Nebulized vs. IV Ketamine in Preventing Shivering Post Spinal Anesthesia

N/AActive Not RecruitingNCT07055828

Tanta University120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

120

Conditions

Post Spinal Anesthesia Shivering

KetamineDRUG

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

Intranasal ketamineDRUG

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 SalineDRUG

Patients received Intravenous Normal saline

Saline InhalantsDRUG

Patients received nebulized Saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

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

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.

Time frame: 56 days