesia Shivering

Keywords

Dexamethasone; Post spinal anesthesia shivering

Outcome Measures

Primary Outcomes (1)

• 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.

  60 minutes after operation

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients will take 0.1 mg/kg dexamethasone iv on incidence of Shivering after spinal anaethesia

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

Drug: Dexamethasone 0.3mg/kg

Interventions

Dexamethasone 0.1mg/kg DRUG

On incidence of Shivering after spinal anaethesia

Group A

Dexamethasone 0.3mg/kg DRUG

On incidence of Shivering after spinal anaethesia

Group B

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I-II.
• Both sexes.
• Age: 21-55 years old.
• Scheduled for lower limb orthopedic surgery.
• BMI less than 35 kg/m2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Links

• 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 an
• Adel Rizk Botros, Yasser M. Nasr, Wafaa Ibrahim Abd el Wahid Khalil. Comparative study between dexamethasone and ondansetron for prevention ofshivering during spinal anaethesia.
• Hunde Amsalu, Abebayehu Zemedkun, Teshome Ragasa, Yayeh Adamu. Evidence-Based Guideline on Prevention and Management of Shivering After Spinal Anesthesia in Resource-Limited Seettings

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A randomized, comparative study of different doses of intravenous dexamethasone for management of post spinal anesthesia shivering in lower limb orthopedic surgeries

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 31, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-05