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Active, not recruiting Not applicable

Nebulized vs. IV Ketamine in Preventing Shivering Post Spinal Anesthesia

NCT07055828 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-05-02
Last updated
2025-07-09

Condition(s) studied

Post Spinal Anesthesia Shivering

Investigational drug(s) / intervention(s)

Ketamine →Intranasal ketamine →Normal SalineSaline Inhalants

Ketamine: Patients received IV ketamine 0.25 mg/kg before Spinal anesthesia as a prophylactic drug

Intranasal ketamine: Patients received nebulized ketamine at a dose of 0.75 mg/kg adjusted to 5 ml by adding normal saline to be inhaled through a breath-actuated nebulizer

Normal Saline: Patients received Intravenous Normal saline

Saline Inhalants: Patients received nebulized Saline

Study summary

Shivering is an involuntary muscle activity, often triggered by hypothermia, that can occur after anesthesia. This is known as postanesthetic shivering (PAS) and is a common issue that increases oxygen demand, raises the risk of low oxygen levels, and can lead to complications after surgery.

Spinal anesthesia (SA) is a popular choice due to its quick action and effective numbing. However, it's frequently linked to shivering during and after the procedure.

To combat PAS, various methods have been used. Non-pharmacological approaches like insulation, continuous warming, and temperature management have been shown to reduce low body temperature during surgery and decrease shivering and complications afterward, aiding recovery.

Pharmacologically, certain medications can help. Intrathecal meperidine or intravenous (IV) ketamine are effective in preventing PAS. Intrathecal midazolam can also reduce shivering, unlike fentanyl. Additionally, IV ketamine infusion can lower the incidence of low blood pressure and shivering in patients receiving SA. Low-dose ketamine combined with dexmedetomidine, or dexmedetomidine alone, have also shown similar effectiveness in reducing shivering and postoperative nausea and vomiting during SA.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * Patients who were assigned for Inguinal Hernia hernioplasty; * Patients free of exclusion criteria were enrolled in the study. Exclusion Criteria: * Patients who were on the American Society of Anesthesiologists Physical Status classification (ASA) grade \>II; * Patients with body mass index (BMI) \>30 kg/m²; * Patients with Upper respiratory tract diseases; * Patients with spinal deformities or diseases; * Patients with coagulopathy, or allergies to the drugs used;

Primary outcome measure(s)

  • Effectiveness of Nebulized Ketamine on Post-Anesthesia Shivering (PAS) Incidence and Severity — 56 days
    This Study asses the effectiveness of the administered therapy in controlling Post-Anesthesia Shivering (PAS) as a reduction in both its incidence and severity. Specifically, effective control is indicated by a Bedside Shivering Assessment Score (BSAS) of less than 2 within the initial 60 minutes post-therapy, alongside a reduction in other associated adverse effects.

Trial sites (1)

FacilityCityRegionStatus
Tanta University Tanta El Gharbyia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07055828 on ClinicalTrials.gov ↗ ← All trials in Egypt