Nebulized vs. IV Ketamine in Preventing Shivering Post Spinal Anesthesia

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

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 Overview

• Status: Active, not recruiting
• Conditions: Post Spinal Anesthesia Shivering
• Intervention / Treatment: Drug: Normal Saline; Drug: Saline Inhalants; Drug: Intranasal ketamine; Drug: Ketamine

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Gharbyia
    • Tanta, El Gharbyia, Egypt, 13511
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group P (Placebo); Patients in this group met the study's inclusion criteria and received inactive solutions (saline) both through nebulization and intravenously, serving as a control.	Drug: Normal Saline; Patients received Intravenous Normal saline; Drug: Saline Inhalants; Patients received nebulized Saline
Active Comparator: Group NK (Nebulized 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.	Drug: Normal Saline; Patients received Intravenous Normal saline; Drug: Intranasal ketamine; 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
Placebo Comparator: Group IVK (Intravenous 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.	Drug: Saline Inhalants; Patients received nebulized Saline; Drug: Ketamine; Patients received IV ketamine 0.25 mg/kg before Spinal anesthesia as a prophylactic drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	56 days

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2025
• Primary Completion (Actual): June 27, 2025
• Study Completion (Estimated): July 15, 2025

Study Registration Dates

• First Submitted: June 28, 2025
• First Submitted That Met QC Criteria: June 28, 2025
• First Posted (Actual): July 9, 2025

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: June 28, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Neurotransmitter Agents; Anesthetics, Intravenous; Anesthetics, General; Excitatory Amino Acid Agents; Anesthetics, Dissociative; Excitatory Amino Acid Antagonists; Ketamine
• Other Study ID Numbers: 36264PR1219/5/25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No