Nebulized vs. IV Ketamine in Preventing Shivering Post Spinal Anesthesia

NCT07055828 — Not applicable, Active not recruiting, 120 participants, Tanta University

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

Registry	NCT07055828
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	120 (Actual)
Sponsor	Tanta University (Other)
Conditions	Post Spinal Anesthesia Shivering
Interventions	Ketamine, Intranasal ketamine, Normal Saline, Saline Inhalants (Drug)
Dates	start 2025-05-02, primary completion 2025-06-27, completion 2025-07-15 (estimated), first posted 2025-07-09, last updated 2025-07-09
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group P (Placebo)	Active comparator	Drug: Normal Saline; Drug: Saline Inhalants	Patients in this group met the study's inclusion criteria and received inactive solutions (saline) both through nebulization and intravenously, serving as a control.
Group NK (Nebulized Ketamine)	Active comparator	Drug: Intranasal ketamine; Drug: Normal Saline	Patients in this group met the study's inclusion criteria and received ketamine via a nebulizer at a specific dose. They also received intravenous saline as a placebo.
Group IVK (Intravenous Ketamine)	Placebo comparator	Drug: Ketamine; Drug: Saline Inhalants	Patients in this group met the study's inclusion criteria and received ketamine intravenously as a prophylactic drug before spinal anesthesia. They also received nebulized saline as a placebo.

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

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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;

+Locations (1)

Facility	City	Country	Status
Tanta University	Tanta, El Gharbyia	Egypt

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