Nebulized vs. IV Ketamine in Preventing Shivering Post Spinal Anesthesia

Tanta University

Status: Active, not recruiting

Conditions: Post Spinal Anesthesia Shivering

Treatments: Drug: Intranasal ketamine; Drug: Normal Saline; Drug: Saline Inhalants; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT07055828

36264PR1219/5/25

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups, including a placebo group

Group P (Placebo)

Active Comparator group

Description:

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

Treatment:

Drug: Saline Inhalants

Drug: Normal Saline

Group NK (Nebulized Ketamine)

Active Comparator group

Description:

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.

Treatment:

Drug: Normal Saline

Drug: Intranasal ketamine

Group IVK (Intravenous Ketamine)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Ketamine

Drug: Saline Inhalants