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NCT Number: NCT07055828

Nebulized vs. IV Ketamine in Preventing Shivering Post Spinal Anesthesia

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Post Spinal Anesthesia Shivering

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El Gharbyia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

ketamine

Drug

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

Intranasal ketamine

Drug

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

Drug

Patients received Intravenous Normal saline

Saline Inhalants

Drug

Patients received nebulized Saline

Primary outcomes

  1. Effectiveness of Nebulized Ketamine on Post-Anesthesia Shivering (PAS) Incidence and Severity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Nebulized Versus Intravenous Ketamine as Prophylaxis Against Spinal Anesthesia-induced Shivering and Hemodynamic Changes: A Placebo-controlled Prospective Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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