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临床试验/NCT07055828
NCT07055828进行中(未招募)不适用

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

Tanta University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年5月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
120
试验地点
1
主要终点
Effectiveness of Nebulized Ketamine on Post-Anesthesia Shivering (PAS) Incidence and Severity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who were assigned for Inguinal Hernia hernioplasty;
  • Patients free of exclusion criteria were enrolled in the study.

排除标准

  • 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;

研究组 & 干预措施

Group P (Placebo)

Active Comparator

Patients in this group met the study's inclusion criteria and received inactive solutions (saline) both through nebulization and intravenously, serving as a control.

干预措施: Normal Saline (Drug)

Group P (Placebo)

Active Comparator

Patients in this group met the study's inclusion criteria and received inactive solutions (saline) both through nebulization and intravenously, serving as a control.

干预措施: Saline Inhalants (Drug)

Group NK (Nebulized Ketamine)

Active Comparator

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.

干预措施: Intranasal ketamine (Drug)

Group NK (Nebulized Ketamine)

Active Comparator

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.

干预措施: Normal Saline (Drug)

Group IVK (Intravenous Ketamine)

Placebo Comparator

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.

干预措施: Ketamine (Drug)

Group IVK (Intravenous Ketamine)

Placebo Comparator

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.

干预措施: Saline Inhalants (Drug)

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Lotfy

Assistant Professor of Anesthesia, Pain Management and Surgical ICU

Tanta University

研究点 (1)

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