Nebulized vs. IV Ketamine in Preventing Shivering Post Spinal Anesthesia

Not Applicable

Active, not recruiting

• Conditions: Post Spinal Anesthesia Shivering
• Interventions: Drug: Normal Saline; Drug: Intranasal ketamine; Drug: Ketamine; Drug: Saline Inhalants

• Registration Number: NCT07055828
• Lead Sponsor: Tanta University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-02
• Status Verified: 2025-06
• Primary Completion: 2025-06-27
• Study First Submitted: 2025-06-28
• Study First Submitted QC: 2025-06-28
• Last Update Submitted: 2025-06-28
• Study First Posted: 2025-07-09
• Last Update Posted: 2025-07-09
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group P (Placebo)	Normal Saline	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 P (Placebo)	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)	Intranasal ketamine	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 NK (Nebulized Ketamine)	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)	Ketamine	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.
Group IVK (Intravenous Ketamine)	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.

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El Gharbyia, Egypt